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NCT05464329 · ClinicalTrials.gov registry record · Phase 1
Mosunetuzumab in Combination With Platinum-Based Salvage Chemotherapy in Patients With Relapsed/Refractory Aggressive B Cell Lymphoma
A Phase 1 study of Large B-cell Lymphoma and High Grade B-Cell Lymphoma, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05464329: Active Phase 1 study of Large B-cell Lymphoma and High Grade B-Cell Lymphoma, sponsored by Washington University School of Medicine.
NCT05464329 is a Phase 1 study of Large B-cell Lymphoma and High Grade B-Cell Lymphoma that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 24 participants, below the 158-participant average among 28 other Large B-cell Lymphoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05464329, a Phase 1 study of Large B-cell Lymphoma and High Grade B-Cell Lymphoma, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a two-arm, open-label, phase Ib single-site study with expansion cohorts testing the addition of mosunetuzumab to intensive platinum-based salvage chemotherapy in patients with relapsed/refractory aggressive B cell lymphoma. The hypothesis of this study is that mosunetuzumab can be safely combined with platinum-based salvage chemotherapy in this patient population, and that this approach may outperform chemoimmunotherapy approaches that instead incorporate rituximab retreatment. The enrolling physician's choice of the chemotherapy backbone will determine a patient's assigned study arm (Arm A = DHAX, Arm B = ICE). The two arms will accrue patients to phase Ib independently.
Primary Outcome
-Treatment-emergent adverse events (TEAE) are defined as adverse events possibly, probably, or definitely related to mosunetuzumab that occur on or after first dose of study treatment.
Conditions Studied
Interventions
- DRUG Mosunetuzumab
- DRUG DHAX
- DRUG ICE
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-01-03 |
| Est. Completion | 2029-10-16 |
| Phase | Phase 1 |
What the registry record for NCT05464329 still lists
NCT05464329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 158-participant average among 28 other Large B-cell Lymphoma trials with a reported enrollment target (85% lower).
The record links to 4 conditions, with Large B-cell Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Mosunetuzumab is the first listed.
NCT05464329 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05464329 about?
NCT05464329 is a clinical study titled "Mosunetuzumab in Combination With Platinum-Based Salvage Chemotherapy in Patients With Relapsed/Refractory Aggressive B Cell Lymphoma". This is a two-arm, open-label, phase Ib single-site study with expansion cohorts testing the addition of mosunetuzumab to intensive platinum-based salvage chemotherapy in patients with relapsed/refractory aggressive B cell lymphoma. The hypothesis of this study is that mosunetuzumab can be safely co...
What is the current status of trial NCT05464329?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-01-03. Estimated completion is 2029-10-16.
What conditions does trial NCT05464329 study?
This clinical trial studies the following conditions: Large B-cell Lymphoma, High Grade B-Cell Lymphoma, Follicular Lymphoma Grade 3B, Transformed B-Cell Lymphoma.
What interventions are being tested in trial NCT05464329?
The interventions under investigation include: Mosunetuzumab (DRUG), DHAX (DRUG), ICE (DRUG).
Who is sponsoring clinical trial NCT05464329?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05464329 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05464329's enrollment target sits among peer trials
24 23rd of 28 higher than 5 of 28 other Large B-cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Large B-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.
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