RecruitingPhase 2NCT05910801

Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Tafasitamab, Lenalidomide and Venetoclax Combination Therapy for Relapsed or Refractory Mantle Cell Lymphoma (V-MIND): a Phase II Study with Safety Lead-In


Sponsor

Academic and Community Cancer Research United

Enrollment

100 participants

Start Date

Jan 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well tafasitamab, lenalidomide and venetoclax work in treating patients with mantle cell lymphoma that has come back (after a period of improvement) (relapsed) or that has not responded to previous treatment (refractory). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving tafasitamab, lenalidomide and venetoclax together may kill cancer cells more efficiently in patients with relapsed or refractory mantle cell lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — tafasitamab, lenalidomide, and venetoclax — for people with mantle cell lymphoma (a type of blood cancer) that has returned or stopped responding to prior treatment. **You may be eligible if...** - You are 18 or older with confirmed mantle cell lymphoma - Your lymphoma has come back or has not responded to at least one prior treatment - You are in need of treatment based on your doctor's assessment - Your blood counts and organ function are within acceptable ranges - You are willing to use effective contraception and comply with the study's medication safety program (REMS) **You may NOT be eligible if...** - You have had a recent stem cell transplant (within 90 days) or CAR T-cell therapy (within 90 days) - You have lymphoma in the brain or spinal cord - You are currently receiving other lymphoma treatment (excluding steroids) - You have HIV, active hepatitis B or C - You have significant heart disease (recent heart attack, severe heart failure) - You are pregnant or unwilling to use contraception - You cannot swallow oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT scan

DRUGLenalidomide

Given PO

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET/CT scan

BIOLOGICALTafasitamab

Given IV

DRUGVenetoclax

Given PO


Locations(2)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05910801


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