The future of immunotherapy for diffuse large B-cell lymphoma.
Johannes Duell, Jason Westin
https://pubmed.ncbi.nlm.nih.gov/39319495/Actively Recruiting
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
36
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the combination of four drugsmosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomidein adults with relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma DLBCL, types of B-cell non-Hodgkin lymphoma NHL. This phase II trial aims to determine the safety of this drug combination and measure how well it helps control the disease by assessing response rates and survival outcomes. The study will also explore changes in immune cells and the tumor environment after treatment. The trial includes a safety run-in phase where the tolerable doses of the four drugs are tested. Afterward, participants receive the established dose level in the dose expansion phase. Mosunetuzumab, polatuzumab vedotin, and tafasitamab are given intravenously through a vein, while lenalidomide is taken orally. The study groups involve participants receiving these drugs in combination as experimental treatment. The treatment schedule and dosing are based on findings from the safety testing phase. Participants will be closely monitored during the study with assessments to track treatment response and safety. The primary outcome measured is the best overall response rate over approximately one year. Researchers will evaluate effects on disease control and survival, as well as immune system changes. Participants must agree to various safety measures, including contraception and blood tests, and will be followed through the study duration until completion around 2027.
CONDITIONS
A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL
J
Jason Westin, MD, MS, FACP
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M.D. Anderson Cancer Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Investigational regimen | L‑MIND regimen (tafasitamab + lenalidomide) |
|---|---|---|
| What it is | A combined immunotherapy regimen of mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide evaluated in safety run‑in and dose expansion cohorts for relapsed B‑cell lymphoma | An approved combination of tafasitamab plus lenalidomide (L‑MIND) for transplant‑ineligible relapsed/refractory DLBCL |
| Role in trial | Investigational combination regimen being tested within this study (Safety Run‑In and Dose Expansion cohorts) | Not included in the study; provided here for clinical context |
| Purpose | Treatment of relapsed CD20‑positive B‑cell lymphoma after prior therapy | Treatment of relapsed/refractory DLBCL in patients not eligible for transplant |
| Administration | Combination of intravenous mosunetuzumab, polatuzumab vedotin, and tafasitamab, plus oral lenalidomide | Intravenous tafasitamab plus oral lenalidomide, as per L‑MIND regimen |
| Evidence stage | Early phase II evaluation; safety and overall response rate are being assessed | Longer clinical experience with demonstrated responses in R/R DLBCL, including real‑world effectiveness |
| Important risks | Combination includes multiple immunotherapy agents with overlapping toxicity risks; safety profile not yet fully characterized | Known side effects largely related to lenalidomide and infusion reactions; manageable with dose adjustments |
| Key limitations | Single‑arm design with no internal control group limits ability to determine relative benefit | Indirect comparisons only; L‑MIND efficacy comparisons must account for differences in patient populations and trial settings |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants receive mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide as part of the study treatment.
Multiple visits for infusions and assessments during treatment
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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Johannes Duell, Jason Westin
https://pubmed.ncbi.nlm.nih.gov/39319495/M.D. Anderson Cancer Center
Lead Sponsor