Actively Recruiting
Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Led by Academic and Community Cancer Research United · Updated on 2024-11-18
100
Participants Needed
2
Research Sites
364 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
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.
CONDITIONS
Official 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 specific genetic markers or cyclin D1 overexpression
- Relapsed or refractory mantle cell lymphoma after at least one prior systemic treatment
- Preserved CD19 expression if relapsed/refractory after prior anti-CD19 therapy unless biopsy is not feasible
- Need for treatment due to lymphoma symptoms or blood count abnormalities
- Measurable disease with lymph nodes >= 1.5 cm, spleen size >= 15 cm, or high white blood cell count
- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- Adequate blood cell counts and liver and kidney function within 14 days prior to registration
- Negative pregnancy test within 7 days prior to registration for women of reproductive potential
- Agreement to use effective contraception during and after treatment as specified
- Willingness to enroll in the REVLIMID REMS program
- Ability to take low-dose aspirin daily or an alternative anticoagulant
- Ability to provide informed consent within 28 days prior to registration
- Willingness to return for follow-up during active monitoring
- Willingness to provide blood samples for research
You will not qualify if you...
- Pregnant or nursing persons (nursing persons may participate if they agree not to breastfeed during treatment and for 3 months after)
- Men or women unwilling to use adequate contraception during treatment and specified post-treatment periods
- Autologous stem cell transplant within 90 days prior to registration
- Allogeneic stem cell transplant
- Anti-CD19 CAR T-cell therapy within 90 days prior to registration
- Central nervous system involvement by mantle cell lymphoma
- Receiving other treatments for mantle cell lymphoma except corticosteroids
- Recent use of certain anticoagulants or medications affecting drug metabolism within specified timeframes
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days before registration or planned use during study
- HIV positive status
- Chronic hepatitis B or C requiring treatment or active infection
- Severe co-morbid illnesses or uncontrolled illnesses including advanced heart failure, recent heart attack or stroke, and serious lung diseases
- Ongoing inflammatory bowel disease requiring treatment
- Conditions preventing oral drug intake
- Psychiatric or social conditions limiting study compliance
- Recent major surgery or live vaccination
- Life-threatening blood clotting or bleeding disorders
- Other active primary cancers requiring treatment or with limited expected survival
- Inability to swallow oral medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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