A Phase II Study of Modified VR-CAP and Acalabrutinib as First Line Therapy for Transplant-Eligible Patients With Mantle Cell Lymphoma
Academic and Community Cancer Research United
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine the proportion of complete metabolic responses according to Lugano criteria at the end of study therapy. SECONDARY OBJECTIVES: I. To evaluate the safety of this regimen. II. To determine the proportion of subjects proceeding to autologous stem cell transplant (ASCT). III. To determine the feasibility and results of stem cell mobilization and successful collection. IV. To determine the progression-free survival (PFS) and overall survival (OS) (event monitoring phase), assessed up to 2 years after registration. CORRELATIVE RESEARCH OBJECTIVE: I. To asses…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18-75 years * No prior therapy for mantle cell lymphoma (MCL) * MCL in need of systemic therapy, and potentially eligible for ASCT as assessed by the treating physician * Documented histological confirmation of MCL by local institutional review * Documented, fludeoxyglucose F-18 (FDG)-avid measurable disease (at least 1 lesion \>= 1.5 cm in diameter) as detected by positron emission tomography (PET)/computed tomography (CT) and as defined and includes measurable nodal and extranodal disease sites, or splenomegaly measuring more than 13 cm in vertical length * Eastern…
Interventions
- DrugAcalabrutinib
Given PO
- DrugBortezomib
Given SC
- DrugCyclophosphamide
Given IV
- DrugCytarabine
Given IV
- DrugDoxorubicin Hydrochloride
Given IV
- DrugPrednisone
Given PO
- BiologicalRituximab
Given IV
Locations (7)
- Ochsner NCI Community Oncology Research ProgramNew Orleans, Louisiana
- Metropolitan-Mount Sinai Medical CenterMinneapolis, Minnesota
- Mount Sinai HospitalNew York, New York
- Carolinas Medical Center/Levine Cancer InstituteCharlotte, North Carolina
- Fred Hutchinson Cancer Research CenterSeattle, Washington
- University of Washington Medical Center - MontlakeSeattle, Washington