Rituximab and Pembrolizumab With or Without Lenalidomide in Treating Patients With Relapsed Follicular Lymphoma and Diffuse Large B-Cell Lymphoma
Active, enrolledPhase 2Results postedLast updated 9 March 2026
What this trial tests
Phase 2 trial testing Laboratory Biomarker Analysis in Recurrent Diffuse Large B-Cell Lymphoma in 53 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Recurrent Diffuse Large B-Cell Lymphoma or Recurrent Grade 1 Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (Complete + Partial Responses)Primary· Approximately 1 year and 6 months
To determine the overall response rate (ORR) in subjects with relapsed follicular lymphoma (FL) treated with Rituximab plus pembrolizumab therapy. II. To determine the ORR in subjects with relapsed/refractory FL and relapsed/refractory diffuse large B-Cell lymphoma (DLBCL) who failed chimeric antigen receptor (CAR) T cell therapy and rea treated with rituximab in combination with pembrolizumab and lenalidomide (Cohort 2)
Complete Response (CR)
Group
Value
95% CI
Cohort I (Rituximab, Pembrolizumab)
15
Cohort II (Rituximab, Pembrolizumab, Lenalidomide)
5
Partial Response (PR)
Group
Value
95% CI
Cohort I (Rituximab, Pembrolizumab)
5
Cohort II (Rituximab, Pembrolizumab, Lenalidomide)
0
Not Evaluable
Group
Value
95% CI
Cohort I (Rituximab, Pembrolizumab)
0
Cohort II (Rituximab, Pembrolizumab, Lenalidomide)
2
Progressive Disease (PD)
Group
Value
95% CI
Cohort I (Rituximab, Pembrolizumab)
0
Cohort II (Rituximab, Pembrolizumab, Lenalidomide)
7
Adverse events — posted to ClinicalTrials.gov
Time frame: Approximately 1 year and 6 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort I (Rituximab, Pembrolizumab)
Serious: 7/30 (23%)
Deaths: 0/30
Cohort II (Rituximab, Pembrolizumab, Lenalidomide)
This phase II trial studies how well rituximab and pembrolizumab with or without lenalidomide works in treating patients with follicular lymphoma and diffuse large B-cell lymphoma that has returned after a period of improvement. Immunotherapy with monoclonal antibodies, such as rituximab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rutuximab with pembrolizumab and lenalidomide may work better at treating follicular lymphoma and diffuse large B-cell lymphoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04142398 — Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men
· withdrawn
NCT04142385 — Incidence of HIV Infection in Screening Indian Men Who Have Sex With Men
· withdrawn
NCT05558904 — An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cance
· Phase 1, PHASE2
· recruiting
NCT05564650 — Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome
· Phase 1
· active not recruiting
NCT05396859 — Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia
· Phase 1
· active not recruiting
Other recruiting trials for Recurrent Diffuse Large B-Cell Lymphoma
Currently open trials in the same condition.
NCT07042438 — Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Expo
· Phase 2
· recruiting
NCT06859008 — Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Rel
· Phase 1
· recruiting
NCT07098364 — ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma
· Phase 1, PHASE2
· recruiting
NCT06649812 — Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggress
· Phase 2
· recruiting
NCT06784726 — Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T
· Phase 2
· recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem
· Phase 1, PHASE2
· not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and
· Phase 1
· not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che
· Phase 2
· not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca
· Phase 2
· not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 9 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02446457.