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NCT04659044 · ClinicalTrials.gov registry record · Phase 2
Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
A Phase 2 study, sponsored by Academic and Community Cancer Research United.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT04659044: Clinical Trial Phase 2 study, sponsored by Academic and Community Cancer Research United.
NCT04659044 is a Phase 2 study that was terminated before completion, run by Academic and Community Cancer Research United. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04659044, a Phase 2 study, was terminated before completion, sponsored by Academic and Community Cancer Research United.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This phase II trial studies the effect of polatuzumab vedotin, venetoclax, and rituximab and hyaluronidase human in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cell growth. Rituximab hyaluronidase is a combination of rituximab and hyaluronidase. Rituximab binds to a molecule called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Hyaluronidase allows rituximab to be given by injection under the skin. Giving rituximab and hyaluronidase by injection under the skin is faster than giving rituximab alone by infusion into the blood. Giving polatuzumab vedotin, venetoclax, and rituximab and hyaluronidase human may work better than standard therapy in treating patients with mantle cell lymphoma.
Primary Outcome
Objective status of CR measured by positron emission tomography (PET)-computed tomography (CT) scans according to Lugano 2014.
Interventions
- DRUG Venetoclax
- BIOLOGICAL Rituximab
- DRUG Polatuzumab Vedotin
- BIOLOGICAL Rituximab and Hyaluronidase Human
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2024-03-29 |
| Phase | Phase 2 |
Why NCT04659044 stopped before completion
NCT04659044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which Venetoclax is the first listed.
NCT04659044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04659044 about?
NCT04659044 is a clinical study titled "Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma". This phase II trial studies the effect of polatuzumab vedotin, venetoclax, and rituximab and hyaluronidase human in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, link...
What is the current status of trial NCT04659044?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2021-04-01. Estimated completion is 2024-03-29.
What interventions are being tested in trial NCT04659044?
The interventions under investigation include: Venetoclax (DRUG), Rituximab (BIOLOGICAL), Polatuzumab Vedotin (DRUG), Rituximab and Hyaluronidase Human (BIOLOGICAL).
Who is sponsoring clinical trial NCT04659044?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04659044's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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