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NCT02232516 · ClinicalTrials.gov registry record · Phase 2
Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma
A Phase 2 study of Peripheral T-Cell Lymphoma and Anaplastic Large Cell Lymphoma, sponsored by Northwestern University.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 5
- Study locations
NCT02232516: Active Phase 2 study of Peripheral T-Cell Lymphoma and Anaplastic Large Cell Lymphoma, sponsored by Northwestern University.
NCT02232516 is a Phase 2 study of Peripheral T-Cell Lymphoma and Anaplastic Large Cell Lymphoma that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 30 participants, below the 105-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (71% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02232516, a Phase 2 study of Peripheral T-Cell Lymphoma and Anaplastic Large Cell Lymphoma, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma (PTCL) who have not been previously treated for this cancer. Currently, there is no standard treatment for patients with PTCL; the most common treatment used is a combination of drugs called CHOP, but this can be a difficult treatment to tolerate because of side effects, and is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug affects how tumor cells grow and survive, including affecting blood vessel growth in tumors. It is given as an oral tablet (by mouth).
Primary Outcome
The endpoint for this objective will be objective response rate (ORR), defined per Cheson criteria. Response will be assessed by imaging after cycles 3 and 6, and then every 6 months thereafter. Response at 3 months (after cycle 3) will be used for purposes of the interim efficacy analysis.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG lenalidomide
- DRUG romidepsin
Study Locations (5)
California
- City of Hope - Duarte
Connecticut
- Yale University - New Haven
Illinois
- Northwestern University - Chicago
New York
- Weill Cornell Medicine - New York
Washington
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-06-11 |
| Est. Completion | 2024-08 |
| Phase | Phase 2 |
What the registry record for NCT02232516 still lists
NCT02232516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 105-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (71% lower).
The record links to 10 conditions, with Peripheral T-Cell Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT02232516 lists 5 locations in 5 states (California, Connecticut, Illinois).
Frequently Asked Questions
What is clinical trial NCT02232516 about?
NCT02232516 is a clinical study titled "Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma". The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma (PTCL) who have not been previously treated for this cancer. Currently, there is no standard treatment for patients ...
What is the current status of trial NCT02232516?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2015-06-11. Estimated completion is 2024-08.
What conditions does trial NCT02232516 study?
This clinical trial studies the following conditions: Peripheral T-Cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Hepatosplenic T-cell Lymphoma.
What interventions are being tested in trial NCT02232516?
The interventions under investigation include: laboratory biomarker analysis (OTHER), lenalidomide (DRUG), romidepsin (DRUG).
Who is sponsoring clinical trial NCT02232516?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02232516 being conducted?
This trial has 5 study locations across California, Connecticut, Illinois, New York, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02232516's enrollment target sits among peer trials
30 21st of 34 higher than 13 of 34 other Peripheral T-Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral T-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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