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Lymphoma — Monthly Compass
May 01–31, 2026 • Priority Updates • 3–5 minute read
 
A curated, practice-minded digest of what moved in lymphoma this month — regulatory signals, clinical development, and the most practice-relevant publications.
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lymphoma updates
Key Highlights
Key Highlights
  • Practice-Changing Updates
    • On May 13, 2026, FDA granted accelerated approval to sonrotoclax (Beqalzi) as the first BCL‑2 inhibitor for relapsed/refractory mantle cell lymphoma after at least two prior therapies including a BTK inhibitor, with continued approval contingent on confirmatory benefit.
  • Key Clinical Development Updates
    • FDA aligned with Caribou Biosciences on the pivotal ANTLER‑3 Phase 3 design for vispacabtagene regedleucel (vispa‑cel) in second‑line LBCL, supported by RMAT status and existing Fast Track and Orphan Drug designations.
    • Pierre Fabre secured FDA Type A meeting alignment to proceed with tabelecleucel BLA resubmission in EBV+ post‑transplant lymphoproliferative disease, while Enterome received FDA Orphan Drug Designation for EO2463 in “watch‑and‑wait” indolent non‑Hodgkin lymphoma.
  • Important Clinical Trial Publications
    • The global phase 3 frontMIND trial reported that adding tafasitamab and lenalidomide to R‑CHOP significantly improved progression‑free survival versus R‑CHOP alone in previously untreated high‑risk DLBCL, with a higher incidence of adverse events including fatal treatment‑emergent events.
    • The EORTC‑1537‑COBRA phase 2 study showed that very‑early [18F]FDG‑PET‑guided switching from A‑AVD to BrECADD after one cycle achieved high efficacy with favorable safety in advanced‑stage classic Hodgkin lymphoma.
  • Key Conference Updates
    • At ASCO 2026, lymphoma programs emphasized earlier‑line immunochemotherapy optimization, expansion of outpatient fixed‑duration CD20×CD3 bispecific strategies (including chemo‑free/ADC combinations), and maturation of CAR T implementation with supportive real‑world evidence.
  • Emerging Themes & Macro-Trends
    • Strategic focus is shifting toward CELMoD‑enabled and ADC‑anchored frontline combinations, dual‑antigen CAR T constructs coupled with scalable site‑of‑care models, and fixed‑duration biologics designed for outpatient delivery.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • On May 13, 2026, the FDA granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma. This approval is for patients who have received at least two prior lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor.¹ (read more)
  • On May 13, 2026, the FDA approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax for newly diagnosed acute myeloid leukemia. This treatment is indicated for adults aged 75 years or older, or those with comorbidities preventing intensive induction chemotherapy.² (read more)
  • On May 27, 2026, the FDA approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm. BPDCN is an ultra-rare hematologic malignancy.³ (read more)
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • FDA granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.) for adults with relapsed or refractory mantle cell lymphoma after at least two prior lines of systemic therapy, including a BTK inhibitor. The decision was based on response rate; continued approval may be contingent on confirmatory evidence. ¹ (read more)
  • BeOne Medicines announced U.S. FDA accelerated approval of BEQALZI (sonrotoclax) as the first and only BCL‑2 inhibitor approved in mantle cell lymphoma, and highlighted prior FDA Breakthrough Therapy, Fast Track, and Orphan Drug designations. The company noted an ongoing confirmatory trial (CELESTIAL‑RRMCL) to verify clinical benefit. ² (read more)
  • Pierre Fabre Pharmaceuticals reported alignment with FDA following a Type A meeting on the resubmission pathway for the tabelecleucel BLA in EBV+ post‑transplant lymphoproliferative disease (a lymphoma subtype). The company stated it intends to proceed per the agreed path toward BLA resubmission. ³ (read more)
  • Caribou Biosciences announced FDA alignment on the pivotal ANTLER‑3 Phase 3 trial design for vispacabtagene regedleucel (vispa‑cel) in second‑line LBCL, enabled by the program’s RMAT designation. The update also reiterated that vispa‑cel holds FDA Fast Track and Orphan Drug designations for B‑cell non‑Hodgkin lymphoma. ⁴ (read more)
  • Lyell Immunopharma’s Q1 update confirmed that ronde‑cel (dual‑targeting CD19/CD20 CAR‑T) has FDA RMAT designation in both second‑ and third‑line LBCL and Fast Track designation for relapsed/refractory LBCL. The company expects pivotal data in 2027 followed by a planned BLA submission. ⁵ (read more)
  • Enterome announced U.S. FDA Orphan Drug Designation for EO2463 to treat “watch‑and‑wait” indolent non‑Hodgkin lymphoma. The company also reiterated FDA Fast Track designation previously granted for follicular lymphoma in the watch‑and‑wait setting. ⁶ (read more)
Conference
Major Conference Updates
Conference Information
  • ASCO 2026 Annual Meeting, Chicago, Illinois, May 29–June 2, 2026. Momentum centers on earlier-line immunochemotherapy optimization, scale-up of CD20xCD3 bispecifics (including chemo-free/ADC combos), and operational maturation of CAR T with real-world evidence. (read more)
  • Theme 1: Frontline Immunochemotherapy Upgrades
    • Significance: First-line DLBCL is moving beyond R-CHOP; the phase III frontMIND readout (tafasitamab + lenalidomide + R-CHOP) signals a clinically meaningful PFS benefit and potential curative-impact shift. Concurrently, BMS is piloting the CELMoD golcadomide + pola-RCHP to intensify induction biology. (read more)
    • Mechanism insights / clinical impact: Tafasitamab (anti‑CD19) plus lenalidomide may enhance ADCC/immune priming atop R‑CHOP; golcadomide (CELMoD) augments T/NK function layered onto anti‑CD79b ADC polatuzumab within R‑CHP, aiming for deeper early disease control. (read more)
    • Patient populations affected: Newly diagnosed aggressive B‑cell lymphomas (DLBCL/HGBL), including fit patients in standard induction and those suitable for R‑CHP backbones. (read more)
  • Theme 2: CD20xCD3 Bispecifics Scale Across Settings (and Pair with ADCs)
    • Significance: Programs emphasize fixed‑duration, outpatient practicality and movement into earlier lines; breadth of epcoritamab presentations (monotherapy, combinations, elderly‑unfit frontline) underscores category durability. (read more)
    • Mechanism insights / clinical impact: Epcoritamab (subcutaneous CD3×CD20) extends from R/R LBCL/FL into unfit 1L DLBCL (R‑miniCVP combinations); Roche’s SUNMO evaluates Lunsumio (mosunetuzumab) + Polivy (polatuzumab vedotin) as a chemotherapy‑free, fixed‑duration strategy vs R‑GemOx in transplant‑ineligible second line. (read more)
    • Patient populations affected: R/R LBCL ineligible for transplant, R/R FL, and newly diagnosed elderly/frail DLBCL—settings where tolerability, logistics, and time‑limited therapy are decisive. (read more)
  • Theme 3: CAR T Evolution—Dual‑Target Constructs and Real‑World Operations
    • Significance: Evidence is expanding from efficacy to implementation—resource utilization across non‑FACT centers and large real‑world cohorts point to broader access; next‑gen dual‑target constructs aim to mitigate antigen escape. (read more)
    • Mechanism insights / clinical impact: KITE‑753 (autologous anti‑CD19/CD20 CAR T) advances in LBCL; parallel posters detail axi‑cel outcomes and health‑care resource utilization, while Breyanzi (lisocabtagene maraleucel) adds real‑world data in CLL/MCL—together signaling durable benefit with improving operational feasibility. (read more)
    • Patient populations affected: CAR‑naive R/R LBCL, and broader B‑cell lymphoma cohorts (including CLL/MCL) treated across diverse U.S. centers. (read more)
  • Significance
    • Expected clinical or translational readouts: Deeper ASCO data slices for frontMIND and SUNMO; expanded epcoritamab program outputs (EPCORE DLBCL‑1/FL‑1, elderly‑unfit 1L). (read more)
    • Regulatory or policy implications: frontMIND results are framed by ASCO communications as supportive of regulatory submissions and frontline standard reconsideration. (read more)
    • Potential shifts in standard of care: Movement toward tafasitamab + lenalidomide + R‑CHOP in 1L DLBCL; chemo‑free bispecific/ADC regimens for 2L transplant‑ineligible LBCL; broader CAR T adoption informed by real‑world feasibility. (read more)
    • Strategic implications: Prioritize CELMoD‑enabled and ADC‑anchored frontline combinations; invest in subcutaneous, fixed‑duration bispecifics; differentiate CAR T with dual‑antigen targeting and site‑of‑care models that reduce HCRU barriers. (read more)
Publications Related to Approved Drugs
Publications related to lymphoma:
: 'Development of a Taste-Masked, Dose-Flexible, Multiparticulate Pediatric Dosage Form: Case Study of Crizotinib, a Challenging Pediatric Formulation.' (anaplastic large cell lymphoma)
: 'First-line immunochemotherapy for indolent lymphoma does not affect muscle volume: a post hoc analysis of 472 patients in long-term remissions from the GALLIUM study.' (indolent lymphoma)
: 'Fixed-Duration Subcutaneous Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma: Pivotal Phase 2 Primary Analysis.' (follicular lymphoma)
: 'Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory Richter transformation.' (Richter transformation to diffuse large B-cell lymphoma)
/: 'Indirect Treatment Comparisons of Lisocabtagene Maraleucel Versus Axicabtagene Ciloleucel and Tisagenlecleucel in Third-Line or Later Relapsed or Refractory Follicular Lymphoma.' (follicular lymphoma) Let's summarize each:
Fixed-Duration Subcutaneous Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma: Pivotal Phase 2 Primary Analysis. Subcutaneous mosunetuzumab demonstrated non-inferior pharmacokinetics and consistent efficacy compared to the intravenous formulation, achieving a 76.6% overall response rate and a 61.7% complete response rate in heavily pretreated patients. The subcutaneous route also offered a favorable safety profile with lower rates and severity of cytokine release syndrome, highlighting its potential to improve patient convenience and outpatient accessibility. ()
Indirect Treatment Comparisons of Lisocabtagene Maraleucel Versus Axicabtagene Ciloleucel and Tisagenlecleucel in Third-Line or Later Relapsed or Refractory Follicular Lymphoma. A matching-adjusted indirect comparison revealed that lisocabtagene maraleucel (liso-cel) achieved a significantly higher complete response rate and improved safety profile, including reduced severe cytokine release syndrome and neurological events, compared to axicabtagene ciloleucel. These findings suggest liso-cel may be a preferred, highly efficacious, and safer CAR T-cell therapy option for patients with third-line or later relapsed/refractory follicular lymphoma. () Wait, the generic drug for is axicabtagene ciloleucel. For it's tisagenlecleucel. I will use.
Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory Richter transformation. In a cohort of patients with chemorefractory Richter transformation, mosunetuzumab yielded a 40% overall response rate and a 20% complete response rate, with some responses being highly durable and enabling successful bridging to allogeneic stem cell transplant. Given its manageable toxicity profile, primarily low-grade cytokine release syndrome, mosunetuzumab represents a promising therapeutic strategy for this aggressive and difficult-to-treat lymphoma. ()
Development of a Taste-Masked, Dose-Flexible, Multiparticulate Pediatric Dosage Form: Case Study of Crizotinib, a Challenging Pediatric Formulation. A decade-long clinical development program successfully produced a taste-masked, pH-independent microsphere formulation of crizotinib that achieved acceptable palatability and bioequivalence to the adult capsule. This dose-flexible pediatric formulation significantly improves tolerability and adherence for children with anaplastic large cell lymphoma, providing a practical framework for future pediatric oncology drug development. ()
First-line immunochemotherapy for indolent lymphoma does not affect muscle volume: a <i>post hoc</i> analysis of 472 patients in long-term remissions from the GALLIUM study. A post hoc analysis of the GALLIUM trial demonstrated that first-line immunochemotherapy does not negatively impact muscle volume in patients achieving long-term remission. These findings provide reassuring safety data regarding the long-term physical and metabolic health of patients treated for indolent lymphoma. () Let's order them by importance:
Subcutaneous Mosunetuzumab in FL ()
CAR-T comparisons in FL ()
Mosunetuzumab in Richter transformation ()
Crizotinib pediatric formulation ()
Immunochemotherapy and muscle volume in indolent lymphoma () Wait, I should also check if there are any other lymphoma publications.: ALL (leukemia): Myelofibrosis: Multiple Myeloma: Multiple Myeloma: NSCLC: Multiple Myeloma: AML: Systemic mastocytosis: Multiple Myeloma: Multiple Myeloma So the 5 lymphoma publications are correct. Let's refine the summaries to ensure they are 2-3 sentences, professional, and actionable.
Fixed-Duration Subcutaneous Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma: Pivotal Phase 2 Primary Analysis. Subcutaneous mosunetuzumab demonstrated non-inferior pharmacokinetics and consistent efficacy compared to the intravenous formulation, achieving a 76.6% overall response rate and a 61.7% complete response rate in heavily pretreated patients. The subcutaneous route also offered a favorable safety profile with lower rates and severity of cytokine release syndrome, highlighting its potential to improve patient convenience and outpatient accessibility. ()
Indirect Treatment Comparisons of Lisocabtagene Maraleucel Versus Axicabtagene Ciloleucel and Tisagenlecleucel in Third-Line or Later Relapsed or Refractory Follicular Lymphoma. A matching-adjusted indirect comparison revealed that lisocabtagene maraleucel (liso-cel) achieved a significantly higher complete response rate and an improved safety profile compared to axicabtagene ciloleucel. Specifically, liso-cel demonstrated reduced odds of severe cytokine release syndrome and neurological events, suggesting it may be a preferred, highly efficacious CAR T-cell therapy option for patients with relapsed/refractory follicular lymphoma. ()
Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory Richter transformation. In a cohort of patients with chemorefractory Richter transformation, mosunetuzumab yielded a 40% overall response rate and a 20% complete response rate, with some responses being highly durable and enabling successful bridging to allogeneic stem cell transplant. Given its manageable toxicity profile, primarily low-grade cytokine release syndrome, mosunetuzumab represents a promising therapeutic strategy for this aggressive and difficult-to-treat lymphoma. ()
Development of a Taste-Masked, Dose-Flexible, Multiparticulate Pediatric Dosage Form: Case Study of Crizotinib, a Challenging Pediatric Formulation. A decade-long clinical development program successfully produced a taste-masked, pH-independent microsphere formulation of crizotinib that achieved acceptable palatability and bioequivalence to the adult capsule. This dose-flexible pediatric formulation significantly improves tolerability and adherence for children with anaplastic large cell lymphoma, providing a practical framework for future pediatric oncology drug development. ()
First-line immunochemotherapy for indolent lymphoma does not affect muscle volume: a <i>post hoc</i> analysis of 472 patients in long-term remissions from the GALLIUM study. A post hoc analysis of the GALLIUM trial demonstrated that first-line immunochemotherapy does not negatively impact muscle volume in patients achieving long-term remission. These findings provide reassuring safety data regarding the long-term physical and metabolic health of patients treated for indolent lymphoma. () Wait, the prompt asks for:
A clean list of key publication bullet points (each 2–3 sentences) starting with name of the publication in bold.
At the end of each bullet point, include the NCTID of the associated clinical trial in parentheses.
At the end of each bullet point, include the id of the associated clinical trial as |PMID:id|.
At the end of each bullet point, include the phase of the associated clinical trial as .
At the end of each bullet point, include the generic drugs of the associated clinical trial as . Let's double check the formatting.
Title. Sentence 1. Sentence 2. (NCTID) |PMID:id| Looks good. I will output just the bulleted summaries.
Fixed-Duration Subcutaneous Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma: Pivotal Phase 2 Primary Analysis. Subcutaneous mosunetuzumab demonstrated non-inferior pharmacokinetics and consistent efficacy compared to the intravenous formulation, achieving a 76.6% overall response rate and a 61.7% complete response rate in heavily pretreated patients. The subcutaneous route also offered a favorable safety profile with lower rates and severity of cytokine release syndrome, highlighting its potential to improve patient convenience and outpatient accessibility. ()
Indirect Treatment Comparisons of Lisocabtagene Maraleucel Versus Axicabtagene Ciloleucel and Tisagenlecleucel in Third-Line or Later Relapsed or Refractory Follicular Lymphoma. A matching-adjusted indirect comparison revealed that lisocabtagene maraleucel (liso-cel) achieved a significantly higher complete response rate and an improved safety profile compared to axicabtagene ciloleucel. Specifically, liso-cel demonstrated reduced odds of severe cytokine release syndrome and neurological events, suggesting it may be a preferred, highly efficacious CAR T-cell therapy option for patients with relapsed/refractory follicular lymphoma. ()
Mosunetuzumab monotherapy is active and tolerable in patients with relapsed/refractory Richter transformation. In a cohort of patients with chemorefractory Richter transformation, mosunetuzumab yielded a 40% overall response rate and a 20% complete response rate, with some responses being highly durable and enabling successful bridging to allogeneic stem cell transplant. Given its manageable toxicity profile, primarily low-grade cytokine release syndrome, mosunetuzumab represents a promising therapeutic strategy for this aggressive and difficult-to-treat lymphoma. ()
Development of a Taste-Masked, Dose-Flexible, Multiparticulate Pediatric Dosage Form: Case Study of Crizotinib, a Challenging Pediatric Formulation. A decade-long clinical development program successfully produced a taste-masked, pH-independent microsphere formulation of crizotinib that achieved acceptable palatability and bioequivalence to the adult capsule. This dose-flexible pediatric formulation significantly improves tolerability and adherence for children with anaplastic large cell lymphoma, providing a practical framework for future pediatric oncology drug development. ()
First-line immunochemotherapy for indolent lymphoma does not affect muscle volume: a <i>post hoc</i> analysis of 472 patients in long-term remissions from the GALLIUM study. A post hoc analysis of the GALLIUM trial demonstrated that first-line immunochemotherapy does not negatively impact muscle volume in patients achieving long-term remission. These findings provide reassuring safety data regarding the long-term physical and metabolic health of patients treated for indolent lymphoma. ()
New Publications Related to Drugs in Clinical Trial Development
Indirect Treatment Comparisons of Lisocabtagene Maraleucel Versus Axicabtagene Ciloleucel and Tisagenlecleucel in Third-Line or Later Relapsed or Refractory Follicular Lymphoma. Matching-adjusted indirect comparisons suggest that lisocabtagene maraleucel (liso-cel) offers a higher complete response rate and improved safety profile compared to axicabtagene ciloleucel, and similar safety with a higher response rate compared to tisagenlecleucel in patients with third-line or later relapsed/refractory follicular lymphoma. These findings highlight liso-cel as a potentially preferred CAR T-cell therapy option in this heavily pretreated population. ()
Genetics and MRD for therapy allocation in adults with Philadelphia chromosome-negative acute lymphoblastic leukemia. The combination of genetic risk profiling and measurable residual disease (MRD) assessment enables accurate stratification of adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia for either allogeneic hematopoietic stem cell transplant or chemotherapy. This integrated approach optimizes therapy allocation, demonstrating high overall survival rates for MRD-negative patients without high-risk genetics who receive chemotherapy alone. ()
Venetoclax Plus Pediatric Regimen in Adolescents and Adults with Ph-Negative Acute Lymphoblastic Leukemia. The addition of the BCL-2 inhibitor venetoclax to pediatric-inspired chemotherapy significantly improved measurable residual disease negativity and survival outcomes in adolescents and adults with newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia. This combination demonstrated a manageable safety profile, suggesting it as a promising first-line therapeutic strategy for this patient population. ()
Tafasitamab plus lenalidomide and R-CHOP versus R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma (frontMIND): a global, phase 3, randomised, double-blind, placebo-controlled trial. The addition of tafasitamab and lenalidomide to standard R-CHOP significantly improved progression-free survival compared to R-CHOP alone in patients with previously untreated, high-risk diffuse large B-cell lymphoma. However, this combination was associated with an increased incidence of adverse events, including fatal treatment-emergent events, necessitating careful patient selection and monitoring. ()
Data-driven computational modeling of CAR-T cell function. A novel computational model utilizing in vitro assay data revealed that while pre-treatment CAR-T cell functional parameters vary significantly between patients, they do not predict initial therapeutic responses in diffuse large B-cell lymphoma. However, specific kinetic properties, such as increased CAR-T cell responsiveness and cooperativity, were correlated with durable therapy responses and may help predict disease relapse. ()
Very early [18F]FDG-PET-guided targeted therapy in untreated advanced-stage classic Hodgkin lymphoma (EORTC-1537-COBRA): primary results of a single-arm, multicentre, phase 2 trial. Very early PET-guided treatment adaptation, switching from A-AVD to BrECADD after one cycle for patients with a positive PET scan, demonstrated high efficacy and a favorable safety profile in advanced-stage classic Hodgkin lymphoma. This strategy effectively limits exposure to intensive chemotherapy for the majority of patients while maintaining excellent progression-free survival. ()
Three-year follow-up of epcoritamab therapy in Japanese patients with relapsed/refractory follicular lymphoma in EPCORE NHL-3. Three-year follow-up data from the EPCORE NHL-3 trial confirms that epcoritamab monotherapy provides deep, durable responses and a favorable long-term safety profile in Japanese patients with heavily pretreated relapsed/refractory follicular lymphoma. The high rates of complete response and minimal residual disease negativity underscore its potential as a highly effective treatment option in this setting. ()
Diffuse Large B-Cell Lymphoma Presenting in a Background of Rosai-Dorfman Disease. A case report highlights the rare coexistence of diffuse large B-cell lymphoma (DLBCL) within the background of Rosai-Dorfman disease, emphasizing the need for careful histopathological evaluation in patients presenting with generalized lymphadenopathy unresponsive to initial therapy. Successful treatment with a targeted immunochemotherapy regimen underscores the importance of accurate diagnosis for optimal patient outcomes. ()
Phase III randomized studies of mevrometostat and enzalutamide in metastatic prostate cancer (MEVPRO-1 and MEVPRO-2): trial protocols. The MEVPRO-1 and MEVPRO-2 phase III trials are evaluating the efficacy and safety of combining the EZH2 inhibitor mevrometostat with enzalutamide in patients with metastatic castration-resistant prostate cancer. These studies aim to determine if this novel combination can significantly improve radiographic progression-free survival compared to standard therapies in both pretreated and treatment-naïve populations. ()
Refining busulfan exposure enhances pediatric ALL HSCT outcomes: insights from the International FORUM study. Therapeutic drug monitoring to achieve an optimal busulfan exposure window (cAUC 73.3-98.0 mg.h/L) significantly improves event-free and graft-versus-host disease-free relapse-free survival in pediatric patients with acute lymphoblastic leukemia undergoing allogeneic hematopoietic stem cell transplantation. This personalized dosing strategy offers outcomes comparable to total-body irradiation, suggesting it as a viable, less toxic alternative conditioning regimen. ()
Epcoritamab Monotherapy as Outpatient Treatment for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Interim Results From EPCORE NHL-6. Interim results from the EPCORE NHL-6 trial demonstrate that outpatient administration and monitoring of the first full dose of epcoritamab is feasible and safe for patients with relapsed/refractory diffuse large B-cell lymphoma. The incidence and severity of cytokine release syndrome and neurotoxicity were manageable and consistent with previous inpatient studies, supporting a shift towards outpatient care models. ()
Docirbrutinib is a pan-mutant BTK inhibitor and inhibits B-cell receptor signaling in chronic lymphocytic leukemia cells in preclinical and early clinical investigations. Docirbrutinib, a novel noncovalent BTK inhibitor, demonstrated potent activity against a wide range of BTK mutations, including those conferring resistance to both covalent and other noncovalent inhibitors, in preclinical models of chronic lymphocytic leukemia. Early clinical data confirmed its ability to inhibit B-cell receptor signaling and decrease disease biomarkers, highlighting its potential to overcome resistance in heavily pretreated patients. ()
Total marrow and lymphoid irradiation in combination with cyclophosphamide and etoposide before haematopoietic cell transplantation for relapsed or refractory acute leukaemia: a single-centre, open-label, phase 2 trial. The combination of total marrow and lymphoid irradiation with high-dose cyclophosphamide and etoposide proved to be a safe and effective conditioning regimen prior to allogeneic hematopoietic cell transplantation in patients with relapsed or refractory acute leukemia. This targeted radiation approach minimized organ toxicity while achieving encouraging 2-year progression-free survival rates. ()
Elraglusib and chemotherapy in metastatic pancreatic ductal adenocarcinoma: a randomized controlled phase 2 trial. The addition of the GSK-3β inhibitor elraglusib to gemcitabine and nab-paclitaxel significantly improved overall survival and 1-year survival rates compared to chemotherapy alone in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. These findings, along with a manageable safety profile, support the advancement of this combination into phase 3 clinical trials. ()
Safety, tolerability and immunogenicity of vaccine ALZ-101 in patients with early Alzheimer's disease: randomised, controlled trial. The ALZ-101 vaccine, targeting neurotoxic amyloid-β oligomers, demonstrated a favorable safety profile and elicited robust, durable antibody responses in patients with early Alzheimer's disease. While exploratory biomarker data suggest a potential disease-modifying effect, further large-scale trials are needed to confirm clinical efficacy. ()
Venetoclax in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors: Results of a Phase 1 Study. Venetoclax, both as monotherapy and in combination with cyclophosphamide and topotecan, demonstrated a predictable safety profile and modest clinical activity in pediatric and young adult patients with relapsed/refractory solid tumors, including neuroblastoma. The recommended phase 2 dose was established, supporting further investigation of this BCL-2 inhibitor in this patient population. ()
Duvelisib Induces Deep Responses in Peripheral T-Cell Lymphoma: Final Results of the Phase II PRIMO Trial of Duvelisib in Relapsed/Refractory Peripheral T-Cell Lymphoma. Duvelisib monotherapy demonstrated significant clinical activity and a manageable safety profile in patients with relapsed/refractory peripheral T-cell lymphoma, particularly within the angioimmunoblastic T-cell lymphoma subgroup. These final phase II results provide a strong rationale for the continued development of this dual PI3K-δ/γ inhibitor in this challenging disease setting. ()
Toxicity from asparaginase during acute lymphoblastic leukemia induction: A report from the Children's Oncology Group. A large-scale analysis revealed that older age, obesity, and high body surface area significantly increase the risk of asparaginase-associated toxicities during induction therapy for acute lymphoblastic leukemia. These findings underscore the need for targeted preventive strategies and closer monitoring in these high-risk patient subgroups to optimize treatment outcomes. ()
Development of a Taste-Masked, Dose-Flexible, Multiparticulate Pediatric Dosage Form: Case Study of Crizotinib, a Challenging Pediatric Formulation. The development of a taste-masked, multiparticulate formulation of crizotinib successfully overcame significant palatability and absorption challenges associated with earlier liquid formulations in pediatric patients. This case study provides a valuable framework for the clinical development and commercialization of acceptable and effective pediatric dosage forms for poorly palatable oncology drugs. ()
Nivolumab with or without vinblastine for first-line treatment of elderly patients with Hodgkin lymphoma and coexisting medical conditions: the Niviniho phase II Lysa study. Nivolumab, either alone or combined with vinblastine, is a feasible first-line treatment option for elderly, frail patients with Hodgkin lymphoma who are unfit for standard chemotherapy, demonstrating a manageable safety profile. However, the objective response rate with nivolumab monotherapy was low, indicating a need for more effective combination strategies in this vulnerable population. ()
Tucidinostat Plus R-CHOP vs R-CHOP in MYC/BCL2 Double-Expressor Diffuse Large B-Cell Lymphoma: A Randomized Clinical Trial. The addition of the epigenetic modulator tucidinostat to standard R-CHOP significantly improved event-free survival and complete response rates compared to R-CHOP alone in patients with newly diagnosed MYC/BCL2 double-expressor diffuse large B-cell lymphoma. This novel combination offers a promising first-line therapeutic approach for this high-risk population, with manageable toxicity. ()
A phase 1 trial of romidepsin, azacitidine, dexamethasone, and lenalidomide in relapsed or refractory T-cell lymphoma. The combination of romidepsin, azacitidine, dexamethasone, and lenalidomide demonstrated high response rates in patients with highly refractory T-cell lymphoma, although the responses were not durable. This multiagent regimen effectively served as a bridge to consolidation therapies, such as allogeneic transplantation, highlighting its potential utility in this challenging clinical scenario. ()
Selinexor and Venetoclax Combination in Patients With Relapsed or Refractory Acute Myeloid Leukemia. The combination of selinexor and venetoclax was feasible and showed preliminary activity in heavily pretreated patients with relapsed/refractory acute myeloid leukemia, with no new safety signals identified. However, overall survival outcomes remained poor, suggesting that further optimization, potentially with next-generation XPO1 inhibitors, is needed to overcome venetoclax resistance. ()
The effectiveness of long-lasting spatial repellent emanators against malaria in humanitarian crisis settings in northern Nigeria: a two-arm pragmatic, open-label, controlled trial. The deployment of long-lasting spatial repellent emanators significantly reduced malaria infection incidence and vector density in internally displaced persons camps in Nigeria, demonstrating high acceptability among residents. These findings support the use of spatial repellents as an effective and feasible vector control intervention in protracted humanitarian crises. ()
Long-term outcomes of CNCT19 chimeric antigen receptor T-cell therapy in relapsed or refractory aggressive B-cell lymphoma. Long-term follow-up of the CNCT19 CAR T-cell therapy, utilizing a novel CD19-binding clone, confirmed its curative potential and favorable safety profile in patients with relapsed or refractory aggressive B-cell lymphoma. The sustained progression-free and overall survival rates highlight CNCT19 as a promising therapeutic option for this patient population. ()
Olokizumab Improves Patient-Reported Outcomes in Patients with Active Rheumatoid Arthritis up to 106 Weeks (Results from the Open-Label Extension of Phase III Randomized Clinical Trials). Long-term treatment with olokizumab resulted in sustained and clinically meaningful improvements in patient-reported outcomes, including pain, physical function, and fatigue, in patients with active rheumatoid arthritis refractory to methotrexate or TNF inhibitors. These findings support the durable benefits of olokizumab on health-related quality of life over a 106-week period. ()
Lipid Nanoparticle-encapsulated mRNA-2752 Encoding Human OX40L, IL-23, and IL-36γ Plus Durvalumab Induces an Immunostimulatory Effect Within the Tumor Microenvironment in Patients with Advanced Solid Tumors. Intratumoral administration of mRNA-2752, alone or in combination with durvalumab, demonstrated manageable safety and promising antitumor activity, particularly in patients with checkpoint inhibitor-resistant melanoma. Biomarker analyses confirmed a sustained inflammatory response within the tumor microenvironment, supporting the potential of mRNA-based therapeutics in advanced cancer. ()
Safety and activity of pirtobrutinib in patients with relapsed or refractory Waldenström macroglobulinaemia: 5-year follow-up of the open-label, multicentre, phase 1/2 BRUIN trial. Five-year follow-up data from the BRUIN trial demonstrate that the non-covalent BTK inhibitor pirtobrutinib is highly active and well-tolerated in patients with relapsed or refractory Waldenström macroglobulinemia, including those previously treated with covalent BTK inhibitors. These findings establish pirtobrutinib as a promising therapeutic option for this patient population, addressing a critical need for effective treatments following covalent BTKi failure. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in lymphoma updated from 2026-05-01 to 2026-05-31:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation1-1---2
Not Yet Recruiting1862313-51
Recruiting3937771253182
Available-------
Approved for Marketing-------
Active, Not Recruiting311576322-147
Completed2-1-2-5
Total91581785523387
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
DZD8586 NCT07454863 COMPLETED A Phase I, Single-center, Non-randomized, Open-label, Mass Balance Study of Orally Administered [14C]-DZD8586 in Healthy Adult Male Participants 2026-04-06
SAR442257 NCT04401020 COMPLETED An Open-label, First-in-human, Single Agent, Dose Escalation Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442257 in Patients With Relapsed and Refractory Multiple Myeloma and Relapsed and Refractory Non-Hodgkin Lymphoma 2026-05-11
Opemalirsen (AZD2373) NCT07154901 ACTIVE_NOT_RECRUITING A Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373) 2026-06-15
Oxaliplatin, : Rituximab, Gemcitabine, Atezolizumab NCT03321643 ACTIVE_NOT_RECRUITING A Pilot Phase I Study of Atezolizumab (MPDL3280A) in Combination With Immunogenic Chemotherapy (Gemcitabine-Oxaliplatin) and Rituximab for Transformed Diffuse Large B-Cell Lymphoma 2026-06-30
[No Drug Info] NCT05377827 ACTIVE_NOT_RECRUITING Phase 1 Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies 2026-06-30
Copanlisib, : Ipilimumab, : Nivolumab NCT03502733 ACTIVE_NOT_RECRUITING Phase Ib Study of Copanlisib in Combination With Nivolumab or With Nivolumab and Ipilimumab 2026-07-01
bleximenib, 14C-bleximenib NCT07295951 RECRUITING An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants With Acute Leukemia 2026-07-13
: Blinatumomab, : Ipilimumab, : Nivolumab NCT02879695 ACTIVE_NOT_RECRUITING A Phase 1 Study of Blinatumomab in Combination With Checkpoint Inhibitor(s) of PD-1 (Nivolumab) or Both PD-1 (Nivolumab) and CTLA-4 (Ipilimumab) in Patients With Poor-Risk, Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia 2026-07-18
: Rituximab, Ibrutinib, Lenalidomide NCT02160015 ACTIVE_NOT_RECRUITING A Phase 1 Study of Lenalidomide and Ibrutinib in Combination With Rituximab in Relapsed and Refractory CLL and SLL 2026-08-13
: PIT565 NCT05397496 ACTIVE_NOT_RECRUITING A Phase I, Open-label, Multi-center Study of PIT565 in Patients With Relapsed and/or Refractory B-cell Malignancies 2026-08-20
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
: Zilovertamab vedotin NCT05144841 COMPLETED A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-004) 2026-04-21
: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine NCT02506933 ACTIVE_NOT_RECRUITING A Phase II Randomized, Placebo-Controlled, Multicenter Trial to Evaluate the Protective Function of a CMV-MVA Triplex Vaccine in Recipients of an Allogeneic Hematopoietic Stem Cell Transplant 2026-06-09
Azacitidine, Anti-PD-1 monoclonal antibody, Lenalidomide NCT05182957 RECRUITING Clinical Study on the Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma 2026-06-15
Lenalidomide, Rituximab NCT01446133 ACTIVE_NOT_RECRUITING Combination of Lenalidomide and Rituximab in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL-SLL) as Initial Treatment or Subsequent Therapy 2026-06-30
Carboplatin, Ifosfamide, : Nivolumab, Etoposide NCT03016871 ACTIVE_NOT_RECRUITING A Phase II Trial of Response-Adapted Second-Line Therapy for Hodgkin Lymphoma Using Anti-PD-1 Antibody Nivolumab ? ICE Chemotherapy as a Bridge to Autologous Hematopoietic Cell Transplant (NICE Trial) 2026-06-30
: Rituximab, Ibrutinib NCT02007044 ACTIVE_NOT_RECRUITING Ibrutinib vs Ibrutinib + Rituximab (i vs iR) in Patients With Relapsed (CLL) 2026-06-30
Selpercatinib NCT04320888 ACTIVE_NOT_RECRUITING NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-292 in Patients With Tumors Harboring RET Gene Alterations 2026-06-30
: Epcoritamab, Lenalidomide NCT06112847 ACTIVE_NOT_RECRUITING A Phase 2 Study of Epcoritamab and Lenalidomide (E-Len) in Patients With Previously Untreated Follicular Lymphoma (FL) 2026-07-17
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Pegaspargase, Cyclophosphamide, Thioguanine, Vincristine Sulfate, Cytarabine, Methotrexate, Mercaptopurine, Dexamethasone, Doxorubicin Hydrochloride, Leucovorin Calcium NCT01190930 COMPLETED Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy) 2026-03-31
Cyclophosphamide, Vincristine Placebo, Polatuzumab Vedotin, Doxorubicin, Prednisone, Rituximab NCT03274492 COMPLETED A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma 2026-04-30
Crizotinib, Alectinib NCT03194893 ACTIVE_NOT_RECRUITING A Multicenter, International, Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer 2026-05-30
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
No phase 4 trials completing within the next three months.
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