✦ Cancer Clinical Trials

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Jul 06 – Jul 13, 2026

MRD-negativity by PBMCs and ctDNA confirms deep and durable responses following epcoritamab monotherapy in R/R FL.
BLOOD ADV · Q1 JOURNAL - RANK #13/98
This abstract evaluates minimal residual disease (MRD) negativity as a marker of deep and durable responses following epcoritamab monotherapy in relapsed/refractory follicular lymphoma (R/R FL) using data from the EPCORE NHL-1 prospective clinical trial (NCT03625037). MRD status was assessed using the clonoSEQ assay on peripheral blood mononuclear cells (PBMCs) and circulating tumor DNA (ctDNA) at prespecified time points. Key findings include rapid conversion to MRD-negativity by cycle 3 day 1 (C3D1), which correlated with prolonged progression-free survival (PFS; median not reached) regardless of radiographic response. The authors conclude that MRD-negativity complements conventional response assessment and may inform future clinical trial design.
10.1182/bloodadvances.2025017565

Pharmacologic activity, safety, and preliminary efficacy of GEN3009, a CD37-targeting DuoHexaBody, in relapsed or refractory B-cell non-Hodgkin’s lymphoma.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
To evaluate safety and efficacy of GEN3009 (DuoHexaBody-CD37), a phase 1 dose-escalation trial enrolled 46 adults with R/R B-cell non-Hodgkin’s lymphoma. This open-label, multicenter, first-in-human study used a modified Bayesian optimal interval design to identify the recommended phase 2 dose (RP2D). In participants treated up to 1600 mg, no dose-limiting toxicities were observed, with neutropenia (89.1%), infusion-related reactions (84.8%), and thrombocytopenia (39.1%) as the most common adverse events. Preliminary data showed an acceptable safety profile, a 1200 mg RP2D, and modest clinical activity correlated with changes in complement levels (p=0.008).
10.1136/jitc-2025-014311

Phase I/Ib study evaluating safety, efficacy, pharmacokinetics and pharmacodynamics of NIZ985 monotherapy and in combination with an anti-PD-1 agent in patients with advanced solid tumors or lymphoma.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
This open-label, multicenter phase I/Ib trial (NCT04261439) prospectively enrolled patients with advanced solid tumors or lymphoma who had previously received anti-PD-1 therapy to evaluate NIZ985, an IL-15 heterodimer, as monotherapy or combined with PD-1 inhibitors through dose-escalation and expansion cohorts. Patients received weekly subcutaneous NIZ985 at 8, 12, or 16 µg/kg, either alone or with spartalizumab/tislelizumab; safety endpoints included cycle-1 dose-limiting toxicities, full adverse-event profiling, and pharmacokinetic/pharmacodynamic assessments. Injection-site reactions, pyrexia, and transaminase increases were the most common adverse events; dose adjustments or interruptions were more frequent at 16 µg/kg, and exposure rose proportionally with dose while remaining unaffected by checkpoint blockade. The recommended dose for expansion was established at 12 µg/kg weekly (3 weeks-on/1 week-off), and although biological activity was observed, antitumor responses were limited in this heavily pretreated, PD-1-refractory population.
10.1016/j.ejca.2026.116899

Orelabrutinib versus chemoimmunotherapy in treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma: a randomized, phase 3 trial.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This randomized, phase 3 trial evaluated the efficacy and safety of orelabrutinib versus chlorambucil plus rituximab in 192 treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients. At a median follow-up of 21.4 months, orelabrutinib significantly improved progression-free survival (not reached vs. 19.4 months, HR 0.32, 95% CI: 0.18-0.58, p<0.0001), overall response rate (90.1% vs. 79.2%, p=0.041), and duration of response (HR 0.30, 95% CI: 0.15-0.60, p=0.0003) compared to chemoimmunotherapy. Treatment-related adverse events occurred with similar frequency in both groups, but fewer grade 3 or worse events were reported in the orelabrutinib group (35.2% vs. 60.2%). These findings support orelabrutinib as a safe and effective first-line treatment for CLL/SLL patients, with improved efficacy and manageable safety compared to chemoimmunotherapy.
10.1038/s41392-026-02818-x

Jun 29 – Jul 06, 2026

A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of NHWD-870 HCl in Patients with Lymphoma and Other Advanced Solid Tumors.
RECENT PAT ANTI-CANC · Q1 JOURNAL - RANK #79/352
This study is a phase I open-label, dose-escalation clinical trial exploring NHWD-870 HCl, an oral BET inhibitor, in patients with lymphoma and advanced solid tumors. Conducted across multiple centers using a Bayesian optimal interval design, the study evaluated safety, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended phase II dose (RP2D), identifying 2.0 mg (5 days on/2 days off schedule) as RP2D due to manageable hematologic toxicity. Among 31 enrolled patients, 93.5% experienced at least one adverse event; dose/escalation-related thrombocytopenia was the primary toxicity factor, while efficacy showed a low Objective Response Rate (3.45%) but a promising Disease Control Rate (69.0%). The study concludes that NHWD-870 HCl demonstrated preliminary signs of efficacy in BET-dependent tumors and warrants further biomarker-driven evaluation, especially in diseases like NUT carcinoma and diffuse large B cell lymphoma (DLBCL).
10.2174/0115748928447241260617103928

Photobiomodulation to prevent oral mucositis and physical function impairments after hematopoietic cell transplantation: POMFITT randomized trial.
SUPPORT CARE CANCER · Q1 JOURNAL - RANK #17/173
The study evaluated the effectiveness of photobiomodulation versus standard care in preventing oral mucositis and functional impairment in 30 adults undergoing hematopoietic cell transplantation (HCT) for hematologic malignancies, using a randomized controlled trial design. The intervention involved InGaIP diode laser treatment (660 nm and 808 nm wavelengths, 100 mW, administered three times weekly from conditioning day 1 to day +3), with outcomes measured via WHO oral mucositis scale, 2-min step test, Jamar dynamometer, Sit-to-Stand test, and FACT-BMT. Severe oral mucositis occurred in 26.6% of controls versus 0% in the intervention group (p=0.032), but no significant differences were observed in hospitalization days, handgrip strength, aerobic capacity, or lower-limb strength. The study concluded that photobiomodulation reduced severe oral mucositis incidence without impacting physical function or quality of life, with high patient acceptance (93.3% rated 10/10).
10.1007/s00520-026-10970-x

A novel dose-dense strategy for CD19-directed CAR T-cell therapy is associated with durable responses without increased toxicity in patients with B-cell non-Hodgkin lymphoma.
HAEMATOLOGICA · Q1 JOURNAL - RANK #11/98
This phase 1/2 pilot cohort of the JCAR014 study (NCT01865617) evaluated a novel dose-dense CD19-directed CAR T-cell regimen in 20 patients with relapsed/refractory B-cell non-Hodgkin lymphoma. After standard lymphodepletion, patients received two infusions of 2 × 10^6 CAR+ cells/kg, the second on day 14 without additional conditioning; 17 patients completed both infusions and were followed for up to eight years. Any-grade cytokine release syndrome occurred in 59% and neurotoxicity in 18%, almost exclusively after the first dose, while CAR T-cell re-expansion was seen in 94% post-second infusion; overall and complete response rates were 47% (8/17) and 41% (7/17), with a 63% 8-year durability among responders versus 26% in historical single-dose recipients. The authors conclude that early redosing is feasible, does not increase toxicity, and may enhance long-term remission rates in R/R B-NHL.
10.3324/haematol.2025.300321

Epcoritamab monotherapy or epcoritamab with lenalidomide as first-line therapy for patients with diffuse large B-cell lymphoma (EPCORE DLBCL-3): primary analysis of an open-label, multicentre, randomised, phase 2 trial.
LANCET HAEMATOL · Q1 JOURNAL - RANK #3/98TOP-TIER
This open-label, multicentre, randomised, phase 2 trial evaluated fixed-duration epcoritamab monotherapy versus epcoritamab with lenalidomide as first-line therapy for older adults with newly diagnosed diffuse large B-cell lymphoma ineligible for anthracycline-based chemoimmunotherapy, conducted across 44 hospitals in 11 countries. In stage 1, 88 patients were randomised (1:1), with a complete response rate of 63.6% (28/44) in the monotherapy group and 45.5% (20/44) in the combination group. Based on efficacy and safety, epcoritamab monotherapy was selected for stage 2, yielding a complete response rate of 45.5% (10/22) in stage 2 and 57.6% (38/66) across both stages, with manageable safety. The authors conclude that fixed-duration epcoritamab monotherapy shows promising efficacy and warrants continued investigation as a chemotherapy-free first-line option.
10.1016/S2352-3026(26)00112-2

Phase I/II Study of Sonrotoclax (BGB-11417) Monotherapy in Patients With Mantle Cell Lymphoma Previously Treated With Anti-CD20 Therapy and a Bruton Tyrosine Kinase Inhibitor.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This phase I/II trial evaluated sonrotoclax monotherapy in 125 patients with relapsed/refractory mantle cell lymphoma previously treated with anti-CD20 therapy and a Bruton tyrosine kinase inhibitor. The open-label, global study (NCT05471843) used a 4-week ramp-up to 160 mg or 320 mg daily doses to mitigate tumor lysis syndrome. Key efficacy results showed an overall response rate of 52.4% (95% CI 42.4-62.4, p<0.0001 vs historic control) and a complete response rate of 15.5%, with median progression-free survival of 6.5 months. Sonrotoclax demonstrated rapid, durable responses and manageable safety, supporting further evaluation in this heavily pretreated population.
10.1200/JCO-26-00550

Jun 22 – Jun 29, 2026

Ten-Year Outcomes after CAR T-Cell Therapy for B-Cell Lymphomas.
NEW ENGL J MED · Q1 JOURNAL - RANK #2/332TOP-TIER
This prospective clinical trial evaluated the 10-year outcomes of 38 patients with relapsed or refractory B-cell non-Hodgkin lymphomas (24 with large B-cell lymphoma, 14 with follicular lymphoma) treated with CTL019 (tisagenlecleucel) CAR T-cell therapy. The study reported 10-year lymphoma-free survival rates of 32% (95% CI, 14-51) for large B-cell lymphoma and 47% (95% CI, 20-71) for follicular lymphoma, with no relapses beyond 5.4 years. Key findings included a 21% cumulative incidence of second primary cancers and 18% non-relapse-related mortality, while persistent grade 2/3 neutropenia occurred in 5% of patients. The study concludes that tisagenlecleucel can induce decade-long remissions in a substantial proportion of heavily pretreated patients, with CAR-transgene persistence potentially linked to long-term response.
10.1056/NEJMoa2518035

Jun 15 – Jun 22, 2026

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.
AM J HEMATOL · Q1 JOURNAL - RANK #10/98
This phase 2 multicenter clinical trial evaluated the efficacy and safety of the CARiBOU regimen—a combination of VR-CAP, R-cytarabine, and continuous acalabrutinib—for previously untreated mantle cell lymphoma patients in six 21-day cycles. The primary endpoint was the complete metabolic response (CMR) rate, achieved by 90% (37/41) of patients, with secondary outcomes including progression-free survival (18-month estimated PFS 79% [95% CI 64–97%]) and overall survival (OS 96% [95% CI 88–100%]), as well as measurable residual disease rates (79–94%). The study reported significant hematologic toxicity but no treatment-related deaths, and feasibility of stem-cell collection was assessed. The authors conclude that CARiBOU provides efficient, effective first-line therapy, with MRD-guided consolidation options and robust response rates.
10.1002/ajh.70406

Liposomal mitoxantrone plus tislelizumab in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma: a phase 1b/2 trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This phase 1b/2 prospective clinical trial evaluated the safety and efficacy of liposomal mitoxantrone combined with tislelizumab in 40 patients with relapsed or refractory extranodal natural killer/T-cell lymphoma, utilizing a 3+3 dose-escalation followed by dose-expansion at the recommended phase 2 dose. No dose-limiting toxicities were identified, and the CR rate reached 53% (21/40; one-sided 95% lower confidence bound, 38%), with median progression-free survival of 8.2 months (95% CI, 6.1-not estimable) after a median follow-up of 15.3 months. The most common grade ≥ 3 adverse events included leukopenia (53%), neutropenia (40%), and febrile neutropenia (18%). The study concludes that this regimen demonstrates promising anti-tumor activity and acceptable safety in this population.
10.1038/s41467-026-74483-1

Jun 08 – Jun 15, 2026

CD19/CD22 bivalent CAR T cells in children, adolescents and young adults with B-ALL: final phase 1 trial results.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This phase 1 clinical trial evaluated a bivalent CD19.22.BBζ CAR T-cell therapy in children, adolescents, and young adults (n=30; 28 B-ALL, 2 Burkitt) treated at the recommended phase 2 dose. Safety outcomes showed CRS in 20/28 B-ALL patients (71.4%; grade 3 in 2/20 [10%]) and grade 3 ICANS in 3/28 (10.7%); one patient’s CRS resolved with first-line siltuximab. Efficacy included measurable residual disease–negative complete remission in 25/28 B-ALL patients (89.3%), with 23/28 (82.1%) proceeding directly to HSCT a median 51 days post-infusion (range 45–68). Median relapse-free survival among responders was not reached; median overall survival for all 28 patients was 34 months (95% CI 17–NE), supporting this construct as an effective bridge to HSCT and highlighting non‑CNS extramedullary disease as a barrier to response.
10.1136/jitc-2026-015296

Obinutuzumab, lenalidomide, and venetoclax for the initial treatment of patients with advanced-stage follicular lymphoma: Results of the Phase Ib/II LEVERAGE study.
HEMASPHERE · Q1 JOURNAL - RANK #5/98TOP-TIER
This Phase Ib/II prospective interventional study evaluated the initial treatment of advanced-stage, high tumor burden follicular lymphoma using obinutuzumab, lenalidomide, and venetoclax with induction (6×28-day cycles) and response-adapted maintenance. Fifty treatment-naïve patients (median age 60) received venetoclax at four dose levels (up to 800 mg daily, selected for Phase II), obinutuzumab throughout induction, and lenalidomide from cycles 2–6; ctDNA-based NGS was used for genomic characterization and MRD monitoring. The complete response rate was 86% and objective response rate 92%; at 18.3 months median follow-up, 2-year progression-free and overall survival were 92% and 100%, respectively, with common adverse events including neutropenia (72%), diarrhea (52%), and upper respiratory infection (48%). Undetectable MRD after one cycle had a 95% negative predictive value for relapse, while detectable MRD after three cycles had a 75% positive predictive value; the regimen was active but limited by myelosuppression.
10.1002/hem3.70386

A first-in-class bifunctional antibody targeting CD20 and CD37 remodels the immune microenvironment in relapsed or refractory B-cell malignancies.
J HEMATOL ONCOL · Q1 JOURNAL - RANK #1/98TOP-TIER
This multicenter, open-label phase Ia study (NCT05003141) prospectively evaluated dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), safety, pharmacokinetics, pharmacodynamics, and efficacy of PSB202, a novel bifunctional antibody co-targeting CD20/CD37 in relapsed/refractory CD20+ B-cell non-Hodgkin lymphoma. Fifteen heavily pretreated adults (median age 67.7) received 12–300 mg PSB202, resulting in one grade 4 neutropenia DLT at 100 mg and no MTD established. The overall response rate was 30% in 10 evaluable patients, including one complete response at the 300 mg dose, with grade ≥3 neutropenia and leukopenia in 60% of patients. PSB202 showed a manageable safety profile, induced sustained B-cell depletion and IFN-γ release without cytokine release syndrome, and demonstrated potential for dual targeting of malignant B cells while mitigating CD3-related toxicity, supporting further clinical development.
10.1186/s13045-026-01796-5

Jun 01 – Jun 08, 2026

The long-term efficacy and safety of high-dose chemotherapy with autologous stem cell transplantation in the treatment of primary central nervous system lymphoma: A real-world report from the Polish Lymphoma Research Group.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
This prospective observational study evaluated the efficacy and safety of high-dose chemotherapy (carmustine, etoposide, thiotepa) followed by autologous stem-cell transplantation in 60 transplant-eligible primary CNS lymphoma patients treated across five Polish hemato-oncology centers. Patients first underwent R-MIV induction therapy and an AT cycle before HDC-ASCT, with a median age of 58 years. The 4-year progression-free and overall survival rates were 66% and 74%, respectively, with 3.3% transplant-related mortality and 25% relapse rate. The strategy was feasible and safe, and outcomes during the COVID-19 pandemic did not differ significantly from non-pandemic periods.
10.1016/j.ejca.2026.116789

May 25 – Jun 01, 2026

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.
LANCET · Q1 JOURNAL - RANK #1/332TOP-TIER
This phase 3, randomised, double-blind, placebo-controlled multicentre clinical trial evaluated tafasitamab plus lenalidomide added to standard R-CHOP versus R-CHOP alone as first-line treatment for untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) in 899 adult patients. Patients received six 21-day cycles with stratified random assignment; progression-free survival was the primary endpoint. At median follow-up of 35.2 months, the tafasitamab-lenalidomide-R-CHOP group had a hazard ratio for progression-free survival of 0.75 (95% CI 0.59-0.96, p=0.0194) and a 2-year progression-free survival rate of 71.1% versus 62.9% for R-CHOP alone; grade 3 or higher adverse events were more frequent with tafasitamab-lenalidomide-R-CHOP (87% vs 76%). The trial concluded tafasitamab-lenalidomide-R-CHOP may offer a new first-line option, but with increased adverse event rates.
10.1016/S0140-6736(26)00866-4