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LymphomaJanuary 2026
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Lymphoma — Monthly Compass
Jan 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
    • Subcutaneous epcoritamab monotherapy demonstrated a Phase 3 PFS benefit versus investigator’s choice in transplant‑ineligible relapsed/refractory DLBCL (HR 0.74 with higher CRR and DoR, OS not statistically significant) and positioned CD3xCD20 engagers as a non‑cell therapy core option.
  • Important Drug Publication Updates
    • The Phase 3 EPCORE FL‑1 trial showed epcoritamab added to lenalidomide‑rituximab achieved 95% ORR versus 79% with R2 and reduced risk of progression or death by 79% (HR 0.21) in relapsed/refractory follicular lymphoma, supporting the combination as a potential new standard of care.
    • The Phase 3 inMIND study demonstrated that adding tafasitamab to lenalidomide‑rituximab improved PFS (median 22.4 vs 13.9 months; HR 0.43) with acceptable safety in relapsed/refractory follicular lymphoma.
  • Key Clinical Development Updates
    • Incyte announced positive Phase 3 frontMIND topline for tafasitamab plus lenalidomide added to R‑CHOP in newly diagnosed DLBCL with a planned U.S. sBLA in 1H26 and global regulatory engagement, while ADC Therapeutics guided to LOTIS‑5 topline in 2Q26 for loncastuximab tesirine plus rituximab in 2L+ DLBCL with a contingent sBLA to convert accelerated approval and expand the label.
    • Cellectar reported FDA feedback confirming a traditional accelerated approval pathway and highlighted Breakthrough Therapy Designation for iopofosine I‑131 in Waldenström macroglobulinemia, whereas Atara received an FDA Complete Response Letter for tabelecleucel in EBV+ PTLD—citing inadequacy of the single‑arm ALLELE trial for accelerated approval, unrelated to safety or manufacturing—with a Type A meeting to be requested within 45 days.
  • Important Clinical Trial Publications
    • Five‑year follow‑up of JULIET confirmed durable benefit of tisagenlecleucel in relapsed/refractory large B‑cell lymphoma, with a 60‑month relapse‑free probability of 61% among responders and no new safety signals or secondary T‑cell malignancies.
    • First‑MIND showed that rapid ctDNA clearance during tafasitamab‑based therapy correlated strongly with superior progression‑free survival in DLBCL, with early and end‑of‑treatment ctDNA potentially offering higher specificity than PET/CT in some contexts.
  • Key Conference Updates
    • LOTIS‑7 reported ZYNLONTA (loncastuximab tesirine) plus glofitamab produced 89.8% ORR and 77.6% CR in efficacy‑evaluable relapsed/refractory DLBCL, highlighting complementary targeting and immune activation with ADC–bispecific pairing.
    • The 17th Annual T‑Cell Lymphoma Forum emphasized adoptive cellular therapies, therapeutic innovations, and CTCL management to catalyze disease‑specific trials across PTCL subtypes with significant unmet need.
  • Emerging Themes & Macro-Trends
    • Outpatient‑amenable subcutaneous bispecifics and fixed‑duration, chemo‑sparing regimens are moving toward earlier lines, with ADC–bispecific combinations prioritized to deepen responses in chemo‑refractory LBCL.
    • Stakeholders are prioritizing SC, community‑deployable assets and investment in ADC–bispecific platforms while preparing for label and compendia expansions that broaden community‑oncology access.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • On January 27, 2026, the FDA approved Janssen Biotech, Inc.'s Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. This approval is based on efficacy data from the CEPHEUS trial, demonstrating improved minimal residual disease negativity rate and progression-free survival in patients with hematological malignancies.¹ (read more)
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Incyte reported positive phase 3 frontMIND results for tafasitamab (Monjuvi/Minjuvi) plus lenalidomide added to R-CHOP in newly diagnosed DLBCL and said it plans to submit a U.S. supplemental BLA in the first half of 2026. The company also noted it will engage with regulators globally based on these data.¹ (read more)
  • ADC Therapeutics issued a January corporate update guiding to LOTIS-5 phase 3 topline data for ZYNLONTA (loncastuximab tesirine) + rituximab in 2L+ DLBCL in 2Q26, stating that, if positive, a U.S. supplemental BLA submission will follow. The company linked the filing to converting its existing accelerated approval and a potential label expansion.² (read more)
  • Cellectar Biosciences’ JPM-week update reiterated FDA feedback “confirming [a] traditional accelerated approval pathway” for iopofosine I-131 in Waldenström macroglobulinemia (a lymphoplasmacytic lymphoma) and highlighted prior Breakthrough Therapy Designation. The company also outlined European plans while emphasizing the U.S. accelerated approval strategy.³ (read more)
  • Atara Biotherapeutics announced the FDA issued a Complete Response Letter for the tabelecleucel (EBVALLO/tab-cel) BLA for EBV+ post-transplant lymphoproliferative disease and said Pierre Fabre (BLA sponsor) will request a Type A meeting within 45 days. The company stated the CRL was not related to safety or manufacturing and that FDA now deems the single‑arm ALLELE trial inadequate to support accelerated approval.⁴ (read more)
Publications Related to Approved Drugs
Phase 2
tisagenlecleucel
Five-Year Analysis of the JULIET Trial of Tisagenlecleucel in Patients With Relapsed/Refractory Large B-Cell Lymphoma The five-year follow-up of the pivotal JULIET trial confirms the curative potential of tisagenlecleucel in relapsed/refractory large B-cell lymphoma, reporting a 60-month relapse-free probability of 61% among responders. Durable clinical benefit was associated with lower baseline inflammatory markers (LDH and CRP), and no new safety signals or secondary T-cell malignancies were observed over the extended monitoring period.
Phase 3
polatuzumab vedotin
PROs vs clinician-reported adverse events in a large clinical trial: findings from the phase 3 POLARIX study In this analysis of the phase 3 POLARIX trial for diffuse large B-cell lymphoma, patient-reported outcomes (PROs) identified a higher incidence of symptoms than clinician-reported adverse events, underscoring the value of PROs in accurately capturing treatment tolerability. Despite this discordance, patients treated with polatuzumab vedotin plus R-CHP experienced rapid and sustained improvements in quality of life and lymphoma symptoms comparable to standard R-CHOP.
Phase 3
zanubrutinib
An Indirect Comparison of Zanubrutinib vs Acalabrutinib Plus Venetoclax in Patients With Treatment-Naive CLL A matching-adjusted indirect comparison demonstrates that zanubrutinib monotherapy yields superior investigator-assessed progression-free survival compared to the combination of acalabrutinib and venetoclax in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma. These findings support zanubrutinib as a highly effective fixed-duration alternative that may obviate the need for more intensive combination regimens in this setting.
PHASE1, PHASE2
mosunetuzumab
Mosunetuzumab is effective and well tolerated in older patients with relapsed/refractory follicular lymphoma: Subgroup analysis of a phase I/II study Subgroup analysis reveals that mosunetuzumab achieves numerically higher overall and complete response rates in patients aged ≥65 years with relapsed/refractory follicular lymphoma compared to younger patients. The bispecific antibody demonstrated a manageable safety profile with no increase in serious adverse events in the elderly population, highlighting its viability for older patients with limited treatment options.
Phase 3
brentuximab vedotin
Tumor-specific immune responses and biomarkers in pediatric patients with high-risk Hodgkin lymphoma Research from the phase 3 AHOD1331 trial indicates that brentuximab vedotin combined with chemotherapy fosters a favorable immune microenvironment in pediatric high-risk Hodgkin lymphoma by enhancing tumor-specific T-cell responses and reducing soluble CD30 and TARC levels. This immunomodulation suggests that the regimen may effectively prime the tumor environment for subsequent cellular or immune-based therapies.
New Publications Related to Drugs in Clinical Trial Development
Phase 3
Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial. The Phase 3 EPCORE FL-1 trial demonstrated that adding epcoritamab to lenalidomide and rituximab (R2) significantly improved outcomes in patients with relapsed or refractory follicular lymphoma compared to R2 alone. The combination achieved a 95% overall response rate versus 79% for R2, and reduced the risk of progression or death by 79% (HR 0.21), positioning it as a potential new standard of care.
Phase 3
Tafasitamab, lenalidomide, and rituximab in relapsed or refractory follicular lymphoma (inMIND): a global, phase 3, randomised controlled trial. In the Phase 3 inMIND study, the addition of tafasitamab to the standard lenalidomide and rituximab regimen resulted in a statistically significant improvement in progression-free survival (median 22.4 vs 13.9 months; HR 0.43) for patients with relapsed or refractory follicular lymphoma. The safety profile was acceptable, suggesting this triplet therapy could serve as an effective new treatment option in this setting.
Phase 3
Noninvasive genotyping and early disease dynamics demonstrate the efficacy of ibrutinib in combination with immunochemotherapy in patients with mantle cell lymphoma treated in the TRIANGLE trial. Molecular analysis from the TRIANGLE trial showed that adding ibrutinib to first-line immunochemotherapy in mantle cell lymphoma improved outcomes by inducing deeper responses, including higher rates of ctDNA clearance. The study highlighted that measurable residual disease (MRD) assessment by qPCR was highly predictive of outcomes and that ibrutinib may help overcome high-risk features like TP53 mutations.
Phase 1/2
Epcoritamab monotherapy for Richter transformation (EPCORE CLL-1): findings from a single-arm, multicentre, open-label, phase 1b/2 trial. Epcoritamab monotherapy showed clinically meaningful activity in patients with Richter transformation, a high-risk condition with limited options, achieving an overall response rate of 47.6%. The safety profile was consistent with previous reports, supporting further investigation of this bispecific antibody for this difficult-to-treat population.
Phase 2
Axicabtagene ciloleucel in combination with rituximab for refractory large B cell lymphoma: the phase 2, single-arm ZUMA-14 trial. The ZUMA-14 trial demonstrated that combining axicabtagene ciloleucel with rituximab in refractory large B-cell lymphoma yielded a high complete response rate of 73% and durable responses. The strategy was feasible and safe, with no new toxicity signals, and aims to potentially limit antigen escape through dual targeting of CD19 and CD20.
Phase 1/2
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. Data from the FELIX trial suggests that a tumor burden-guided split-dosing strategy for obecabtagene autoleucel effectively mitigates severe cytokine release syndrome and neurotoxicity in adult B-ALL patients. High remission rates were maintained across both low and high tumor burden groups, supporting this dosing approach to optimize the therapeutic index.
Phase 1/2
Three-year follow-up of epcoritamab therapy in Japanese patients with relapsed/refractory follicular lymphoma in EPCORE NHL-3. Long-term follow-up of Japanese patients with relapsed/refractory follicular lymphoma treated with epcoritamab monotherapy confirmed deep and durable responses, with a 95.2% overall response rate. At three years, nearly 93% of complete responders remained alive, reinforcing the favorable long-term efficacy and safety of this regimen.
Phase 1/2
Pirtobrutinib, a Highly Selective, Non-covalent (Reversible) BTKi in R/R Marginal Zone Lymphoma: Phase 1/2 BRUIN Study. Pirtobrutinib demonstrated promising efficacy in heavily pre-treated patients with relapsed/refractory marginal zone lymphoma, achieving an overall response rate of 55.6%. The drug was effective even in patients who had previously received covalent BTK inhibitors, addressing a significant unmet need in this population.
Phase 1/2
Patient-reported outcomes among patients with mantle cell lymphoma or chronic lymphocytic leukemia receiving pirtobrutinib in the BRUIN phase 1/2 study: final analysis. In the BRUIN trial, patients with CLL/SLL and mantle cell lymphoma treated with pirtobrutinib reported stable or improved health-related quality of life and physical function. These patient-reported outcomes were sustained throughout treatment, complementing the clinical efficacy data.
Phase 1/2
Genomic determinants of response and resistance to pirtobrutinib in relapsed/refractory chronic lymphocytic leukemia. Genomic analysis of patients in the BRUIN trial revealed complex clonal dynamics, with resistance to pirtobrutinib often involving acquired BTK mutations, including gatekeeper and kinase-impaired mutations. However, a significant proportion of progressions occurred without obvious genomic drivers, highlighting the need to further understand resistance mechanisms.
Phase 2/3
Efficacy of Brentuximab-Vedotin Combined with PD-1 Inhibitors in Relapsed/Refractory Hodgkin Lymphoma with ASCT Consolidation and Maintenance Therapy: A Phase 2 Clinical Trial. A Phase 2 trial evaluating brentuximab-vedotin combined with a PD-1 inhibitor followed by autologous stem cell transplant and maintenance showed excellent outcomes, with 100% overall survival and 80% progression-free survival. This strategy appears highly effective and safe for patients with relapsed/refractory Hodgkin lymphoma.
Phase 2
Health-related quality of life after second-line Axi-cel in transplant-ineligible patients with large B-cell lymphoma. In the ALYCANTE trial, second-line treatment with axi-cel for transplant-ineligible large B-cell lymphoma patients caused a transient decline in quality of life at one month, which recovered by three months. These findings support the use of axi-cel in this population, showing that quality of life outcomes are comparable to those seen in transplant-eligible patients.
Phase 1
Zamtocabtagene Autoleucel in Relapsed/refractory B-NHL: 5-year Follow Up of a CD20/19 tandem CAR T Cell Phase 1 Trial. Five-year follow-up of a tandem CD20-CD19 CAR-T therapy (zamtocabtagene autoleucel) in relapsed/refractory B-NHL demonstrated a 75% best overall response rate with durable complete remissions. The dual-targeting approach appeared to prevent antigen escape-mediated relapses, with no late relapses observed in complete responders.
Phase 1
ctDNA dynamics demonstrates rapid treatment response to tafasitamab + R-CHOP +/- lenalidomide and predicts outcome in diffuse large B-cell lymphoma: results from the phase 1b First-MIND study. Analysis of the First-MIND trial showed that rapid clearance of circulating tumor DNA (ctDNA) was strongly associated with superior progression-free survival in DLBCL patients treated with tafasitamab-based regimens. ctDNA detection at early timepoints and end of treatment was a significant predictor of outcome, potentially offering higher specificity than PET/CT in some contexts.
Phase 2
Pharmacokinetics of Odronextamab, A Bispecific T-Cell-Engaging Antibody, in Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma. Pharmacokinetic modeling of odronextamab in B-NHL patients identified target-mediated clearance that decreases over time, consistent with B-cell depletion. Baseline body weight and albumin levels were identified as significant covariates affecting drug exposure, informing dosing considerations.
Phase 1
CAR HEMATOTOX independently predicts outcomes after CD19 CAR-T therapy for acute lymphoblastic leukemia. The CAR HEMATOTOX score was validated as an independent prognostic factor for adult B-cell ALL patients receiving CD19 CAR-T therapy. A low score was associated with significantly better overall and event-free survival, as well as lower rates of severe infections and delayed neutrophil recovery.
Phase 2
Dose-dense chemotherapy enables elimination of RT for majority of low-risk pediatric Hodgkin lymphoma: PHC study HOD08. A study of a dose-dense modified Stanford V regimen in low-risk pediatric Hodgkin lymphoma allowed over 76% of patients to achieve complete remission without radiation therapy. The approach maintained excellent 5-year event-free survival (87.4%) while sparing a majority of young patients from the long-term risks of radiation.
Phase 1/2
Tafasitamab as Monotherapy or in Combination in Japanese Patients With B-Cell Non-Hodgkin Lymphoma: Results From the Phase 1b J-MIND Study. A Phase 1b study confirmed that tafasitamab, administered alone or in combination with lenalidomide or other agents, has a manageable safety profile in Japanese patients with B-cell NHL. No new safety signals were identified, supporting the feasibility of these regimens in this population.
Phase 3
Risk stratification of patients with diffuse large B-cell lymphoma using plasma NMR-based metabolomics at diagnosis. A retrospective study identified a three-metabolite plasma signature linked to lipid metabolism that successfully stratified DLBCL patients into distinct risk groups. This NMR-based score significantly correlated with overall and progression-free survival, offering a potential new tool for refining patient prognosis beyond standard clinical factors.
Phase 1/2
Targeting Aurora Kinase A to Prevent GVHD and Relapse after Myeloablative Allogeneic Hematopoietic Cell Transplantation. A Phase 1 trial demonstrated that adding the Aurora kinase A inhibitor VIC-1911 to post-transplant cyclophosphamide and sirolimus is safe and effective for GVHD prevention in myeloablative alloHCT. The combination resulted in no grade III-IV acute GVHD and no relapses at one year, suggesting a potent dual benefit.
Phase 1/2
Phase I Study of Mogamulizumab in Combination with Pembrolizumab in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma-A National Cancer Institute Experimental Therapeutics Clinical Trials Network (NCI-ETCTN) Trial. A Phase 1 trial evaluating the combination of mogamulizumab and pembrolizumab in relapsed/refractory NHL was terminated early due to severe toxicity and suspected hyper-progression. The study concluded that this specific immunotherapy combination is poorly tolerated and potentially detrimental in lymphoma patients.
Phase 1/2
Nivolumab plus brentuximab vedotin for relapsed/refractory diffuse large B-cell lymphoma. The CheckMate 436 study found that the combination of nivolumab and brentuximab vedotin had limited efficacy in relapsed/refractory DLBCL, with an overall response rate of only 28.6%. High rates of adverse events were observed, leading the authors to conclude that this regimen is not supported for use in this setting.
Phase 3
International Prognostic Models as Tools for Selection of Higher-risk Trial-eligible Patients With Diffuse Large B-Cell lymphoma. An analysis of the frontMIND trial criteria suggests that standard prognostic models like IPI and aaIPI may fail to identify a subset of high-risk DLBCL patients, particularly those who are younger. The findings emphasize the need for improved risk stratification tools to better select patients for clinical trials of novel therapies.
Phase 1/2
High-throughput proteomic profiling to evaluate differentiation syndrome with menin inhibition. Researchers utilized a novel high-throughput proteomic technology (NULISA) to characterize soluble protein changes in pediatric AML patients treated with the menin inhibitor revumenib. This approach successfully identified dynamic inflammatory markers associated with differentiation syndrome, potentially aiding in the management of this specific therapy-related complication.
Phase 2/3
Optimizing Asparaginase Treatment for Adolescent and Young Adult (AYA) Patients With Acute Lymphoblastic Leukemia: US Consensus Panel Recommendations. A consensus panel developed recommendations to address the unique challenges of administering pediatric-inspired asparaginase regimens to adolescent and young adult (AYA) patients. The guidelines focus on managing toxicities and logistical barriers to improve treatment adherence and outcomes in this specific age group.
Early Phase 1
Exercise-Mobilized Lymphocytes Enhance the Function of Cytokine-Induced Memory-like NK-cells Against Myeloid Leukemia. Preclinical and early clinical data indicate that NK cells mobilized by acute exercise and pre-activated with cytokines exhibit superior anti-leukemic activity compared to standard NK cells. These "exercise-mobilized" cells demonstrated enhanced cytotoxicity and prolonged survival in animal models, suggesting a novel method to improve adoptive cell therapy.
Phase 1/2
Safety and immunogenicity of BNT162b2 vaccine in children with acute leukaemia: results and perspectives of an open-label, two-centre, phase 1/2 trial with dose finding study. The PACIFIC trial showed that administering adult doses (30 μg) of the BNT162b2 COVID-19 vaccine to children with acute leukemia was safe and elicited robust T-cell responses. The findings support using higher vaccine doses to ensure adequate immunogenicity in immunocompromised pediatric patients undergoing chemotherapy.
Phase 3
Trajectory of Neurocognitive Functioning in Children Treated for Acute Lymphoblastic Leukemia (ALL): Dana-Farber Cancer Institute ALL Consortium Study 16-001. A longitudinal study of children treated for ALL found that while many maintain normal neurocognitive function, a specific subgroup—particularly older children and females—is at higher risk for deficits in attention and executive function. These findings highlight the importance of early monitoring and potential intervention for at-risk patients during therapy.
Phase 1/2
Phase I Studies of HLX26, A Novel Anti-LAG-3 Antibody, Monotherapy or Combination Therapy in Patients with Advanced Solid Tumors. Phase 1 studies of HLX26, a novel anti-LAG-3 antibody, demonstrated that it was well-tolerated as a monotherapy and in combination with a PD-1 inhibitor in patients with advanced tumors, including lymphomas. No dose-limiting toxicities were observed, supporting continued clinical development of this checkpoint inhibitor.
N/A
Peaceful Acceptance of Illness Among Older Adults With Advanced Cancer: A Randomized Clinical Trial. A secondary analysis of a cluster-randomized trial in older adults with advanced cancer, including lymphoma, found that peaceful acceptance of illness was strongly linked to better psychological health. The study suggests that interventions targeting illness acceptance could improve end-of-life care and quality of life for geriatric oncology patients.
Conference
Major Conference Updates
Conference Information
  • 17th Annual T-Cell Lymphoma Forum, Hyatt Regency La Jolla at Aventine, January 29–31, 2026. (read more)
  • Overall sentiment: January 2026 signals consolidation of off‑the‑shelf biologics in lymphoma—first Phase 3 PFS win for a bispecific monotherapy and striking ADC+bispecific activity—while TCLF highlights accelerating innovation in T‑cell entities. (read more)
  • Theme 1: Bispecific Monotherapy Validated in R/R DLBCL
    • Significance: Establishes CD3xCD20 T‑cell engagers as a potential core option in transplant‑ineligible R/R DLBCL, creating a non‑cell therapy alternative with registrational momentum. (read more)
    • Mechanism insights / clinical impact: Subcutaneous epcoritamab (DuoBody CD3xCD20) improved PFS vs investigator’s choice (HR 0.74; CRR and DoR favored epcoritamab) with OS not statistically significant; safety consistent with known profile—supporting real‑world practicality of SC administration. (read more)
    • Patient populations affected: Adults with R/R DLBCL (≥1 prior line), ineligible for HDT‑ASCT; global enrollment supports broad applicability. (read more)
  • Theme 2: ADC + Bispecific Combinations Drive Deep Responses
    • Significance: High response depth suggests synergy between tumor‑killing payloads and T‑cell redirection, positioning combinations for rapid adoption in chemo‑refractory LBCL. (read more)
    • Mechanism insights / clinical impact: ZYNLONTA (loncastuximab tesirine‑lpyl, CD19‑ADC) plus glofitamab (COLUMVI, CD20xCD3) achieved 89.8% ORR and 77.6% CR in LOTIS‑7 (n=49 efficacy‑evaluable), highlighting complementary targeting and immune activation. (read more)
    • Patient populations affected: R/R DLBCL, including heavily pretreated cohorts; enrollment expansion planned to ~100 patients at the selected dose, enabling broader confirmation. (read more)
  • Theme 3: Earlier‑Line, Chemo‑Sparing Strategies on Deck
    • Significance: Fixed‑duration and combination bispecific regimens could shift 1L/2L algorithms away from prolonged chemotherapy, expanding outpatient‑friendly options. (read more)
    • Mechanism insights / clinical impact: Ongoing Phase 3 trials—EPCORE DLBCL‑2 (epcoritamab + R‑CHOP, front‑line) and EPCORE DLBCL‑4 (epcoritamab + lenalidomide vs chemo in R/R)—aim for 2026 data, testing depth/durability with reduced chemo exposure. (read more)
    • Patient populations affected: Newly diagnosed DLBCL and R/R DLBCL across geographies; potential to benefit patients unfit for intensive approaches. (read more)
  • Theme 4: T‑Cell Lymphoma Innovation Spotlight (TCLF)
    • Significance: Dedicated forum focus signals rising investment to close outcome gaps vs B‑cell lymphomas. (read more)
    • Mechanism insights / clinical impact: Agenda emphasizes adoptive cellular therapies, therapeutic innovations, and CTCL management—catalyzing translation into disease‑specific trials. (read more)
    • Patient populations affected: PTCL subtypes (e.g., AITL, PTCL‑NOS, ENKTL) and CTCL patients needing novel, tolerable strategies. (read more)
  • Significance
    • Expected clinical or translational readouts: LOTIS‑5 (ZYNLONTA + rituximab in 2L+ DLBCL) topline 2Q26; EPCORE DLBCL‑2/‑4 readouts anticipated in 2026. (read more)
    • Regulatory or policy implications: AbbVie/Genmab to engage global regulators on EPCORE DLBCL‑1; ADCT signals sBLA path pending LOTIS‑5 outcome. (read more)
    • Potential shifts in standard of care: PFS‑positive bispecific monotherapy may compete with chemo‑based regimens in transplant‑ineligible R/R DLBCL; combination and fixed‑duration approaches could move earlier in care. (read more)
    • Strategic implications: Prioritize SC, outpatient‑amenable assets; invest in ADC‑bispecific platforms; prepare for label/compendia expansions that broaden community‑oncology access. (read more)
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in lymphoma updated from 2026-01-01 to 2026-01-31:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation--1-1-2
Not Yet Recruiting12311-3332
Recruiting3734611223158
Available-------
Approved for Marketing-------
Active, Not Recruiting191130-11-71
Completed514-1-11
Total73491071386274
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
BMS-986369 NCT06535399 COMPLETED A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment 2025-11-12
CC-486 (5-azacitidine), Romidepsin, Lenalidomide, Dexamethasone NCT04447027 COMPLETED A Phase 1 Study of Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies 2025-12-17
LP-108, LP-108 and azacitidine NCT04139434 COMPLETED A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination With Azacitidine in Subjects With Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML) 2025-12-19
Zanubrutinib, Venetoclax, PRT2527 NCT05665530 COMPLETED A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With Relapsed/Refractory Hematologic Malignancies 2026-01-21
Rituximab, Lenalidomide, Ibrutinib NCT03703167 COMPLETED Phase Ib Trial With Dose Expansion of the Bruton"s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab and Lenalidomide in Patients With Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL) and Refractory/Recurrent Secondary Central Nervous System Lymphoma (SCNSL) 2026-01-26
: UF-KURE19 CAR-T cells, Cyclophosphamide, Fludarabine NCT05400109 ACTIVE_NOT_RECRUITING A Phase 1/1b Multicenter, Open Label Study to Evaluate the Safety of UF-KURE19 Cells in Patients With B Cell Non-Hodgkin Lymphomas 2026-04-01
BYON4228 + Rituximab NCT05737628 ACTIVE_NOT_RECRUITING First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228 Alone and in Combination With Rituximab to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Relapsed/Refractory CD20 Positive B-cell Non-Hodgkin's Lymphoma (NHL) 2026-05
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
gemcitabine, : favezelimab/pembrolizumab, bendamustine NCT05508867 COMPLETED A Phase 2 Randomized Clinical Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008) 2026-01-08
Pembrolizumab, Ibrutinib, Fludarabine NCT03204188 COMPLETED A Phase II Study Of Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) 2026-01-09
Zanubrutinib NCT04116437 COMPLETED A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients With Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment With Ibrutinib and/or Acalabrutinib 2026-01-09
Nivolumab NCT04401774 COMPLETED Phase II Maintenance Trial of Nivolumab for Newly Diagnosed PCNSL Patients With Persistent Circulating Tumor DNA in the CSF After Completion of Methotrexate-Based First-Line Induction Chemotherapy 2026-01-22
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
LCZ, LCZ/AML 200 mg/5 mg, LCZ/AML 200 mg/10 mg, LCZ/AML 200 mg/2.5 mg NCT06236061 COMPLETED A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696/Amlodipine 200/2.5 mg, 200/5 mg and 200/10 mg Compared to LCZ696 200 mg Alone in Patients With Grade 1 and 2 Hypertension Not Adequately Controlled by LCZ696 200 mg Monotherapy 2025-12-23
Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT), Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy NCT03570892 ACTIVE_NOT_RECRUITING Tisagenlecleucel Versus Standard of Care in Adult Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma: A Randomized, Open Label, Phase III Trial (BELINDA) 2026-02-11
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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