OncoMatch/Clinical Trials/NCT04626791
Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma
Is NCT04626791 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for mantle cell lymphoma.
Treatment: Acalabrutinib · Bortezomib · Cyclophosphamide · Cytarabine · Doxorubicin Hydrochloride · Prednisone · Rituximab · Rituximab and Hyaluronidase Human — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: systemic therapy
Exception: Short course of steroids (<= 7 days) for symptom management or localized radiation is permissible, as long as measurable disease outside of the radiation field exists
Prior systemic treatment for mantle cell lymphoma. Short course of steroids (<= 7 days) for symptom management or localized radiation is permissible, as long as measurable disease outside of the radiation field exists
Cannot have received: proteasome inhibitor (bortezomib)
Prior exposure to bortezomib or a BTK inhibitor
Cannot have received: BTK inhibitor
Prior exposure to bortezomib or a BTK inhibitor
Cannot have received: anthracycline
Exception: unless cumulative prior exposure is under 150 mg per square meter
Prior anthracycline exposure unless cumulative prior exposure is under 150 mg per square meter
Lab requirements
Blood counts
ANC >= 1000/mm^3 or >= 500/mm^3 if due to lymphomatous marrow or spleen involvement; Platelet count >= 100,000/mm^3 or >= 75,000/mm^3 if due to lymphomatous marrow or spleen involvement
Kidney function
Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 x ULN (unless documented Gilbert's syndrome, for which total bilirubin <= 3 x ULN is permitted); AST <= 3 x ULN; PT/INR or PTT <= 2 x ULN, unless elevated due to a lupus anticoagulant
Absolute neutrophil count (ANC) >= 1000/mm^3 or >= 500/mm^3 if due to lymphomatous marrow or spleen involvement; Platelet count >= 100,000/mm^3 or >= 75,000/mm^3 if due to lymphomatous marrow or spleen involvement; Total bilirubin <= 1.5 x ULN (unless documented Gilbert's syndrome, for which total bilirubin <= 3 x ULN is permitted); Aspartate transaminase (AST) <= 3 x ULN; Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) <= 2 x ULN, unless elevated due to a lupus anticoagulant; Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ochsner NCI Community Oncology Research Program · New Orleans, Louisiana
- Metropolitan-Mount Sinai Medical Center · Minneapolis, Minnesota
- Mount Sinai Hospital · New York, New York
- Carolinas Medical Center/Levine Cancer Institute · Charlotte, North Carolina
- Fred Hutchinson Cancer Research Center · Seattle, Washington
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04626791 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages