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Immunomodulatory Agent
Tafasitamab + Lenalidomide + Venetoclax for Mantle Cell Lymphoma (V-MIND Trial)
Phase 2
Recruiting
Led By Yucai Wang
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests how tafasitamab, lenalidomide & venetoclax can help kill cancer cells in people with mantle cell lymphoma.
Who is the study for?
Adults with relapsed or refractory mantle cell lymphoma, who've had at least one prior treatment and have measurable disease. They must be in relatively good health, with adequate blood counts and organ function, not pregnant, willing to use contraception, and able to take daily aspirin or anticoagulants. Excluded are those recently receiving certain treatments like stem cell transplants or CAR T-cell therapy, those with CNS involvement by MCL or severe concurrent diseases.
What is being tested?
The trial is testing a combination of three drugs: tafasitamab (a monoclonal antibody), lenalidomide (an immunomodulatory agent), and venetoclax (a Bcl-2 inhibitor) for treating mantle cell lymphoma that has returned after treatment or hasn't responded to previous therapies. The goal is to see if this drug combo can more effectively kill cancer cells.
What are the potential side effects?
Potential side effects include reactions related to the immune system's increased activity against cancer cells which may affect normal cells too. This could lead to fatigue, digestive issues, blood count changes; there might also be risks associated with each specific drug such as infections due to lowered immunity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rate
Secondary study objectives
Complete response rate
Duration of response
Incidence of adverse events (AE)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (Tafasitamab, lenalidomide, venetoclax)Experimental Treatment11 Interventions
Patients receive tafasitamab IV, lenalidomide PO and venetoclax PO while on study. Patients may undergo lumbar puncture during screening. Patients undergo CT scan and blood sample collection and may undergo MRI and tumor biopsy on study and during follow-up. Patients undergo PET/CT, bone marrow biopsy, and bone marrow aspirate throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumbar Puncture
2016
Completed Phase 3
~510
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Computed Tomography
2017
Completed Phase 2
~2740
Lenalidomide
2005
Completed Phase 3
~2240
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Positron Emission Tomography
2011
Completed Phase 2
~2200
Tafasitamab
2016
Completed Phase 3
~630
Venetoclax
2019
Completed Phase 3
~2200
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,365 Total Patients Enrolled
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
4,841 Total Patients Enrolled
Yucai WangPrincipal InvestigatorAcademic and Community Cancer Research United
2 Previous Clinical Trials
95 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am not taking any medications that affect CYP3A4.I do not have any severe illnesses besides my current condition.I am HIV positive or have chronic hepatitis B/C needing treatment.My MCL cancer still shows CD19 presence after previous treatment, unless a biopsy is risky for me.My condition worsened or didn't improve after at least one treatment.I cannot take low-dose aspirin or blood thinners due to bleeding issues.I am currently taking or have recently used blood thinners or specific enzyme affecting drugs.I am of childbearing age and not willing to use birth control.I have had a stroke, heart attack, major surgery, live vaccine, or serious blood clot.My disease can be measured by the size of lymph nodes, lesions, spleen, or white blood cell count.I do not have any uncontrolled illnesses like heart or lung diseases.I am not pregnant.I can take low-dose aspirin or another blood thinner daily.I cannot swallow pills.I can take care of myself and perform daily activities.I have signed the consent form for this trial within the last 28 days.I am willing to come back for check-ups and give blood for research.I do not have another cancer that needs treatment or affects my survival.My lymphoma diagnosis is confirmed with specific genetic features.I have recently had treatments like stem cell transplants or CAR T-cell therapy for my cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Tafasitamab, lenalidomide, venetoclax)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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