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LymphomaJune 2026
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Lymphoma — Monthly Compass
Jun 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
    • On June 30, 2026, the FDA approved Orca Bio’s Tregzi—an allogeneic regulatory T cell–based immunotherapy with HSPC and T cells‑vldq—for use in matched donor hematopoietic stem cell transplantation in adults with hematological malignancies, based on Precision‑T demonstrating improved chronic graft‑versus‑host disease–free survival.
    • Frontline standards in high‑risk DLBCL are poised to shift as tafasitamab/lenalidomide + R‑CHOP could challenge pola‑R‑CHP and bsAb‑ or ADC‑anchored regimens may displace platinum‑based salvage in second line.
  • Important Drug Publication Updates
    • The Lancet published the phase 3 frontMIND trial on June 20, 2026, reporting that tafasitamab + lenalidomide + R‑CHOP reduced the risk of progression or death by approximately 25% across molecular subtypes in high‑risk newly diagnosed DLBCL/HGBL and supporting filing activities for this frontline triplet.
  • Key Clinical Development Updates
    • The FDA accepted Genentech’s sBLA for subcutaneous mosunetuzumab (Lunsumio VELO) plus polatuzumab vedotin in relapsed/refractory large B‑cell lymphoma after at least one prior line with a PDUFA date of February 9, 2027, while ADC Therapeutics scheduled a pre‑sBLA FDA meeting for August 2026 and targets a Q4 2026 sBLA submission for ZYNLONTA + rituximab in relapsed/refractory DLBCL.
    • Cell therapy momentum continued as Imugene’s azer‑cel received FDA Fast Track for relapsed/refractory CLL/SLL and MZL, Caribou’s vispa‑cel carries RMAT, Fast Track, and Orphan designations with FDA alignment on the randomized pivotal ANTLER‑3 phase 3 in second‑line LBCL, and Lyell’s ronde‑cel advances in the pivotal PiNACLE and PiNACLE‑H2H trials with a BLA planned for 2027.
  • Important Clinical Trial Publications
    • EPCORE NHL‑6 showed that subcutaneous epcoritamab in 2L+ relapsed/refractory DLBCL can transition to outpatient administration after early dosing, supporting ambulatory care pathways contingent on CRS/ICANS management.
    • EHA translational analyses associated reduced CD20 expression and intratumoral T‑cell dynamics with progression under epcoritamab in DLBCL/FL.
  • Key Conference Updates
    • At ASCO 2026 and EHA 2026, lymphoma presentations highlighted bispecific antibodies moving earlier with fixed‑duration strategies, targeted combinations improving high‑risk frontline outcomes, renewed ADC momentum, and pragmatic outpatient adoption signals including patient‑driven schedule preferences.
  • Emerging Themes & Macro-Trends
    • CD20×CD3 bispecifics are rapidly expanding into first‑line and elderly/unfit segments with step‑up dosing to manage CRS and fixed‑duration regimens enabling treatment‑free intervals, while fixed‑duration glofitamab in mantle cell lymphoma extends T‑cell–redirecting activity beyond late‑line salvage.
    • ADC competitiveness is rebounding as LOTIS‑5 topline durability for loncastuximab tesirine + rituximab and first‑in‑class ROR1‑targeted zilovertamab vedotin open chemo‑free or hybrid options for transplant/CAR‑T‑ineligible relapsed/refractory DLBCL and require differentiation versus T‑cell engagers by efficacy, convenience, and safety.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • The FDA has approved Tregzi (allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq) by Orca Bio for use in matched donor hematopoietic stem cell transplantation in adults with hematological malignancies. This approval is based on the Precision-T trial, which demonstrated improved chronic graft-versus-host disease-free survival. The therapy aims for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGHVD)-free survival.¹ (read more)
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Lyell Immunopharma announced EHA 2026 presentations for rondecabtagene autoleucel (ronde-cel) in relapsed/refractory large B‑cell lymphoma and stated the program is being evaluated in two pivotal trials (PiNACLE and PiNACLE‑H2H), with a subsequent Biologics License Application (BLA) submission planned for 2027. The update signals an active U.S. regulatory trajectory with BLA timing articulated. ¹ (read more)
  • Imugene reported that the FDA granted Fast Track designation to its allogeneic CD19 CAR T azer‑cel (azercabtagene zapreleucel) for two lymphoma-related indications: relapsed/refractory CLL/SLL and relapsed/refractory marginal zone lymphoma (MZL). The company noted Fast Track enables more frequent FDA engagement, rolling review, and potential eligibility for Accelerated Approval and Priority Review. ² (read more)
  • Caribou Biosciences presented long‑term data for vispacabtagene regedleucel (vispa‑cel; off‑the‑shelf anti‑CD19 CAR T) in B‑cell non‑Hodgkin lymphoma and highlighted that the FDA has granted RMAT, Fast Track, and Orphan Drug designations for B‑NHL. Caribou also disclosed alignment with FDA on the design of ANTLER‑3, a randomized, pivotal phase 3 trial in second‑line LBCL. ³ (read more)
  • Incyte reported positive phase 3 frontMIND results for tafasitamab (Monjuvi)/lenalidomide plus R‑CHOP in previously untreated high‑risk DLBCL/HGBL and said the data support global regulatory applications. The company also reiterated Monjuvi’s existing U.S. accelerated approval in combination with lenalidomide for relapsed/refractory DLBCL, underscoring ongoing FDA‑related context for the program. ⁴ (read more)
  • Genentech announced FDA acceptance of its sBLA for subcutaneous Lunsumio VELO (mosunetuzumab‑axgb) plus Polivy (polatuzumab vedotin) for adults with relapsed/refractory large B‑cell lymphoma after at least one prior line of therapy. The company disclosed a PDUFA decision date of February 9, 2027. ⁵ (read more)
  • ADC Therapeutics disclosed a strategic reorganization and said it has a pre‑sBLA meeting with the FDA scheduled for August 2026 to discuss ZYNLONTA (loncastuximab tesirine) plus rituximab in relapsed/refractory DLBCL, with an sBLA submission expected in Q4 2026. The company emphasized preparation for upcoming FDA regulatory milestones. ⁶ (read more)
Conference
Major Conference Updates
Conference Information
  • 2026 ASCO Annual Meeting, Chicago, Illinois, May 29–June 2, 2026; EHA2026 Congress, Stockholm, Sweden, June 11–14, 2026.
  • Overall sentiment: Lymphoma data in June 2026 emphasized bispecific antibodies moving earlier, targeted combinations improving high‑risk frontline outcomes, and renewed ADC momentum, alongside pragmatic adoption signals (outpatient use, patient‑driven preferences). (read more)
  • Theme 1: Bispecifics Advance to Earlier Lines and Fixed-Duration Use
    • Significance: Rapid encroachment of CD20×CD3 agents into 1L/elderly‑unfit segments indicates a potential alternative to intensive chemoimmunotherapy in select patients. (read more)
    • Mechanism insights / clinical impact: 1L odronextamab + CHOP (OLYMPIA‑3) and fixed‑duration glofitamab in MCL demonstrate T‑cell–redirecting activity beyond late‑line salvage, with manageable CRS via step‑up dosing; fixed‑duration designs support treatment‑free intervals. (read more)
    • Patient populations affected: Previously untreated DLBCL (including elderly/unfit) and R/R MCL; potential expansion to broader high‑risk cohorts. (read more)
  • Theme 2: Targeted Combinations Outperform Legacy Chemotherapy Backbones
    • Significance: Combinations pairing immunotherapies with chemo/ADC backbones are delivering clinically meaningful PFS advantages, positioning for frontline and early‑relapse practice change. (read more)
    • Mechanism insights / clinical impact: frontMIND (tafasitamab + lenalidomide + R‑CHOP) reduced risk of progression/death by ~25% across molecular subtypes; mosunetuzumab + polatuzumab vedotin (SUNMO) showed activity vs R‑GemOx and informative 2L vs 3L subgroup readouts; epcoritamab + CIT in ASCT‑eligible R/R LBCL supports chemo‑backbone synergy. (read more)
    • Patient populations affected: High‑intermediate/high‑risk newly diagnosed DLBCL/HGBL; transplant‑eligible early‑relapse LBCL; 2L settings seeking CAR‑T alternatives. (read more)
  • Theme 3: ADC Momentum and Portfolio Differentiation in R/R DLBCL
    • Significance: Positive LOTIS‑5 topline and ongoing ROR1‑ADC programs revive ADC competitiveness vs bispecifics, enabling chemo‑free or hybrid options. (read more)
    • Mechanism insights / clinical impact: CD19‑targeting loncastuximab tesirine (pyrrolobenzodiazepine payload) with rituximab showed durable CR fraction at 24 months; ROR1‑directed zilovertamab vedotin highlights a first‑in‑class avenue potentially complementary to CD20/CD19 approaches. (read more)
    • Patient populations affected: Transplant/CAR‑T‑ineligible R/R DLBCL and high‑risk subsets where toxicity and logistics favor outpatient ADC use. (read more)
  • Theme 4: Real‑World Adoption, Outpatient Feasibility, and Resistance Biology
    • Significance: Implementation data (outpatient dosing, patient‑preferred schedules) and biomarker signals will shape access, monitoring, and sequencing. (read more)
    • Mechanism insights / clinical impact: EPCORE NHL‑6 supports outpatient SC epcoritamab after early dosing; real‑world FL outcomes with mosun/epcoritamab contextualize efficacy; EHA translational data link reduced CD20 expression and intratumoral T‑cell dynamics to progression under epcoritamab. (read more)
    • Patient populations affected: R/R DLBCL and FL in community settings; centers optimizing CRS/ICANS pathways to enable ambulatory care. (read more)
  • Significance
    • Expected clinical or translational readouts: Mature SUNMO and OLYMPIA‑3 results (response durability, OS); additional biomarker analyses (CD20 modulation, T‑cell infiltration) to refine bsAb sequencing. (ascopubs.org) (read more)
    • Regulatory or policy implications: frontMIND outcomes plus Lancet publication support filing activities for tafasitamab + lenalidomide + R‑CHOP in 1L high‑risk DLBCL. (read more)
    • Potential shifts in standard of care: Frontline triplet could challenge pola‑R‑CHP in high‑risk DLBCL; bsAb‑ and ADC‑anchored regimens may displace platinum‑based salvage in 2L. (read more)
    • Strategic implications: Prioritize bsAb combinations and fixed‑duration designs, invest in outpatient infrastructure/CRS mitigation, and differentiate ADCs (payload/target) versus T‑cell engagers by efficacy, convenience, and safety. (ascopubs.org) (read more)
Publications Related to Approved Drugs
Phase 3
lenalidomide
Lenalidomide Plus Rituximab for Relapsed/Refractory Indolent Non-Hodgkin Lymphoma: 5-Year Follow-Up and Subgroup Analyses From the Phase III AUGMENT Trial. With a median follow-up of over five years, the AUGMENT trial's long-term data confirms that the combination of lenalidomide and rituximab (R²) provides a sustained improvement in both progression-free and overall survival compared to rituximab with placebo. These findings solidify R² as a standard of care for patients with relapsed or refractory indolent non-Hodgkin lymphoma, including those aged 70 and older. ()
Phase 3
zanubrutinib
Indirect Comparison of the Efficacy of Zanubrutinib vs Ibrutinib and Acalabrutinib in Treatment-Naive Chronic Lymphocytic Leukemia: 6-Year Follow-Up. This indirect comparison of three pivotal Phase 3 trials (SEQUOIA, ELEVATE-TN, RESONATE-2) suggests that zanubrutinib may offer sustained progression-free and overall survival benefits compared to ibrutinib and acalabrutinib in treatment-naive CLL. At the 72-month landmark, zanubrutinib demonstrated significantly higher rates of both PFS and OS versus the other two BTK inhibitors. ()
Phase 3
isatuximab
Isatuximab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma: dynamics of MRD negativity in the IMROZ study. In the Phase 3 IMROZ study for transplant-ineligible newly diagnosed multiple myeloma, the quadruplet therapy Isa-VRd led to significantly deeper and more sustained rates of minimal residual disease (MRD) negativity compared to the VRd triplet. This benefit was observed across all time points up to 60 months and in key subgroups, further establishing Isa-VRd as a standard of care for this patient population. ()
Phase 3
quizartinib
Quizartinib for patients with newly diagnosed FLT3-ITD-positive AML who received maintenance therapy in QuANTUM-First. Post-hoc analysis of the Phase 3 QuANTUM-First trial shows that for patients with newly diagnosed FLT3-ITD-positive AML who did not undergo transplant, quizartinib maintenance therapy provided a significant overall survival benefit. This effect was particularly pronounced in patients who were MRD-negative at the start of maintenance, suggesting that for some, quizartinib maintenance may eliminate the need for allogeneic hematopoietic cell transplantation. ()
Phase 3
asciminib
Asciminib Provides Better Efficacy and Favorable Safety and Tolerability Against Investigator-Selected Tyrosine Kinase Inhibitors in East Asian Patients With Newly Diagnosed Chronic Myeloid Leukemia: Results From a Subgroup Analysis of the Pivotal ASC4FIRST Study. A subgroup analysis of the pivotal Phase 3 ASC4FIRST trial demonstrated that asciminib has superior efficacy and a more favorable safety profile compared to investigator-selected standard-of-care TKIs in East Asian patients with newly diagnosed CML-CP. These results are consistent with the global study population and support the use of asciminib as a first-line treatment option for this disease. ()
Phase 2
elranatamab-bcmm
Comparison of Patient-Reported Outcomes for Elranatamab in MagnetisMM-3 Versus Real-World Physician Choice of Therapy for Triple-Class Refractory Multiple Myeloma. Patients with triple-class refractory multiple myeloma treated with elranatamab in the MagnetisMM-3 trial reported similar or greater improvements in quality of life, disease symptoms, and overall health status over a six-month period compared to patients receiving real-world physician's choice of therapy. These findings highlight the clinical benefit of elranatamab from the patient's perspective in a heavily pretreated population. ()
PHASE1, PHASE2
cedazuridine and decitabine
All-Oral Treatment of Newly Diagnosed Acute Myeloid Leukemia. The Phase 1/2 ASCERTAIN-V trial demonstrated that an all-oral combination of decitabine-cedazuridine plus venetoclax is an effective regimen for newly diagnosed AML patients ineligible for intensive chemotherapy, achieving a complete response in 47% of patients. This all-oral treatment provides a significant survival benefit with a median overall survival of 15.5 months and offers a less burdensome alternative to parenteral therapies. ()
PHASE1, PHASE2
tagraxofusp
Tagraxofusp in adult blastic plasmacytoid dendritic cell neoplasm: clinical trials and real-world outcomes: a systematic review. This systematic review of 27 studies, including the pivotal trial, confirms that tagraxofusp consistently induces high remission rates (ORR 65%-90%) in adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN) across both clinical trial and real-world settings. The analysis underscores that long-term survival is strongly dependent on successfully bridging patients to allogeneic hematopoietic stem cell transplantation following remission. ()
Phase 1
teclistamab
Longitudinal mechanisms of response, resistance and relapse to teclistamab in multiple myeloma: results from MajesTEC-1. In the MajesTEC-1 trial, longitudinal immune profiling revealed that response to teclistamab is associated with T-cell activation, while non-response is linked to persistent T-cell dysfunction and higher levels of immunosuppressive regulatory T-cells. Relapse was characterized by T-cell impairment and a reduction in BCMA receptor density on tumor cells, providing key insights to optimize future T-cell and bispecific antibody strategies. ()
Phase 3
daratumumab
FDG-PET medullary total tumor volume highlights high-risk patients with newly diagnosed multiple myeloma in CASSIOPEIA trial. Analysis from the CASSIOPET companion study to the Phase 3 CASSIOPEIA trial established that medullary total metabolic tumor volume (mTMTV), a baseline PET/CT-based parameter, is a strong and independent prognostic factor for both progression-free and overall survival in newly diagnosed multiple myeloma patients. This marker is complementary to the R-ISS staging system and helps refine risk stratification for patients receiving anti-CD38-based therapy. ()
Phase 2
avapritinib
Avapritinib improves cutaneous involvement in patients with indolent systemic mastocytosis: Results from the randomized, phase 2, interventional PIONEER study. In the Phase 2 PIONEER study, treatment with the KIT D816V inhibitor avapritinib led to significant improvements in the dermatologic symptoms of indolent systemic mastocytosis compared to placebo. Patients receiving avapritinib experienced a marked reduction in skin lesion size, normalization of lesion color, and a decrease in skin mast cell burden, demonstrating its efficacy in managing the cutaneous manifestations of the disease. ()
Phase 3
nelarabine
Homeodomain-driven oncogenic diversion to a γδTCR phenotype in T-cell acute lymphoblastic leukemia. This comprehensive analysis of T-ALL cases, including from the AALL0434 trial, delineates two distinct subtypes of γδTCR+ T-ALL, revealing significant developmental heterogeneity. One subtype, termed bona fide γδ T-ALL, is associated with a poor initial response to chemotherapy but shows sensitivity to the BCL2 inhibitor venetoclax, suggesting a potential targeted therapeutic strategy for this high-risk group. ()
Phase 3
momelotinib
Efficacy of pacritinib versus momelotinib in patients with thrombocytopenic myelofibrosis: a matching-adjusted indirect treatment comparison. This matching-adjusted indirect comparison of data from Phase 3 trials (PERSIST-2, MOMENTUM, SIMPLIFY-1) for patients with thrombocytopenic myelofibrosis showed consistent, though not statistically significant, trends favoring pacritinib over momelotinib. The analysis indicated nominal benefits for pacritinib across endpoints including symptom reduction, spleen volume reduction, and overall survival. ()
New Publications Related to Drugs in Clinical Trial Development
Phase 1
Phase 1 Trial of BCL-2 Inhibitor Lisaftoclax (APG-2575) in Chinese Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Other Non-Hodgkin Lymphomas. The novel BCL-2 inhibitor lisaftoclax (APG-2575) demonstrated a manageable safety profile and significant antitumor activity in Chinese patients with relapsed/refractory CLL/SLL and other NHLs. The therapy induced durable responses, particularly in CLL/SLL (ORR 71.4%) and MCL (ORR 50.0%), without reaching a maximum tolerated dose. ()
Phase 3
Efficacy and safety of subcutaneous mosunetuzumab plus polatuzumab vedotin in patients with relapsed/refractory large B-cell lymphoma: Japan subgroup analysis of the phase III SUNMO trial. A Japan subgroup analysis of the Phase III SUNMO trial showed that subcutaneous mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) resulted in a 100% overall response rate and significantly prolonged progression-free survival compared to R-GemOx in patients with R/R LBCL. The safety profile was manageable and consistent with the overall study population, supporting Mosun-Pola as a new treatment option. ()
PHASE1, PHASE2
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 a Phase II study, fixed-duration subcutaneous mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) demonstrated superior efficacy over rituximab plus polatuzumab vedotin (R-Pola) in patients with R/R LBCL, with a higher ORR (77.5% vs. 50.0%) and significantly longer median PFS (25.4 vs. 6.4 months). These findings align with the positive results from the larger Phase III SUNMO study. ()
PHASE1, PHASE2
Tumor burden-guided dosing contributes to mitigation of immunotoxicities following treatment with obecabtagene autoleucel in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia. The FELIX trial demonstrated that a tumor burden-guided, split-dosing strategy for obecabtagene autoleucel (obe-cel) in adult R/R B-ALL mitigates severe immunotoxicities like CRS and ICANS while maintaining high remission rates (73-85%). This approach suggests that tailoring CAR T-cell dosing based on pre-lymphodepletion tumor burden can optimize the risk-benefit profile. ()
Phase 2
Checkpoint inhibitors, obinutuzumab plus PET-adapted ultra-low dose nodal radiotherapy yield high efficacy in treatment-naïve follicular lymphoma: Results from the phase II 'FLUORO' study. The Phase II 'FLUORO' study presents a novel chemo-free regimen for treatment-naïve follicular lymphoma, combining obinutuzumab, atezolizumab, and PET-adapted ultra-low dose radiotherapy. This multimodality approach achieved a 93% complete response rate and an 80% 3-year progression-free survival, offering a promising and safe alternative to traditional chemoimmunotherapy. ()
Phase 2
Polatuzumab Vedotin Combined With R-ICE (PolaR-ICE) as Second-Line Therapy in Diffuse Large B-Cell Lymphoma. The PolaR-ICE regimen (polatuzumab vedotin plus R-ICE) proved to be a safe and effective second-line salvage therapy for R/R DLBCL, achieving an 88% overall response rate and a 56% complete response rate. This combination represents a viable option for patients with late relapse or in regions with limited access to CAR T-cell therapy. ()
Phase 3
Psychometric analysis of new lymphoma-specific patient-reported symptom measures derived from the EORTC item library. This study validated three new patient-reported outcome (PRO) measures for lymphoma symptoms (CLL/SLL, MCL, and Expanded Fatigue) using data from two Phase 3 trials. The measures demonstrated strong psychometric properties, confirming their appropriateness for use in clinical trials to assess meaningful changes in patient symptoms. ()
Phase 2
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. A Phase 2 trial showed that a conditioning regimen of total marrow and lymphoid irradiation (2000 cGy) with high-dose cyclophosphamide and etoposide before allogeneic HCT is safe and effective for patients with relapsed or refractory acute leukaemia. The regimen resulted in an encouraging 2-year progression-free survival of 34% with minimal organ toxicity. ()
Phase 2
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 multitargeted first-line outpatient regimen for mantle cell lymphoma, achieving a 90% complete metabolic response rate and undetectable MRD in 79% of patients. This efficient, six-cycle combination of VR-CAP, R-cytarabine, and continuous acalabrutinib presents a highly effective strategy that allows for flexible, MRD-guided consolidation decisions. ()
Phase 2
A lipid-immune network signature defines susceptibility to asparaginase-associated pancreatitis. This study identified a reproducible lipid-immune network signature that predicts susceptibility to asparaginase-associated pancreatitis (AAP) in pediatric ALL. These findings suggest that a failure of coordinated lipid-immune responses under therapeutic stress confers vulnerability to AAP, providing a framework for future mitigation strategies. ()
PHASE1, PHASE2
Final phase 2 study results of acalabrutinib in treatment-naive and relapsed/refractory chronic lymphocytic leukemia. Final long-term results from a Phase 1/2 study confirm the durable benefit and safety of acalabrutinib monotherapy in both treatment-naïve (TN) and relapsed/refractory (R/R) CLL/SLL. With a median follow-up of over 73 months for TN patients, the 72-month PFS rate was 86.7%, and no new safety signals emerged over time. ()
Phase 3
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 Phase 3 frontMIND trial showed that adding tafasitamab and lenalidomide to R-CHOP significantly improved progression-free survival compared to R-CHOP alone in first-line high-risk DLBCL (HR 0.75). Despite a higher rate of grade ≥3 adverse events, this regimen may represent a new first-line treatment option, with overall survival follow-up ongoing. ()
Phase 2
Zanubrutinib, Obinutuzumab, and Venetoclax in CLL: Long-Term Follow Up, MRD Kinetics, Retreatment, T-Cell Profiling, PKs. The BOVen triplet regimen (zanubrutinib, obinutuzumab, venetoclax) induced high rates of undetectable MRD (92% in blood and bone marrow) with a short median treatment duration of 10 months in treatment-naïve CLL. A novel biomarker, ΔMRD400, identified patients with faster and more durable responses, suggesting its potential to guide treatment duration in future trials. ()
PHASE1, PHASE2
A phase 1/2 study of duvelisib plus venetoclax in patients with relapsed/refractory CLL/SLL or Richter transformation. The combination of duvelisib and venetoclax was highly active in heavily pre-treated R/R CLL/SLL, achieving a 60% complete response rate and a median PFS of 46 months. Despite notable toxicities, the regimen also showed activity in Richter transformation, offering a potential option for this high-risk population. ()
Phase 3
Disease characteristics and treatment outcomes in patients with resected early-stage ALK-positive non-small cell lung cancer from the randomized ALINA trial. An exploratory analysis of the ALINA trial confirmed that adjuvant alectinib provides a consistent and significant disease-free survival benefit over platinum-based chemotherapy in resected early-stage ALK-positive NSCLC. This benefit was maintained across all subgroups, regardless of disease stage, nodal status, or tumor size. ()
PHASE1, PHASE2
Anbalcabtagene autoleucel (PD-1 and TIGIT knockdown CD19 CAR-T) for relapsed/refractory large B-cell lymphoma (CRC01-01). Anbalcabtagene autoleucel (Anbal-cel), a CD19 CAR T-cell therapy with dual PD-1 and TIGIT knockdown, demonstrated a 67.1% complete response rate in patients with R/R LBCL. Enhanced CAR T-cell expansion and reduced PD-1/TIGIT expression were associated with long-term responses, highlighting the potential of this next-generation CAR-T to improve durability. ()
PHASE1, PHASE2
A Phase 1 dose-escalation study to evaluate safety, pharmacokinetics, and pharmacodynamics of OSE-279, an anti-PD-1 monoclonal antibody in patients with advanced solid tumours. The anti-PD-1 antibody OSE-279 was well-tolerated and showed durable responses in a Phase 1 study of patients with advanced solid tumors, establishing recommended Phase 2 doses of 300 mg q3w and 600 mg q6w. The trial is now advancing to evaluate OSE-279 in combination with a cancer vaccine for first-line PD-L1≥50% NSCLC. ()
PHASE1, PHASE2
Cognitive Functioning in Vorinostat-Treated Pediatric and Young Adult Patients Over the First 180 Days After Hematopoietic Stem Cell Transplant. A secondary analysis of a Phase I/II trial found that the HDAC inhibitor vorinostat, used for GVHD prophylaxis, did not cause additional cognitive or psychological deficits in pediatric and young adult patients during the first 180 days post-HSCT. This establishes a favorable cognitive safety profile for vorinostat in this vulnerable population. ()
Phase 3
IGNITE: a phase III study of tirabrutinib versus rituximab and temozolomide combination therapy in relapsed/refractory primary central nervous system lymphoma. The ongoing Phase III IGNITE trial is evaluating the efficacy and safety of the BTK inhibitor tirabrutinib against rituximab and temozolomide in patients with relapsed/refractory primary central nervous system lymphoma (R/R PCNSL). This study aims to address a significant unmet need for approved therapies in this aggressive disease, with progression-free survival as the primary endpoint. ()
Phase 3
Renoir phase III Rituximab-Lenalidomide vs Rituximab as Maintenance Treatment in Relapsed/Refractory Follicular Lymphoma. The Phase III RENOIR trial found that adding lenalidomide to rituximab (R2) for maintenance did not significantly improve 2-year PFS compared to rituximab alone in elderly patients with R/R follicular lymphoma. However, a subgroup analysis suggested a potential benefit for patients younger than 70, indicating a need for careful patient selection. ()
PHASE1, PHASE2
Liposomal mitoxantrone plus tislelizumab in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma: a phase 1b/2 trial. The combination of liposomal mitoxantrone and the anti-PD-1 antibody tislelizumab demonstrated promising efficacy and an acceptable safety profile in patients with R/R ENKTL. The regimen achieved a 53% complete response rate, meeting its primary endpoint and offering a new potential treatment for this difficult-to-treat lymphoma subtype. ()
Phase 2
Homeodomain-driven oncogenic diversion to a γδTCR phenotype in T-cell acute lymphoblastic leukemia. This study delineates two distinct subtypes of γδTCR+ T-ALL, revealing that the majority are "cortical-like" T-ALLs where homeodomain oncogenes repress αβ-lineage commitment. The less common "bona fide" γδ T-ALL subtype was associated with a poor initial response but showed sensitivity to venetoclax, highlighting new therapeutic avenues. ()
Phase 1
Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer. This integrative analysis justifies the lower 400 mg starting dose of ribociclib in early breast cancer (EBC), revealing population-specific differences in pharmacokinetics and QTcF response compared to advanced breast cancer. The 400 mg dose in EBC provides a more favorable safety profile regarding neutropenia and QTcF prolongation while maintaining efficacy. ()
Phase 2
Results from a Pilot Study of HyBryte™ (Topical Synthetic Hypericin) Versus Valchlor® (Mechlorethamine) in the Treatment of CTCL. In a pilot study for early-stage cutaneous T-cell lymphoma (CTCL), HyBryte™ (topical hypericin photodynamic therapy) demonstrated a higher overall response rate (60% vs. 20%) and a superior safety profile compared to Valchlor® (mechlorethamine). HyBryte™ was well-tolerated with no local adverse events, suggesting it could be a favorable skin-directed therapy. ()
Phase 3
Phase 3 PERSPECTIVE study: Ibrutinib with rituximab for initial treatment of patients with follicular lymphoma. In the Phase 3 PERSPECTIVE study for previously untreated follicular lymphoma, adding ibrutinib to rituximab significantly improved progression-free survival (42.0 vs. 32.8 months) and response rates compared to rituximab alone. However, this benefit came with increased grade ≥3 adverse events and did not translate to an overall survival advantage. ()
Phase 1
Feasibility and Safety of a Novel CD19-Directed CAR T-Cell Therapy in Patients with R/R B-Cell Non-Hodgkin Lymphoma. A novel CD19-directed CAR T-cell therapy (UCD19), featuring a TNFRSF19 transmembrane domain, demonstrated a favorable safety profile with no grade ≥3 CRS or ICANS in a Phase 1 trial for R/R B-cell NHL. The therapy achieved a 90% overall response rate and a 70% complete response rate at 90 days, supporting further investigation. ()
Phase 1
Distinct in vivo dynamics of donor-derived stem cell memory CAR T cells post-allogeneic HSCT relapse. This first-in-human study shows that donor-derived CAR T cells engineered from a stem-cell memory T (TSCM) cell population exhibit superior expansion and persistence compared to standard CAR T cells for B-cell malignancies relapsing after allo-HSCT. CAR TSCM cells enabled complete responses at low doses without lymphodepletion, establishing them as a promising next-generation platform. ()
Phase 1
Phase 1 study of zanubrutinib plus lenalidomide for patients with relapsed/refractory diffuse large B-cell lymphoma. The combination of zanubrutinib and lenalidomide demonstrated acceptable tolerability and promising antitumor activity in patients with R/R DLBCL, with an overall response rate of 58% at the recommended Phase 2 dose. The median duration of response was 14.9 months, supporting this combination as a potential new therapeutic option. ()
Phase 2
Gonadal function and fertility after Hodgkin lymphoma treatment with nivolumab-AVD in the phase 2 GHSG NIVAHL trial. The Phase 2 GHSG NIVAHL trial reports that first-line treatment with nivolumab plus AVD (N-AVD) for classic Hodgkin lymphoma appears to preserve gonadal function and fertility. Hormone levels remained stable for up to 24 months post-treatment, suggesting a favorable long-term safety profile for this regimen. ()
Phase 3
Cost-Effectiveness Analysis of Second-Line Lisocabtagene Maraleucel in the Treatment of Refractory or Relapsed Large B-Cell Lymphoma. Based on data from the TRANSFORM trial, this analysis concludes that lisocabtagene maraleucel (liso-cel) is a cost-effective second-line treatment for R/R large B-cell lymphoma in France compared to the standard of care. Liso-cel generated more quality-adjusted life years (QALYs) with an incremental cost-utility ratio of €24,580 per QALY gained. ()
Phase 3
Lenalidomide plus rituximab for previously untreated advanced follicular lymphoma: the 10-year RELEVANCE trial analysis. The final 10-year analysis of the RELEVANCE trial confirms that the chemotherapy-free R2 regimen (rituximab + lenalidomide) provides comparable long-term efficacy to rituximab-based immunochemotherapy for previously untreated follicular lymphoma. With a 10-year overall survival rate of over 81% in both arms, R2 remains a viable alternative to chemoimmunotherapy. ()
PHASE1, PHASE2
Five-Year Follow-Up: Tandem CD19/CD20 CAR T Therapy Enduring Impact on Refractory/Relapsed Non-Hodgkin Lymphoma. The 5-year follow-up of tandem CD19/CD20 CAR T-cell therapy (TanCAR7) demonstrates durable remissions in patients with r/r NHL, with 40% of patients remaining in remission and an estimated 5-year overall survival rate of 60.1%. High tumor burden and inflammation were identified as risk factors for relapse, while high levels of endogenous T-cells post-infusion correlated with benefit. ()
Phase 1
CPX-351 in High-Risk Relapsed Pediatric Acute Leukemia: Real-World Phase 1 Data Establishing the FDA-Approved Dose. This Phase 1 study established the FDA-approved pediatric dose of CPX-351 for R/R acute leukemia, demonstrating its safety and tolerability. The therapy showed promising activity in heavily pretreated, high-risk pediatric AML, with a 48% overall response rate, supporting its use in this challenging patient population. ()
Phase 2
Ten-Year Outcomes after CAR T-Cell Therapy for B-Cell Lymphomas. A 10-year follow-up of patients treated with tisagenlecleucel (CTL019) for R/R B-cell lymphomas shows the potential for cure, with no relapses occurring beyond 5.4 years. Decade-long lymphoma-free survival was achieved in 32% of patients with large B-cell lymphoma and 47% with follicular lymphoma, establishing the long-term durability of this single-infusion therapy. ()
Phase 1
Carfilzomib plus induction chemotherapy in children with relapsed or refractory acute lymphoblastic leukemia. A Phase 2 study of carfilzomib combined with induction chemotherapy (CFZ-VXLD) in pediatric R/R ALL did not meet its primary endpoint of superior complete remission rates compared to an external control. However, the regimen showed a higher overall response rate in B-ALL, suggesting it may be an option for select patients in this high-unmet-need population. ()
Phase 1
Five-year survival outcomes from TRANSCEND NHL 001 of lisocabtagene maraleucel in R/R LBCL. The 5-year follow-up from the TRANSCEND NHL 001 study confirms the long-term survival benefit and curative potential of lisocabtagene maraleucel (liso-cel) in R/R LBCL. The estimated 5-year overall survival rate was 38%, and the disease-specific survival rate was 52%, with no new safety signals emerging over the long-term follow-up period. ()
Phase 1
CD19/CD22 bivalent CAR T cells in children, adolescents and young adults with B-ALL: final phase 1 trial results. Final Phase 1 results show that a bivalent CD19/CD22 CAR T-cell therapy is safe and effective as a bridge to HSCT for children and young adults with B-ALL, achieving an 89.3% MRD-negative complete remission rate. Non-response was primarily seen in patients with non-CNS extramedullary disease, highlighting a key challenge for future CAR T-cell designs. ()
Phase 3
Efficacy of alectinib for ALK-positive NSCLC according to tumor burden and body mass index: A pooled analysis of the randomized phase III trials ALEX and J-ALEX. A pooled analysis of the ALEX and J-ALEX trials identified high tumor burden as a negative prognostic factor for both PFS and OS in first-line ALK-positive NSCLC. The PFS benefit of alectinib over crizotinib was greater in patients with low tumor burden, suggesting that treatment intensification may be needed for high-burden patients. ()
Phase 3
Validation of the newly introduced Deauville Score 5a in patients treated for advanced-stage classic Hodgkin Lymphoma. This study validates the prognostic value of the refined Deauville Score (DS) in advanced-stage classic Hodgkin lymphoma, showing that the new DS5a sub-category effectively identifies a small, high-risk patient group. This refinement supports improved risk assessment and treatment adaptation based on interim PET scans. ()
Phase 1
Long-Term Outcomes of Second Allogeneic Transplantation Following CD7 CAR-T in Remission for T-Cell Acute Lymphoblastic Leukemia or Lymphoma. CD7 CAR-T therapy demonstrated a high remission rate (91.3%) in T-ALL/LBL patients who relapsed after a first allo-HSCT. Consolidating this remission with a second allo-HSCT appears to be a feasible and promising strategy for long-term survival in this heavily pretreated population, although non-relapse mortality remains a challenge. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in lymphoma updated from 2026-06-01 to 2026-06-30:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation-------
Not Yet Recruiting54722-20
Recruiting24183119-83
Available-------
Approved for Marketing-------
Active, Not Recruiting21143124-72
Completed3-1-1-5
Total533670516-180
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Tirabrutinib NCT07198087 COMPLETED A Phase 1, Open-Label, Parallel-Group Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants 2026-04-20
odronextamab, cemiplimab NCT02651662 COMPLETED A Phase 1 Study to Assess Safety and Tolerability of Odronextamab (REGN1979) an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, and Cemiplimab (REGN2810), an Anti-Programmed Death-1 Monoclonal Antibody in Patients With B-Cell Malignancies (CLIO-1) 2026-04-29
Opemalirsen (AZD2373) NCT07154901 COMPLETED 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
: Biological/Genetically Modified T cells, Cyclophosphamide-based chemotherapy NCT01430390 ACTIVE_NOT_RECRUITING A Phase I Trial Using In Vitro Expanded Allogeneic Epstein-Barr Virus Specific Cytotoxic T-Lymphocytes (EBV-CTLs) Genetically Targeted to the CD19 Antigen in B-cell Malignancies 2026-09
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Tyrosine kinase inhibitor, Brigatinib NCT04318938 COMPLETED Advancing Brigatinib Properties in Anaplastic Lymphoma Kinase Positive Non-small Cell Lung Cancer (ALK+ NSCLC) Patients 2026-05-30
: Obinutuzumab, Bendamustine, Venetoclax NCT03872180 ACTIVE_NOT_RECRUITING A Phase II Evaluation of Bendamustine, Obinutuzumab and Venetoclax in Patients With Untreated Mantle Cell Lymphoma 2026-07-15
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Crizotinib, Alectinib NCT02838420 COMPLETED Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Asian Patients With Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer 2026-05-11
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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