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NCT04703192 · ClinicalTrials.gov registry record · Phase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
A Phase 2 study of Adult T-cell Leukemia/Lymphoma and Relapsed/Refractory Peripheral T-cell Lymphoma, sponsored by Daiichi Sankyo.
- Active
- Registry status
- Phase 2
- Development phase
- 155
- Enrollment target
- 20
- Study locations
NCT04703192: Active Phase 2 study of Adult T-cell Leukemia/Lymphoma and Relapsed/Refractory Peripheral T-cell Lymphoma, sponsored by Daiichi Sankyo.
NCT04703192 is a Phase 2 study of Adult T-cell Leukemia/Lymphoma and Relapsed/Refractory Peripheral T-cell Lymphoma that is active but no longer recruiting, run by Daiichi Sankyo. The registered enrollment target is 155 participants, above the 34-participant average among 8 other Adult T-cell Leukemia/Lymphoma trials with a reported enrollment target (356% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04703192, a Phase 2 study of Adult T-cell Leukemia/Lymphoma and Relapsed/Refractory Peripheral T-cell Lymphoma, is active but no longer recruiting, sponsored by Daiichi Sankyo.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 155 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.
Primary Outcome
For the relapsed/refractory peripheral T-cell lymphoma (PTCL) cohort, objective response rate (ORR) is defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), assessed by blinded independent central review (BICR), among participants with centrally confirmed PTCL eligible histology.
Conditions Studied
Interventions
- DRUG Valemetostat Tosylate
Study Locations (20)
Other
- Epworth Healthcare - Richmond
- Ottawa Hospital Research Institute - Ottawa
- University Health Network Princess Margaret Hospital - Toronto
- CHU de Dijon - Dijon
- CHRU de Lille - Hôpital Claude Huriez - Maladies du Sang - Lille
California
- City Of Hope National Medical Center - Duarte
- Stanford University Medical Center - Cancer Clinical Trials Office - ONCOLOGY - Palo Alto
- University of California San Francisco - San Francisco
New York
- Memorial Sloan-Kettering Cancer Center at Memorial Hospital - New York
- Weill Cornell Medicine - New York
Colorado
- University Of Colorado Cancer Center - Aurora
Georgia
- Emory University Hospital - Winship Cancer Institute - Atlanta
Illinois
- Northwestern University - Feinberg School of Medicine - Chicago
Massachusetts
- Dana Farber Cancer Institute - Boston
Minnesota
- Mayo Clinic - Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2021-06-03 |
| Est. Completion | 2027-02-19 |
| Phase | Phase 2 |
What the registry record for NCT04703192 still lists
NCT04703192 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 34-participant average among 8 other Adult T-cell Leukemia/Lymphoma trials with a reported enrollment target (356% higher).
The record links to 2 conditions, with Adult T-cell Leukemia/Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Valemetostat Tosylate is the first listed.
NCT04703192 names 20 study sites across 13 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT04703192 about?
NCT04703192 is a clinical study titled "Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)". This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.
What is the current status of trial NCT04703192?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2021-06-03. Estimated completion is 2027-02-19.
What conditions does trial NCT04703192 study?
This clinical trial studies the following conditions: Adult T-cell Leukemia/Lymphoma, Relapsed/Refractory Peripheral T-cell Lymphoma.
What interventions are being tested in trial NCT04703192?
The interventions under investigation include: Valemetostat Tosylate (DRUG).
Who is sponsoring clinical trial NCT04703192?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04703192 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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