Actively Recruiting
Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma
Led by Academic and Community Cancer Research United · Updated on 2024-03-12
45
Participants Needed
7
Research Sites
365 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 investigates how well modified VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, and cytarabine hydrochloride) and acalabrutinib as first line therapy work in treating transplant-eligible patients with mantle cell lymphoma. Modified VR-CAP is a combination of drugs used as standard first line treatment for mantle cell lymphoma. Chemotherapy drugs, such as bortezomib, cyclophosphamide, doxorubicin hydrochloride, and cytarabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that binds and depletes malignant B cells, by inducing immune responses and direct toxicity. Acalabrutinib blocks a key enzyme which is needed for malignant cell growth in mantle cell lymphoma. Combining modified VR-CAP and acalabrutinib as first line therapy may be more useful against mantle cell lymphoma compared to the usual treatment.
CONDITIONS
Official Title
Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- No prior therapy for mantle cell lymphoma
- Mantle cell lymphoma requiring systemic therapy and potentially eligible for autologous stem cell transplant
- Histological confirmation of mantle cell lymphoma
- Measurable disease with at least one lesion 1.5 cm or larger on PET/CT or splenomegaly >13 cm
- ECOG performance status of 0, 1, or 2
- Adequate neutrophil and platelet counts, accounting for marrow or spleen involvement
- Total bilirubin within 1.5 times upper limit of normal (or up to 3 times if Gilbert's syndrome)
- AST less than or equal to 3 times upper limit of normal
- Coagulation tests within 2 times upper limit of normal unless due to lupus anticoagulant
- Creatinine clearance of 30 ml/min or higher
- Negative pregnancy test for women of childbearing potential within 14 days prior to registration
- Agreement to use highly effective contraception for women of childbearing potential during and 12 months after treatment
- Men agree to use barrier contraception during treatment and for 180 days after
- Ability to provide informed consent
- Willingness to return for follow-up visits
- Hematologic labs obtained within 14 days prior to registration
- Ability and willingness to participate in all study procedures
- Ability to understand study purpose and risks and provide consent
You will not qualify if you...
- Prior systemic treatment for mantle cell lymphoma except short steroid courses of 7 days or less or localized radiation
- Peripheral neuropathy or neuropathic pain grade 2 or higher
- Prior exposure to bortezomib or BTK inhibitors
- Prior anthracycline exposure exceeding 150 mg/m2
- Need for anticoagulation with warfarin or similar vitamin K antagonists
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
- Active bleeding or bleeding disorders such as hemophilia or von Willebrand disease
- Stroke or intracranial hemorrhage within 6 months before enrollment
- Requirement for treatment with strong CYP3A4 inhibitors or inducers
- Requirement for proton pump inhibitors (H2-receptor antagonists allowed)
- Allergic reactions to acalabrutinib, cytarabine, bortezomib, boron, or study agents
- Active worsening systemic infections needing intravenous antibiotics
- Active or uncontrolled hepatitis B or C infection; specific viral tests required
- Severe concurrent illness or recent major surgery within 2 weeks making participation unsafe
- Known HIV positive status
- Uncontrolled illnesses including severe heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Participation in other investigational treatment trials for this cancer
- Other active cancers within 2 years except certain localized skin, prostate, breast, or cervical cancers without ongoing treatment
- Pregnant or breastfeeding
- Difficulty swallowing oral medications or significant gastrointestinal disease affecting absorption
- Recent gastrointestinal ulcer diagnosed within 3 months unless due to lymphoma involvement
- Major surgery within 28 days before first dose without adequate recovery
- Concurrent participation in another therapeutic clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Ochsner NCI Community Oncology Research Program
New Orleans, Louisiana, United States, 70121
Withdrawn
2
Metropolitan-Mount Sinai Medical Center
Minneapolis, Minnesota, United States, 55404
Withdrawn
3
Mount Sinai Hospital
New York, New York, United States, 10029
Active, Not Recruiting
4
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
5
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Withdrawn
6
University of Washington Medical Center - Montlake
Seattle, Washington, United States, 98195
Actively Recruiting
7
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Withdrawn
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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