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NCT03946878 · ClinicalTrials.gov registry record · Phase 2
Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
A Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03946878: Active Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, sponsored by M.D. Anderson Cancer Center.
NCT03946878 is a Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 32 participants, below the 37-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target (14% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03946878, a Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well venetoclax and acalabrutinib work in treating patients with mantle cell lymphoma that did not respond to previous treatment or has come back. Venetoclax may cause cancer cell death by blocking the mechanism that cancer cells use to stay alive. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax and acalabrutinib together may kill more cancer cells in patients with mantle cell lymphoma.
Primary Outcome
Assessed by Lugano criteria - positron emission tomography (PET)-computed tomography, and in a subset of patients by bone marrow flow cytometry, circulating tumor deoxyribonucleic acid and endoscopy if at baseline there is gut involvement. Response will be calculated separately with and without knowledge of the PET result by International Working Group criteria, in order to provide context in relation to historical control data. Will estimate the CR along with the 95% credible interval.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Acalabrutinib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-08-13 |
| Est. Completion | 2028-02-08 |
| Phase | Phase 2 |
What the registry record for NCT03946878 still lists
NCT03946878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 37-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target (14% lower).
The record links to 9 conditions, with Recurrent Mantle Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT03946878 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03946878 about?
NCT03946878 is a clinical study titled "Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma". This phase II trial studies how well venetoclax and acalabrutinib work in treating patients with mantle cell lymphoma that did not respond to previous treatment or has come back. Venetoclax may cause cancer cell death by blocking the mechanism that cancer cells use to stay alive. Acalabrutinib may s...
What is the current status of trial NCT03946878?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2019-08-13. Estimated completion is 2028-02-08.
What conditions does trial NCT03946878 study?
This clinical trial studies the following conditions: Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma, CD20 Positive, Blastoid Variant Mantle Cell Lymphoma, Pleomorphic Variant Mantle Cell Lymphoma.
What interventions are being tested in trial NCT03946878?
The interventions under investigation include: Venetoclax (DRUG), Acalabrutinib (DRUG).
Who is sponsoring clinical trial NCT03946878?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03946878 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent 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 NCT03946878's enrollment target sits among peer trials
32 14th of 27 higher than 14 of 27 other Recurrent Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent 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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