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NCT05091424 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase 1 study of Chronic Lymphocytic Leukemia, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 137
- Enrollment target
- 20
- Study locations
NCT05091424: Recruiting Phase 1 study of Chronic Lymphocytic Leukemia, sponsored by Hoffmann-La Roche.
NCT05091424 is a Phase 1 study of Chronic Lymphocytic Leukemia that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 137 participants, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05091424, a Phase 1 study of Chronic Lymphocytic Leukemia, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 137 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first two cycles of mosunetuzumab. An additional arm (open to non-US participants only) has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) inhibitor.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Mosunetuzumab
- DRUG Tocilizumab
Study Locations (20)
Other
- Peking University People's Hospital - Beijing
- Southern Medical University Nanfang Hospital - Guangzhou
- The First Affiliated Hospital of Nanchang University - Nanchang
- Tianjin Institute of Hematology & Blood Diseases Hospital - Tianjin
- Chu de Clermont Ferrand - Clermont-Ferrand
- IUCT Oncopole - Toulouse
- Universitätsklinikum Augsburg - Augsburg
- Uniklinik Koln - Cologne
- Universitätsklinikum Ulm - Ulm
Lombardy
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili - Brescia
- Osp. San Raffaele - Milan
- Asst Grande Ospedale Metropolitano Niguarda - Milan
Victoria
- Peter MacCallum Cancer Center - East Melbourne
- Monash Medical Centre - Melbourne
Minnesota
- Mayo Clinic Rochester - Rochester
New York
- Memorial Sloan-Kettering Cancer Center - New York
Ohio
- The James Cancer Hospital and Solove Research Institute - Columbus
Texas
- Uni of Texas - Md Anderson Cancer Center - Houston
Utah
- Huntsman Cancer Institute at The University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2030-02-28 |
| Phase | Phase 1 |
What NCT05091424 shows while recruiting
NCT05091424 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT05091424 names 20 study sites across 9 states, led by Other, Lombardy, Victoria.
Frequently Asked Questions
What is clinical trial NCT05091424 about?
NCT05091424 is a clinical study titled "A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia". This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). This study will also allow participants who are currently progressing on a Bruton t...
What is the current status of trial NCT05091424?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 137 participants. The study started on 2022-03-07. Estimated completion is 2030-02-28.
What conditions does trial NCT05091424 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT05091424?
The interventions under investigation include: Venetoclax (DRUG), Mosunetuzumab (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT05091424?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05091424 being conducted?
This trial has 20 study locations across Minnesota, New York, Ohio, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
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 NCT05091424's enrollment target sits among peer trials
137 54th of 187 higher than 134 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia 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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