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LymphomaSeptember 2026
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Lymphoma — Monthly Compass
Sep 01–30, 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
    • Phase III CELESTIMO demonstrated that Lunsumio (mosunetuzumab) plus lenalidomide significantly improved progression-free survival in previously treated follicular lymphoma and serves as the confirmatory study to convert Lunsumio’s accelerated/conditional approval to full approval and support a second-line or later indication.
    • Canada approved epcoritamab plus lenalidomide‑rituximab (R2) for relapsed/refractory follicular lymphoma on September 24, 2026, formalizing a chemo‑free, fixed‑duration option in this setting.
  • Key Clinical Development Updates
    • FDA recently accepted the sBLA for subcutaneous Lunsumio (VELO) plus Polivy in second‑line or later DLBCL, reflecting continued U.S. regulatory engagement for this regimen.
    • FDA cleared IASO208, a CD20‑targeted in vivo CAR‑T and the first China‑originated lentiviral vector–based in vivo CAR‑T to receive U.S. IND clearance, and ADC Therapeutics disclosed it is assessing regulatory approaches for ZYNLONTA after a pre‑sBLA meeting raised concerns about LOTIS‑5 results and its ability to maintain U.S. accelerated approval.
  • Key Conference Updates
    • At SOHO 2026, adding tafasitamab plus lenalidomide to R‑CHOP in high‑risk frontline DLBCL/HGBL improved PFS (HR 0.75; 2‑year PFS 71.1% vs 62.9%) with higher ctDNA MRD negativity (81.3% vs 66.7%) and manageable toxicity, positioning immunotherapy add‑ons to challenge R‑CHOP and complement POLARIX‑era practice.
    • TRIANGLE supported omitting ASCT in frontline MCL, while real‑world lisocabtagene maraleucel delivered ORR 89%/CR 79%, 6‑month PFS 79%/OS 92%, with 39% outpatient treatment and 2% 6‑month non‑relapse mortality, validating efficacy and outpatient feasibility.
  • Emerging Themes & Macro-Trends
    • Chemo‑free, fixed‑duration bispecific combinations are consolidating 2L+ FL care while outpatient‑deliverable cellular therapies scale in practice and ASCT recedes in MCL.
    • Biomarker‑driven triage is advancing as end‑of‑treatment MRD negativity aligns with benefit in intensified frontline regimens and high CXCR4 expression predicts ~20% worse CAR T responses, prompting CXCR4‑inhibition hypotheses and investment in MRD/CXCR4 testing pathways.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-09-01 and 2026-09-30 about lymphoma.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • IASO Bio announced FDA clearance of the IND for IASO208, a CD20‑targeted in vivo CAR‑T therapy, enabling a planned Phase 1b U.S. study in relapsed/refractory B‑cell non‑Hodgkin lymphoma. The company highlighted that IASO208 is the first China‑originated lentiviral vector–based in vivo CAR‑T to receive FDA IND clearance. (prnewswire.com)¹ (read more)
  • Genentech reported that the Phase III CELESTIMO trial of Lunsumio (mosunetuzumab) plus lenalidomide in previously treated follicular lymphoma met its primary endpoint and serves as a confirmatory study required to convert Lunsumio’s accelerated/conditional approval to full approval and support a 2L+ indication. The U.S. indication section also reiterates that the current approval is “conditional” (accelerated) and based on response rate, underscoring ongoing regulatory obligations. (gene.com)²
  • Roche issued a companion release on CELESTIMO noting its role as the confirmatory study to convert Lunsumio monotherapy’s accelerated/conditional approval in 3L+ FL to full approval and to secure a 2L+ FL indication. The company also stated that FDA recently accepted the sBLA for subcutaneous Lunsumio (VELO) plus Polivy in 2L+ DLBCL, reflecting continued U.S. regulatory engagement. (roche.com)³
  • ADC Therapeutics, in a conference participation notice, disclosed it is assessing regulatory approaches for ZYNLONTA after a recent FDA pre‑sBLA meeting raised concerns about LOTIS‑5 results; the company referenced both the timing and potential outcome of an sBLA and its ability to maintain U.S. accelerated approval. The update explicitly cites ongoing FDA interactions and potential pathways to full approval for DLBCL. (ir.adctherapeutics.com)⁴
  • Cellectar Biosciences announced an abstract presentation in Waldenström macroglobulinemia and reiterated that iopofosine I‑131 has received multiple FDA regulatory designations (Breakthrough Therapy, multiple Orphan Drug, Rare Pediatric Disease, and two Fast Track designations) across cancer indications. The communication highlights the program’s alignment with expedited U.S. regulatory pathways as clinical development advances. (globenewswire.com)⁵
Conference
Major Conference Updates
Conference Information
  • 2026 Society of Hematologic Oncology (SOHO) Annual Meeting — Houston, Texas; September 9–12, 2026. (read more)
  • Sentiment: Momentum toward chemo-free and immunotherapy-optimized care across lymphoma, with frontline intensification in DLBCL, bispecific-based combinations in FL, and maturing real‑world CAR T implementation; biomarker work foreshadows risk-adapted pathways. (read more)
  • Theme 1: Frontline DLBCL Optimization Beyond R-CHOP
    • Significance: Positive “frontMIND” signals position immunotherapy add‑ons to challenge entrenched R-CHOP and complement POLARIX-era practice. (read more)
    • Mechanism insights / clinical impact: Adding tafasitamab (CD19 mAb) plus lenalidomide to R‑CHOP improved PFS (HR 0.75; 2‑yr PFS 71.1% vs 62.9%) with higher ctDNA MRD negativity (81.3% vs 66.7%); toxicity increased but discontinuations were similar. POLARIX adoption remains incomplete in real‑world data, underscoring room for new regimens. (read more)
    • Patient populations affected: Previously untreated high‑intermediate/high‑risk DLBCL/HGBL in frontMIND; frontline DLBCL broadly (Pola‑R‑CHP utilization variability). (read more)
  • Theme 2: Bispecific Antibodies Enable Chemo‑Free, Fixed‑Duration Care in Indolent FL
    • Significance: Epcoritamab (Epkinly) + R2 (EPCORE FL‑1) sets a new efficacy benchmark and accelerates shift to outpatient, time‑limited therapy. (read more)
    • Mechanism insights / clinical impact: CD3×CD20 engagement with R2 drove ORR 95% (vs 79%) and 79% risk reduction for progression/death; three‑step step‑up dosing cut CRS to 26% but infections/neutropenia increased, highlighting prophylaxis/IVIg considerations and delivery logistics. (read more)
    • Patient populations affected: Relapsed/refractory FL after ≥1 prior therapy; access constraints persist in community settings, prompting referrals to tertiary centers. (read more)
  • Theme 3: MCL—De‑Emphasizing ASCT and Scaling CAR T in Practice
    • Significance: TRIANGLE supports frontline strategies that omit ASCT; concurrently, real‑world “liso‑cel” experience validates efficacy and outpatient feasibility, guiding resource planning. (read more)
    • Mechanism insights / clinical impact: Ibrutinib‑based arms in TRIANGLE outperformed ASCT‑containing strategies; lisocabtagene maraleucel (liso‑cel; Breyanzi) produced ORR 89%/CR 79%, 6‑mo PFS 79%/OS 92%, with 39% treated outpatient and 2% 6‑mo NRM. (read more)
    • Patient populations affected: Frontline, transplant‑eligible MCL (TRIANGLE paradigm); BTK inhibitor–exposed R/R MCL candidates for CD19 CAR T. (read more)
  • Theme 4: Biomarker‑Informed Risk Adaptation (ctDNA, CXCR4)
    • Significance: MRD and chemokine‑axis biomarkers are moving from exploratory to decision‑support, informing sequencing of bispecifics, CAR T, and intensified frontline regimens. (read more)
    • Mechanism insights / clinical impact: End‑of‑treatment MRD negativity favored “frontMIND” combination; high CXCR4 expression predicted ~20% worse CAR T responses in a ~2,000‑patient analysis, nominating CXCR4 inhibition hypotheses. (read more)
    • Patient populations affected: High‑risk DLBCL in frontline and CAR T‑eligible LBCL subsets where biomarker‑guided triage could optimize modality choice. (read more)
  • Significance
    • Expected clinical or translational readouts: Additional bispecific data in DLBCL anticipated “in the next few months”; ctDNA/MRD analyses likely to expand across trials. (read more)
    • Regulatory or policy implications: Potential U.S. decision on “frontMIND” in early 2027; epcoritamab + R2 received Canadian approval for R/R FL on September 24, 2026. (read more)
    • Potential shifts in standard of care: Chemo‑free bispecific combinations in 2L+ FL; evolving frontline DLBCL beyond R‑CHOP; diminishing role of ASCT in MCL. (read more)
    • Strategic implications: Prioritize payer‑friendly, outpatient‑deliverable regimens (bispecifics, CAR T with streamlined monitoring); invest in MRD/CXCR4 testing pathways; prepare market education for frontline DLBCL portfolio positioning vs POLARIX. (read more)
Publications Related to Approved Drugs
A patient's experience with follicular lymphoma from diagnosis to cure: the life-changing impact of CAR T-cell therapy. This publication presents a patient's perspective on their journey with follicular lymphoma, detailing their experience through six lines of therapy before enrolling in the ZUMA-5 clinical trial. The patient achieved a complete and lasting remission with the CAR T-cell therapy axicabtagene ciloleucel, highlighting its potential as a curative treatment even after multiple relapses. ()
Indirect Comparison of the Efficacy of Zanubrutinib vs Ibrutinib and Acalabrutinib in Treatment-Naive Chronic Lymphocytic Leukemia: 6-Year Follow-Up. Based on an indirect comparison of three separate Phase 3 trials, this analysis suggests that zanubrutinib may offer sustained progression-free and overall survival benefits compared to ibrutinib and acalabrutinib for treatment-naive chronic lymphocytic leukemia. Zanubrutinib demonstrated a statistically significant improvement in progression-free survival over ibrutinib and showed positive trends toward improved outcomes compared to acalabrutinib at the 6-year mark. (, , )
Five-year follow-up of OPTIC: long-term efficacy, safety, and mutation analyses of ponatinib in chronic-phase chronic myeloid leukemia from a randomized phase 2 trial. The 5-year results from the OPTIC trial confirm the long-term clinical benefit of a response-based dosing strategy for ponatinib in patients with resistant chronic-phase chronic myeloid leukemia. Starting at a 45-mg dose and reducing to 15 mg upon response provided the highest rate of achieving ≤1% BCR::ABL1IS, particularly in patients with the T315I mutation, while maintaining a manageable long-term safety profile. ()
Asciminib monotherapy in patients with BCR::ABL1 T315I-mutated chronic-phase chronic myeloid leukemia: phase 1 trial final results. This final analysis of a Phase 1 trial confirms the long-term efficacy and safety of asciminib as a key treatment option for patients with T315I-mutated chronic-phase chronic myeloid leukemia. After a median exposure of 3.5 years, asciminib demonstrated durable major molecular responses, with over half of evaluable patients achieving this endpoint and a high rate of response maintenance, alongside a favorable safety profile with no new signals. ()
Exposure-Response Analyses to Inform the Optimal Epcoritamab Monotherapy Dosing Regimen in Relapsed or Refractory Follicular Lymphoma. This analysis supports an optimized 3-step step-up dosing regimen for epcoritamab in relapsed/refractory follicular lymphoma, confirming that a 48 mg full dose achieves a plateau in efficacy with a manageable safety profile. The optimized regimen, which includes prophylaxis, was shown to lower the frequency and severity of cytokine release syndrome while maintaining pharmacokinetic and B-cell depletion profiles similar to the 2-step regimen. ()
Efficacy of pacritinib versus momelotinib in patients with thrombocytopenic myelofibrosis: a matching-adjusted indirect treatment comparison. In a matching-adjusted indirect comparison for patients with thrombocytopenic myelofibrosis, pacritinib showed consistent, though not statistically significant, trends toward improved efficacy over momelotinib. The analysis indicated nominal benefits for pacritinib across endpoints including symptom score reduction, spleen volume reduction, transfusion independence, and overall survival. (, )
Decreased TXNRD1 is associated with resistance to tagraxofusp in blastic plasmacytoid dendritic cell neoplasms, as seen in phase II. This study identifies potential biomarkers of resistance to tagraxofusp in blastic plasmacytoid dendritic cell neoplasm (BPDCN) by analyzing samples from a Phase 2 trial. The findings suggest that lower expression of the enzyme TXNRD1 and the presence of truncating TET2 mutations in tumor cells are associated with a reduced response to the therapy. ()
New Publications Related to Drugs in Clinical Trial Development
Peripheral CD8⁺ T-cell clonality and NK-cell expansion mark early response to mosunetuzumab in indolent B-cell lymphoma. In a phase 2 trial, subcutaneous mosunetuzumab for untreated follicular or marginal zone lymphoma induced early immune changes, including clonal expansion of CD8+ T-cells and NK-cell activation. These responses were associated with early complete clinical response, identifying key biomarkers and providing a framework for strategies to enhance bispecific antibody efficacy. ()
Ultralow-Dose Interleukin 10-Expressing Chimeric Antigen Receptor T Cells in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Nonrandomized Clinical Trial. An ultralow dose of META 10-19, an IL-10 expressing CD19 CAR T-cell therapy, demonstrated a high objective response rate (92.3%) and complete remission rate (84.6%) in patients with relapsed/refractory DLBCL. The therapy showed promising antitumor activity with a manageable safety profile, warranting further investigation in larger cohorts. ()
Characterization of JNJ-80948543 a novel CD79bxCD20xCD3 trispecific antibody for B-cell non-Hodgkin lymphoma. The novel trispecific T-cell engager JNJ-80948543 targets both CD79b and CD20, demonstrating potent preclinical cytotoxicity against lymphoma cells with a favorable cytokine profile due to its low-affinity CD3 binding. This dual-antigen engagement may enhance tumor eradication and reduce antigen escape, supporting its ongoing clinical development for relapsed/refractory B-NHL. ()
A Randomized Phase II Study of Subcutaneous Mosunetuzumab in Combination With Polatuzumab Vedotin Compared With Rituximab Plus Polatuzumab Vedotin in Patients With Relapsed or Refractory Large B-Cell Lymphoma. In patients with relapsed/refractory large B-cell lymphoma, fixed-duration subcutaneous mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) demonstrated superior efficacy over rituximab plus polatuzumab vedotin (R-Pola), with a higher best objective response rate (77.5% vs. 50.0%) and significantly longer median progression-free survival (25.4 vs. 6.4 months). These findings, consistent with the Phase III SUNMO study, support Mosun-Pola as a highly effective regimen in this setting. ()
Vorinostat for graft-versus-host disease prevention in pediatric and young adult patients with hematologic malignancies. The addition of vorinostat to standard graft-versus-host disease (GVHD) prophylaxis in pediatric and young adult patients undergoing allogeneic HCT was safe and resulted in a low cumulative incidence of grade II-IV acute GVHD (14% at day +100). These promising results, supported by correlative studies showing on-target HDAC activity, endorse further randomized evaluation of this strategy. ()
Cost-effectiveness of Orca-T vs allo-HCT with conventional GVHD prophylaxis for the treatment of advanced hematologic malignancies in the United States. A cost-effectiveness model demonstrated that the allogeneic T-cell immunotherapy Orca-T is a dominant treatment strategy compared to conventional allo-HCT, as it was associated with both lower lifetime costs and higher quality-adjusted life-years. This high-value profile is driven by significant reductions in GVHD and infection-related healthcare burdens. ()
Venetoclax plus pediatric regimen in adolescents and adults with Ph-negative acute lymphoblastic leukemia. In a prospective phase 2 study, adding venetoclax to a first-line pediatric-inspired chemotherapy regimen for adolescents and adults with newly diagnosed Philadelphia chromosome-negative ALL significantly improved measurable residual disease negativity rates and survival outcomes. The combination had a manageable safety profile and showed superior survival compared to historical controls, suggesting a new potential standard of care. ()
Englumafusp alfa plus glofitamab in B cell non-Hodgkin lymphoma: a phase 1 trial. The combination of englumafusp alfa, a CD19-4-1BBL co-stimulatory molecule, with the T-cell engaging bispecific antibody glofitamab showed encouraging efficacy in patients with relapsed or refractory B-NHL, achieving an overall response rate of 68.7% in those with aggressive disease. This off-the-shelf therapy demonstrated a safety profile consistent with glofitamab monotherapy, supporting its continued development. ()
Safe Accelerated Venetoclax Escalation: a phase 1b study of obinutuzumab plus venetoclax with daily ramp-up in CLL. This study successfully demonstrated the safety and feasibility of an accelerated 5-day inpatient venetoclax dose ramp-up in combination with obinutuzumab for patients with CLL, including those at high risk for tumor lysis syndrome (TLS). This approach, which resulted in no clinical TLS and a 78% overall response rate at 3 months, offers a strategy to simplify treatment initiation in experienced centers. ()
A Randomized Phase II Study of Subcutaneous Mosunetuzumab in Combination With Polatuzumab Vedotin Compared With Rituximab Plus Polatuzumab Vedotin in Patients With Relapsed or Refractory Large B-Cell Lymphoma. In patients with relapsed/refractory large B-cell lymphoma, fixed-duration subcutaneous mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) demonstrated superior efficacy over rituximab plus polatuzumab vedotin (R-Pola), with a higher best objective response rate (77.5% vs. 50.0%) and significantly longer median progression-free survival (25.4 vs. 6.4 months). These findings, consistent with the Phase III SUNMO study, support Mosun-Pola as a highly effective regimen in this setting. ()
CAR T-cell therapy as a definitive consolidation for older adults with B-ALL in first complete remission. A phase 1 study assessing CD19 CAR T-cell therapy as a consolidation treatment for older adults with B-ALL in first complete remission found the approach to be safe and well-tolerated, with no dose-limiting toxicities. The therapy potentially extended remission, with an estimated 18-month event-free survival of 84%, supporting further investigation of early CAR T-cell use in B-ALL. ()
Venetoclax plus Inotuzumab Ozogamicin for Relapsed and Refractory Acute Lymphoblastic Leukemia. The combination of venetoclax and the CD22 antibody-drug conjugate inotuzumab ozogamicin proved to be a safe and highly effective regimen for adults with relapsed/refractory B-ALL/LBL. This novel pairing produced frequent and durable MRD-negative remissions, with a 95.5% complete remission rate and a two-year overall survival of 48%, offering a promising bridge to transplant. ()
Outcomes From the Multicenter ACCRU-LY-1804/CARiBOU TRIAL (Cytarabine, Acalabrutinib and Rituximab Integrated With Bortezomib-Based Outpatient Therapy) in 1st Line Mantle Cell Lymphoma. The CARiBOU trial tested a multi-targeted, outpatient first-line regimen for mantle cell lymphoma, achieving a 90% complete metabolic response rate and high rates of undetectable measurable residual disease (79% at a 10-6 threshold). This efficient six-cycle regimen, combining cytarabine, acalabrutinib, and VR-CAP, demonstrates high efficacy with manageable toxicities and allows for flexible, MRD-guided consolidation decisions. ()
Venetoclax added to dose-adjusted EPOCH-R for newly diagnosed double-hit lymphomas: phase 2 results from ALLIANCE A051701, an open-label, randomised, controlled, phase 2-3 trial. In the ALLIANCE A051701 trial for newly diagnosed double-hit lymphoma, the addition of the BCL2-inhibitor venetoclax to standard DA-EPOCH-R chemoimmunotherapy did not improve progression-free survival and resulted in excess on-treatment mortality, prompting early closure of this study arm. The outcomes in the DA-EPOCH-R control group now serve as a crucial benchmark for future clinical trials in this aggressive lymphoma subtype. ()
Exposure-Response Analyses to Inform the Optimal Epcoritamab Monotherapy Dosing Regimen in Relapsed or Refractory Follicular Lymphoma. Pharmacokinetic and exposure-response analyses for epcoritamab in relapsed/refractory follicular lymphoma confirmed that the 48 mg full dose provides optimal efficacy, with response rates potentially plateauing at this exposure level. A 3-step step-up dosing regimen was shown to lower the frequency and severity of cytokine release syndrome without compromising B-cell depletion, supporting its use as the recommended regimen. ()
RENOIR phase 3 rituximab-lenalidomide vs rituximab as maintenance treatment in relapsed/refractory follicular lymphoma. The RENOIR phase 3 trial found that adding lenalidomide to rituximab (R2) maintenance did not significantly improve 2-year progression-free survival compared to rituximab alone in older patients with relapsed/refractory follicular lymphoma. A subgroup analysis suggested a potential benefit in patients younger than 70, but increased toxicity warrants careful consideration of the benefit-risk profile in older individuals. ()
CAR T-cell therapy as a definitive consolidation for older adults with B-ALL in first complete remission. A phase 1 study assessing CD19 CAR T-cell therapy as a consolidation treatment for older adults with B-ALL in first complete remission found the approach to be safe and well-tolerated, with no dose-limiting toxicities. The therapy potentially extended remission, with an estimated 18-month event-free survival of 84%, supporting further investigation of early CAR T-cell use in B-ALL. ()
Characterization of JNJ-80948543 a novel CD79bxCD20xCD3 trispecific antibody for B-cell non-Hodgkin lymphoma. The novel trispecific T-cell engager JNJ-80948543 targets both CD79b and CD20, demonstrating potent preclinical cytotoxicity against lymphoma cells with a favorable cytokine profile due to its low-affinity CD3 binding. This dual-antigen engagement may enhance tumor eradication and reduce antigen escape, supporting its ongoing clinical development for relapsed/refractory B-NHL. ()
Blinatumomab for Replacing Chemotherapy in Pediatric Acute Lymphoblastic Leukemia. In children with newly diagnosed high-risk B-cell ALL, replacing two cycles of highly toxic conventional chemotherapy with the bispecific T-cell engager blinatumomab resulted in significantly higher 4-year event-free survival (83.0% vs. 70.3%). This approach also led to a markedly lower incidence of treatment-related infections and life-threatening adverse events, establishing it as a superior and safer therapeutic option. ()
Epcoritamab with rituximab and lenalidomide as first-line treatment for follicular lymphoma (EPCORE NHL-2): an open-label, multicentre, phase 1/2 b trial. The chemotherapy-free, first-line combination of subcutaneous epcoritamab with rituximab and lenalidomide demonstrated high and durable activity in follicular lymphoma, achieving a 95% overall response rate with a median follow-up of nearly 36 months. Despite a 7% rate of treatment-related deaths, this regimen shows promise for producing deep responses and warrants further analysis. ()
Adjuvant alectinib versus chemotherapy in resected ALK-positive non-small-cell lung cancer (ALINA): health-related quality-of-life and safety outcomes from a randomised, open-label, phase 3 trial. In the ALINA trial for resected ALK-positive NSCLC, adjuvant alectinib not only improved disease-free survival but also demonstrated a manageable safety profile and maintained or improved health-related quality of life over two years. These data support adjuvant alectinib as an important new standard of care, offering a better-tolerated and more effective option than platinum-based chemotherapy. ()
A phase 1, first-in-human study of safimaltib, a MALT1 inhibitor, in B-lymphocytic malignancies. The first-in-human study of the MALT1 protease inhibitor safimaltib established proof-of-principle activity in relapsed/refractory B-cell lymphomas, with an objective response rate of 28.8%. Despite off-target hyperbilirubinemia, the on-target activity and notable responses in patients with B-cell-receptor pathway mutations suggest MALT1 is a feasible therapeutic target requiring further investigation. ()
Decade-long persistence of CD19 CAR T cells in B cell lymphomas. This landmark study reports the persistence of functional anti-CD19 CAR T-cells for up to a decade in patients with non-Hodgkin lymphoma, with some maintaining B-cell aplasia, which indicates sustained activity. Long-term persisting CAR T-cells evolved into a predominant double-negative, effector-memory-like phenotype, providing key insights into the biology of durable remissions following CAR T-cell therapy. ()
Five-year survival outcomes of lisocabtagene maraleucel in R/R LBCL from the TRANSCEND NHL 001 study. Five-year follow-up from the TRANSCEND NHL 001 study confirms the curative potential of lisocabtagene maraleucel (liso-cel) in patients with relapsed/refractory large B-cell lymphoma, demonstrating an estimated 5-year overall survival of 38%. The data show durable survival benefits with no new long-term safety signals and a 5-year disease-specific survival of 52%. ()
A Phase 1 Trial of Duvelisib and Oral Azacitidine in Relapsed/Refractory T-Cell Lymphoma. The combination of the PI3K inhibitor duvelisib and oral azacitidine showed a manageable safety profile and encouraging clinical activity (46% ORR) in relapsed/refractory T-cell lymphoma. Notably, all four evaluable patients with a T-follicular-helper (TFH) phenotype achieved a complete response, suggesting this combination warrants further randomized evaluation, particularly in this subtype. ()
A randomized, multicenter phase II trial to compare prophylaxis of graft versus host disease with tacrolimus and mycophenolate mofetil versus ruxolitinib after post-transplant cyclophosphamide. A calcineurin-free GVHD prophylaxis regimen using post-transplant cyclophosphamide and ruxolitinib (PTCy-Ruxo) was noninferior to the standard PTCy-Tac-MMF regimen in preventing acute GVHD after allogeneic HCT. The PTCy-Ruxo combination also demonstrated a superior safety profile, with significantly lower rates of kidney injury and endothelial complications, making it a promising alternative. ()
ENCERT: A Multisite Phase 1 Trial Using Everolimus in Combination With Nelarabine, Cyclophosphamide, and Etoposide in Relapsed T-Cell Lymphoblastic Leukemia/Lymphoma. The combination of the mTOR inhibitor everolimus with NEC chemotherapy was safe and demonstrated a high overall response rate of 75% in children and young adults with relapsed/refractory T-ALL/T-LL. This efficacy, particularly the 100% response rate in the T-ALL cohort, supports further evaluation of this combination as an effective bridge to transplant. ()
A prospective, multi-center, phase IV clinical study to assess the safety and clinical outcome of acalabrutinib in Indian adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma or relapsed/refractory mantle cell lymphoma. In a real-world setting in India, acalabrutinib demonstrated a safety profile consistent with global trials for patients with CLL/SLL and relapsed/refractory MCL, with no new safety signals identified. The study confirmed encouraging clinical outcomes, achieving objective response rates of 62% in the CLL/SLL cohort and 36% in the MCL cohort. ()
Lineage Plasticity-Mediated Resistance to CD7-Directed CAR-T Therapy in Relapsed/Refractory T-ALL/LBL. While recyclable CD7 CAR-T cell therapy showed promising efficacy and robust expansion in patients with relapsed/refractory T-ALL/LBL, this study identified lineage switching as a potential mechanism of resistance, particularly in patients with an ETP-immunophenotype. This finding highlights an under-recognized hurdle for CD7-directed therapies that warrants further exploration. ()
Umbilical cord blood-derived CAR-NK cells: an emerging off-the-shelf platform for cancer immunotherapy. Umbilical cord blood (UCB)-derived CAR-NK cells represent a compelling "off-the-shelf" immunotherapy platform, having achieved a 64% complete remission rate in a phase I/II trial for B-cell malignancies with no observed GVHD or neurotoxicity. However, the limited in vivo persistence of these cells was identified as a principal barrier to durable responses that needs to be addressed for future development. ()
Population pharmacokinetic analysis of pirtobrutinib, a non-covalent BTK inhibitor, in patients with hematological malignancies from the Phase 1/2 BRUIN study. A population pharmacokinetic analysis of the non-covalent BTK inhibitor pirtobrutinib from the BRUIN study confirmed that the recommended 200 mg once-daily dose provides extensive and durable target engagement. The analysis showed that over 96% of patients are expected to exceed 90% BTK inhibition across the dosing interval, supporting this dose without adjustments for patient-specific factors like body weight or renal function. ()
Unusually long remission in two patients with follicular lymphoma receiving immunomodulating therapeutic cancer vaccines. Long-term follow-up of a phase I trial of an immune-modulating vaccine targeting PD-L1 and PD-L2 in follicular lymphoma revealed two patients with unusually long remissions of five and 6.5 years. These patients demonstrated persistent, functionally active vaccine-specific T-cell responses years after vaccination, suggesting a potential disease-modifying effect of this therapeutic strategy. ()
Validation of the newly introduced Deauville score 5a for patients treated for advanced-stage classic Hodgkin lymphoma. This study validates the prognostic value of the refined Deauville score in advanced-stage classical Hodgkin lymphoma, demonstrating that the new subcategory DS5a (high uptake without new lesions) successfully identifies a small, high-risk patient group at interim PET. This refinement supports improved risk assessment and treatment adaptation based on quantitative imaging biomarkers. ()
Updated Integrated Safety Analysis of Ritlecitinib up to ~ 5 Years in Patients with Alopecia Areata from the ALLEGRO Clinical Trial Program. An updated integrated safety analysis of the ALLEGRO program confirms that long-term ritlecitinib treatment (up to ~5 years) is generally well-tolerated in patients aged 12 and older with alopecia areata. The safety profile remained consistent with previous reports, with low incidence rates of serious adverse events, opportunistic infections, and malignancies. ()
Long-Term Efficacy and Safety of Ritlecitinib in Adults and Adolescents with Alopecia Areata: 3-Year Results from the ALLEGRO Phase 2b/3 and ALLEGRO-LT Phase 3 Clinical Studies. Ritlecitinib 50 mg demonstrated durable and clinically meaningful efficacy for up to 3 years in patients with severe alopecia areata, with over 65% of patients achieving a Severity of Alopecia Tool (SALT) score ≤ 20. The long-term safety profile was consistent with previous findings, supporting its continued use in this patient population. ()
First-line ibrutinib plus venetoclax for nonblastoid mantle cell lymphoma in patients ≥65 years old or with TP53 mutations. The first-line, chemotherapy-free combination of ibrutinib and venetoclax showed promising efficacy in older (≥65 years) or TP53-mutated patients with nonblastoid mantle cell lymphoma, achieving a 69% complete response rate and a median progression-free survival of 40.2 months. This regimen offers a potential new standard of care with durable remissions for this high-risk population. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in lymphoma updated from 2026-09-01 to 2026-09-30:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation2-1---3
Not Yet Recruiting431513-26
Recruiting4330704291177
Available-------
Approved for Marketing-------
Active, Not Recruiting292143-142109
Completed312---6
Total81551315463321
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
bleximenib, 14C-bleximenib NCT07295951 COMPLETED An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants With Acute Leukemia 2026-07-21
Indocyanine Green NCT04084067 COMPLETED Indocyanine Green (ICG) Guided Tumor Resection 2026-08-26
: Lisocabtagene Maraleucel, Cyclophosphamide, Polymer-conjugated IL-15 Receptor Agonist NKTR-255, Fludarabine NCT05359211 COMPLETED A Phase Ib Open-Label Study Evaluating the Safety and Efficacy of NKTR-255 in Combination With CD19-Directed CAR-T Cell Therapy in Patients With Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) 2026-09-04
Autologous Anti-CD19 CAR-expressing T Lymphocytes, Cyclophosphamide, Fludarabine NCT05707273 ACTIVE_NOT_RECRUITING A Pilot Study of CD19-Specific Car T Cells as Consolidation for Older Adults With Acute Lymphoblastic Leukemia in First Remission 2026-09-22
JNJ-75348780, JNJ-80948543, JNJ-87801493 NCT06139406 ACTIVE_NOT_RECRUITING A Phase 1, First-in-human Study of JNJ-87801493 in Combination With CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies (NHLs) 2026-09-30
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Gabapentin NCT05064319 COMPLETED Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders: A Randomized, Double-blind, Placebo-controlled, Parallel-group, MRI Study 2026-07-31
CD19/CD22 bispecific CAR-T cells NCT07461831 COMPLETED CD19/ CD22 Bispecific CAR-T Cell Therapy for Relapsed/ Refractory Large B-cell Lymphoma: A Prospective, Single-Arm, Single-Center, Phase 2 Trial 2026-09-29
[No Drug Info] NCT06052826 RECRUITING Geriatric (G) Assessment Guided Optimization (O) to Accelerate Functional Recovery After Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Patients 60 Years and Older With B-Cell Non-Hodgkin Lymphoma or Multiple Myeloma (GOCART) 2026-10-05
Cyclophosphamide, Prednisone, Doxorubicin, Rituximab, Tocilizumab, Vincristine, Glofitamab NCT04980222 ACTIVE_NOT_RECRUITING A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma 2026-10-15
vincristine, dacarbazine, etoposide, cyclophosphamide, doxorubicin, prednisone/prednisolone, : pembrolizumab, bleomycin, vinblastine NCT03407144 ACTIVE_NOT_RECRUITING An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667) 2026-11-06
Cyclophosphamide, Vinblastine, Etoposide, Dacarbazine, Adriamycin, Brentuximab Vedotin NCT03517137 ACTIVE_NOT_RECRUITING Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study 2026-11-16
Glofitamab, MEN1703 NCT06534437 RECRUITING An Open Label, Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination With Glofitamab in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma 2026-12
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
No phase 3 trials completing within the next three months.
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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