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NCT05994235 · ClinicalTrials.gov registry record · Phase 2
Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma
A Phase 2 study of Follicular Lymphoma, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05994235: Recruiting Phase 2 study of Follicular Lymphoma, sponsored by Weill Medical College of Cornell University.
NCT05994235 is a Phase 2 study of Follicular Lymphoma that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 50 participants, below the 135-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05994235, a Phase 2 study of Follicular Lymphoma, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to learn about the safety and effectiveness of the combination of tazemetostat pills in combination with mosunetuzumab injections for people with follicular lymphoma who haven't received treatment before. The investigators hypothesize that tazemetostat with mosunetuzumab has the potential to increase the efficacy of the product without compromising the safety. Tazemetostat is a drug that inhibits EZH2, an enzyme known to drive the development of B-cell lymphomas, and inhibiting it appears to have many effects that slow down lymphoma growth and enhance the immune system's ability to fight it. Tazemetostat is FDA-approved in previously treated follicular lymphoma and currently undergoing study in other lymphomas. Mosunetuzumab is a bispecific antibody therapy that is a therapeutic strategy that uses the immune system to fight lymphoma, called immunotherapy. Bispecific antibodies have two ends: one attaches to T cells in the immune system and the other attaches to lymphoma cells, helping guide our immune system to attack the cancer. Mosunetuzumab has been studied in follicular lymphoma that has previously been treated, with positive results. Mosunetuzumab is approved by the FDA to be given intravenously (directly into a vein) but is not yet approved by the FDA is not yet approved as an injection under the skin, which is how it is given in this study. They have not yet been studied in combination.
Primary Outcome
The proportion of patients who achieve complete response as per the Lugano criteria will be calculated and their 90% confidences will be computed with Clopper-Pearson method via exact binomial distribution.
Conditions Studied
Interventions
- DRUG Mosunetuzumab
- DRUG Tazemetostat Pill
Study Locations (1)
New York
- Weill Cornell Medicine/NewYork-Presbyterian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2033-10 |
| Phase | Phase 2 |
What NCT05994235 shows while recruiting
NCT05994235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 135-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Follicular Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Mosunetuzumab is the first listed.
NCT05994235 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05994235 about?
NCT05994235 is a clinical study titled "Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma". The goal of this study is to learn about the safety and effectiveness of the combination of tazemetostat pills in combination with mosunetuzumab injections for people with follicular lymphoma who haven't received treatment before. The investigators hypothesize that tazemetostat with mosunetuzumab ha...
What is the current status of trial NCT05994235?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2023-11-01. Estimated completion is 2033-10.
What conditions does trial NCT05994235 study?
This clinical trial studies the following conditions: Follicular Lymphoma.
What interventions are being tested in trial NCT05994235?
The interventions under investigation include: Mosunetuzumab (DRUG), Tazemetostat Pill (DRUG).
Who is sponsoring clinical trial NCT05994235?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05994235 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Follicular 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 NCT05994235's enrollment target sits among peer trials
50 44th of 89 higher than 44 of 89 other Follicular Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Follicular 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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