Actively Recruiting
Tafasitamab, Lenalidomide and Venetoclax Combination Therapy for Relapsed or Refractory Mantle Cell Lymphoma (V-MIND) Phase II Study with Safety Lead-In
Led by Academic and Community Cancer Research United ยท Updated on 2024-11-18
100
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Academic and Community Cancer Research United
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well a combination of tafasitamab, lenalidomide, and venetoclax works to treat patients with mantle cell lymphoma that has returned after improvement or did not respond to previous treatments. This phase II study focuses on this combination therapy for relapsed or refractory mantle cell lymphoma, aiming to understand its effects on cancer cell growth and patient outcomes. Tafasitamab is a monoclonal antibody, lenalidomide helps the immune system target cancer cells, and venetoclax blocks a protein that cancer cells need to survive. Patients in the study receive tafasitamab intravenously and take lenalidomide and venetoclax by mouth while participating. Before starting treatment, some patients may undergo a lumbar puncture. Throughout the study, they will have CT scans, blood samples, and possibly MRI scans and tumor biopsies. PET/CT scans, bone marrow biopsies, and aspirates are also performed regularly. After completing treatment, participants are followed up every three months for one year, then every four months for a second year, and every six months up to five years total. During the trial, patients will be closely monitored with imaging tests and lab work to assess their response to the therapy and check safety. Researchers will measure outcomes like the overall response rate, complete response rate, duration of response, progression-free survival, overall survival, and any adverse events. Participants will provide blood samples for research and agree to follow-up visits to track their health for up to five years after starting the study.
CONDITIONS
Brief Title
Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of mantle cell lymphoma with t(11;14) translocation or cyclin D1 overexpression
- Relapsed or refractory disease with at least one prior systemic treatment
- Preserved CD19 expression if previously treated with anti-CD19 therapy, unless biopsy is unsafe
- In need of treatment due to symptoms or cytopenia
- At least one measurable lesion (lymph node or spleen size) or elevated white blood cell count
- ECOG Performance Status 0, 1, or 2
- Absolute neutrophil count at least 1500/mm3
- Platelet count at least 75,000/mm3 (or 50,000/mm3 if bone marrow involved)
- Hemoglobin greater than 8.0 g/dL
- Coagulation times (aPTT/PTT and PT/INR) within 1.5 times the upper normal limit
- Liver function tests (bilirubin, ALT, AST) within specified limits
- Creatinine clearance above 60 ml/min
- Negative pregnancy test for women of reproductive potential
- Agreement to use effective contraception during and after treatment
- Willingness to enroll in the REVLIMID REMS program
- Ability to take low-dose aspirin or alternative anticoagulation
- Signed informed consent within 28 days prior to registration
- Willing to return for follow-up and provide blood specimens for research
You will not qualify if you...
- Pregnant or nursing persons (unless agreeing not to breastfeed during and after treatment)
- Men or women unwilling to use adequate contraception during and after treatment
- Recent autologous stem cell transplant (within 90 days)
- Allogeneic stem cell transplant at any time
- Recent anti-CD19 CAR T-cell therapy (within 90 days)
- CNS involvement by mantle cell lymphoma
- Receiving other treatments for mantle cell lymphoma except corticosteroids
- Recent use of certain anticoagulants or interacting medications
- Use of grapefruit, Seville oranges, or star fruit near registration
- HIV positive
- Active hepatitis B or C infection requiring treatment
- Severe concurrent illnesses or uncontrolled heart conditions
- Oxygen-dependent lung disease
- Active inflammatory bowel disease requiring treatment
- Malabsorption syndrome or inability to take oral drugs
- Active infections
- Psychiatric or social situations limiting compliance
- Recent stroke, heart attack, major surgery, or live vaccination
- Life-threatening blood clotting or bleeding conditions
- Other active cancers requiring treatment or limiting survival
- Unable to swallow oral medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants receive tafasitamab intravenously, lenalidomide orally, and venetoclax orally during the treatment period. They undergo CT scans and blood sample collections, and may have MRI and tumor biopsies. They also undergo PET/CT scans, bone marrow biopsies, and bone marrow aspirations throughout the study.
Regular visits for treatment and assessments throughout the study
Duration - Up to 5 years after treatment
After treatment completion, participants are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months until up to 5 years after entering the trial. During follow-up, participants may undergo MRI, tumor biopsy, PET/CT, bone marrow biopsy, and bone marrow aspirate assessments.
Visits every 3 months for 1 year, then every 4 months for 1 year, then every 6 months up to 5 years
Trial Site Locations
Total: 2 locations
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
I
Inbox Mayo Clinic Cancer Studies
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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