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NCT04626791
Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma
Phase 2 trial testing Acalabrutinib in Mantle Cell Lymphoma in 45 participants. Currently enrolling.
3 August 2024
Quick facts
| Lead sponsor | Academic and Community Cancer Research United |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 3 August 2021 |
| Primary completion | 3 August 2024 |
| Estimated completion | 3 August 2028 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- Acalabrutinib (ACALABRUTINIB) — full drug profile →
- Bortezomib (bortezomib) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Cytarabine
- Doxorubicin Hydrochloride — full drug profile →
- Prednisone (prednisone) — full drug profile →
- Rituximab
- Rituximab and Hyaluronidase Human
Conditions studied
- Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →
Sponsor
Academic and Community Cancer Research United — full company profile →
Who can join
Adults 18 to 75, any sex, with Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04626791
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Acalabrutinib
Trials testing the same drug.
- NCT07257055 — Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WIN · Phase 2 · recruiting
- NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
- NCT07024706 — Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2 · Phase 2 · not yet recruiting
- NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies · not yet recruiting
- NCT07014917 — Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL · Phase 2 · recruiting
Other recruiting trials for Mantle Cell Lymphoma
Currently open trials in the same condition.
- NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
- NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
- NCT06839053 — Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic L · Phase 2 · recruiting
- NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial · Phase 1, PHASE2 · recruiting
- NCT06854003 — BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Fo · Phase 2 · recruiting
Other Academic and Community Cancer Research United trials
Trials by the same sponsor.
- NCT06160206 — Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma · Phase 2 · recruiting
- NCT06238648 — Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed · Phase 2 · recruiting
- NCT05910801 — Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma · Phase 2 · recruiting
- NCT05356897 — Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molec · Phase 2 · withdrawn
- NCT05194293 — Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04626791 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Academic and Community Cancer Research United
- Last refreshed: 12 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04626791.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing