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NCT04626791 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Mantle Cell Lymphoma, sponsored by Academic and Community Cancer Research United.

Recruiting
Registry status
Phase 2
Development phase
45
Enrollment target
7
Study locations

NCT04626791: Recruiting Phase 2 study of Mantle Cell Lymphoma, sponsored by Academic and Community Cancer Research United.

NCT04626791 is a Phase 2 study of Mantle Cell Lymphoma that is actively recruiting participants, run by Academic and Community Cancer Research United. The registered enrollment target is 45 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (57% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04626791, a Phase 2 study of Mantle Cell Lymphoma, is actively recruiting participants, sponsored by Academic and Community Cancer Research United.

RECRUITING
Registry status
Phase 2
Development phase
45 participants
Enrollment target
7
Study locations

Study 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.

Primary Outcome

Measured according to Lugano criteria. A success is defined as a CMR as the objective status at the end of treatment. The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Conditions Studied

Mantle Cell Lymphoma

Interventions

  • DRUG Cyclophosphamide
  • DRUG Doxorubicin Hydrochloride
  • DRUG Cytarabine
  • DRUG Acalabrutinib
  • DRUG Bortezomib

Study Locations (7)

Washington

  • Fred Hutchinson Cancer Research Center - Seattle
  • University of Washington Medical Center - Montlake - Seattle

Louisiana

  • Ochsner NCI Community Oncology Research Program - New Orleans

Minnesota

  • Metropolitan-Mount Sinai Medical Center - Minneapolis

New York

  • Mount Sinai Hospital - New York

North Carolina

  • Carolinas Medical Center/Levine Cancer Institute - Charlotte

Wisconsin

  • Aurora Cancer Care-Milwaukee West - Wauwatosa

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2021-08-03
Est. Completion 2028-08-03
Phase Phase 2
Academic and Community Cancer Research United

42 total trials

What NCT04626791 shows while recruiting

NCT04626791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (57% lower).

The record links to 1 condition, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT04626791 lists 7 locations in 6 states (Washington, Louisiana, Minnesota).

Frequently Asked Questions

What is clinical trial NCT04626791 about?

NCT04626791 is a clinical study titled "Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma". 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...

What is the current status of trial NCT04626791?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2021-08-03. Estimated completion is 2028-08-03.

What conditions does trial NCT04626791 study?

This clinical trial studies the following conditions: Mantle Cell Lymphoma.

What interventions are being tested in trial NCT04626791?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Cytarabine (DRUG), Acalabrutinib (DRUG), Bortezomib (DRUG).

Who is sponsoring clinical trial NCT04626791?

This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04626791 being conducted?

This trial has 7 study locations across Louisiana, Minnesota, New York, North Carolina, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Mantle Cell Lymphoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04626791's enrollment target sits among peer trials

45 48th of 102 higher than 52 of 102 other Mantle Cell Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Mantle Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04626791

Source: ClinicalTrials.gov NCT04626791, the US trial registry maintained by the National Library of Medicine. NCT04626791 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.