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NCT04783415 · ClinicalTrials.gov registry record · Phase 2
Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma
A Phase 2 study of Mantle Cell Lymphoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04783415: Active Phase 2 study of Mantle Cell Lymphoma, sponsored by City of Hope Medical Center.
NCT04783415 is a Phase 2 study of Mantle Cell Lymphoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 12 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04783415, a Phase 2 study of Mantle Cell Lymphoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the effects of acalabrutinib, umbralisib, and ublituximab in treating previously untreated mantle cell lymphoma. Acalabrutinib and umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Ublituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib and umbralisib with ublituximab may work better in treating mantle cell lymphoma.
Primary Outcome
Defined as the proportion of response-evaluable participants that achieve a CR at the end of the induction therapy. CR rate after the induction therapy was estimated by the proportion of response-evaluable patients achieving CR after the induction therapy, along with the 95% exact binomial confidence interval.
Conditions Studied
Interventions
- DRUG Acalabrutinib
- BIOLOGICAL Ublituximab
- DRUG Umbralisib
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-03-26 |
| Est. Completion | 2025-09-20 |
| Phase | Phase 2 |
What the registry record for NCT04783415 still lists
NCT04783415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Acalabrutinib is the first listed.
NCT04783415 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04783415 about?
NCT04783415 is a clinical study titled "Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma". This phase II trial studies the effects of acalabrutinib, umbralisib, and ublituximab in treating previously untreated mantle cell lymphoma. Acalabrutinib and umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Ublituximab is a monoclonal antibody t...
What is the current status of trial NCT04783415?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2021-03-26. Estimated completion is 2025-09-20.
What conditions does trial NCT04783415 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma.
What interventions are being tested in trial NCT04783415?
The interventions under investigation include: Acalabrutinib (DRUG), Ublituximab (BIOLOGICAL), Umbralisib (DRUG).
Who is sponsoring clinical trial NCT04783415?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04783415 being conducted?
This trial has 1 study location across California. 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 NCT04783415's enrollment target sits among peer trials
12 96th of 102 higher than 6 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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Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients
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