28 Participants Needed

Tafasitamab + Lenalidomide for Non-Hodgkin's Lymphoma

KS
Overseen ByKim Sprenger
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently receiving or have recently received any investigational study agent, you may not be eligible to participate.

What data supports the effectiveness of the drug combination Tafasitamab and Lenalidomide for treating Non-Hodgkin's Lymphoma?

Research shows that the combination of Tafasitamab and Lenalidomide is effective for patients with relapsed or refractory diffuse large B-cell lymphoma, a type of Non-Hodgkin's Lymphoma. In a study, 57.5% of patients responded to the treatment, with 41.3% achieving complete response, and the treatment was well-tolerated with manageable side effects.12345

Is the combination of Tafasitamab and Lenalidomide safe for treating non-Hodgkin's lymphoma?

The combination of Tafasitamab and Lenalidomide has been shown to be generally safe and well-tolerated in patients with relapsed or refractory diffuse large B-cell lymphoma, with manageable side effects and no new safety concerns reported in long-term studies.12367

How is the drug combination of Tafasitamab and Lenalidomide unique for treating Non-Hodgkin's Lymphoma?

The combination of Tafasitamab and Lenalidomide is unique because it targets CD19 on cancer cells and enhances the immune response, offering a new option for patients with relapsed or refractory diffuse large B-cell lymphoma who cannot undergo stem cell transplants. This combination has shown promising long-term benefits and manageable side effects, making it a novel approach compared to other treatments.12458

What is the purpose of this trial?

The purpose of the study is to evaluate the safety and efficacy of tafasitamab and lenalidomide in participants with Large B Cell Lymphoma (LBCL) after axicabtagene ciloleucel (axi-cel) treatment. Participants will be asked to spend about 12 months in this study.

Research Team

FL

Frederick Locke, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for individuals with Large B Cell Lymphoma who have previously undergone axicabtagene ciloleucel treatment. Participants will be involved in the study for approximately 12 months.

Inclusion Criteria

My PET/CT shows my disease is stable or partially improved after recent CAR-T therapy.
I am able to get out of my bed or chair and move around.
Baseline Oxygen Saturation >92% on room air
See 7 more

Exclusion Criteria

My heart is affected by lymphoma.
I have an autoimmune disease that has caused organ damage or needed strong medication in the last 2 years.
Patients who are currently receiving or who have received any investigational study agent ≤4 weeks prior to the screening visit are ineligible
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tafasitamab intravenously weekly for the first three 28-day cycles and every 2 weeks starting at Cycle 4. Lenalidomide is taken daily for 21 days out of each 28-day cycle for 6 cycles.

6 months
Weekly visits for the first 3 months, bi-weekly visits thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Lenalidomide
  • Tafasitamab
Trial Overview The safety and effectiveness of combining two drugs, Tafasitamab and Lenalidomide, are being tested as a first salvage therapy option for patients with LBCL after initial treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Tafasitamab and Lenalidomide TreatmentExperimental Treatment2 Interventions
Participants will receive the study drug, Tafasitamab, intravenously on a weekly basis for the first three 28-day cycles (Cycles 1-3) and then every 2 weeks starting at Cycle 4 onwards. Participants will take the study drug, Lenalidomide, once daily for 21 days out of each 28-day cycle for 6 cycles.

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Incyte Corporation

Industry Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Findings from Research

In the final 5-year analysis of the L-MIND study involving 80 patients with relapsed/refractory diffuse large B-cell lymphoma, the combination of tafasitamab and lenalidomide showed a significant objective response rate of 57.5%, with a complete response rate of 41.3%.
The treatment demonstrated long-term clinical benefits, with a median overall survival of 33.5 months and manageable adverse events, indicating that this immunotherapy combination is both effective and well-tolerated.
Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety in the phase II L-MIND study.Duell, J., Abrisqueta, P., Andre, M., et al.[2023]
In a phase 2 study involving 81 patients with relapsed or refractory diffuse large B-cell lymphoma, the combination of tafasitamab and lenalidomide resulted in a 60% objective response rate, with 43% achieving a complete response, indicating significant antitumor activity.
The treatment was generally well tolerated, although serious adverse events occurred in 51% of patients, with neutropenia being the most common, suggesting that while effective, monitoring for side effects is important.
Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study.Salles, G., Duell, J., González Barca, E., et al.[2020]
In the RE-MIND2 study, patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) treated with tafasitamab plus lenalidomide showed significantly prolonged overall survival compared to those receiving standard systemic therapies, with a hazard ratio of 0.55.
When specifically compared to bendamustine plus rituximab and rituximab plus gemcitabine/oxaliplatin, tafasitamab plus lenalidomide demonstrated even greater survival benefits, with hazard ratios of 0.42 and 0.47, respectively, indicating its potential as a more effective treatment option.
Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study.Nowakowski, GS., Yoon, DH., Peters, A., et al.[2023]

References

Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety in the phase II L-MIND study. [2023]
Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. [2020]
Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study. [2023]
The use of tafasitamab in diffuse large B-cell lymphoma. [2023]
Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. [2021]
Tafasitamab: First Approval. [2022]
Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study. [2023]
RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma. [2023]
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