Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT04626791
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    Given PO
  • Bortezomib — DRUG
    Given SC
  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IV
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Rituximab and Hyaluronidase Human — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Aug 3, 2021
Status verified
Aug 2023
Primary completion
Aug 3, 2024
Completion
Aug 3, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (modified VR-CAP, acalabrutinib)
    CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Proportion of complete responses to therapy (complete metabolic response [CMR]) [ Time Frame: At completion of study treatment ]

Locations (7)

FacilityCityStateZIPSite coordinators
Ochsner NCI Community Oncology Research ProgramNew OrleansLouisiana70121-
Metropolitan-Mount Sinai Medical CenterMinneapolisMinnesota55404-
Mount Sinai HospitalNew YorkNew York10029-
Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth Carolina28203
ACCRU Operation
[email protected]
507-538-7448
Steven I. Park (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
University of Washington Medical Center - MontlakeSeattleWashington98195
Stephen D. Smith
[email protected]
Stephen D. Smith (PRINCIPAL_INVESTIGATOR)
Aurora Cancer Care-Milwaukee WestWauwatosaWisconsin53226-

Find similar trials in New Orleans, LA

By research site
Ochsner NCI Community Oncology Research Program· New Orleans, LAMetropolitan-Mount Sinai Medical Center· Minneapolis, MNMount Sinai Hospital· New York, NYCarolinas Medical Center/Levine Cancer Institute· Charlotte, NCFred Hutchinson Cancer Research Center· Seattle, WAUniversity of Washington Medical Center - Montlake· Seattle, WA

Related Studies