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NCT04569032 · ClinicalTrials.gov registry record · Phase 2
A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression
A Phase 2 study of Peripheral T-Cell Lymphoma, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 20
- Study locations
NCT04569032: Completed Phase 2 study of Peripheral T-Cell Lymphoma, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
NCT04569032 is a Phase 2 study of Peripheral T-Cell Lymphoma that has completed, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 82 participants, below the 104-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04569032, a Phase 2 study of Peripheral T-Cell Lymphoma, has completed, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 20
- Study locations
Study Summary
This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.
Primary Outcome
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) following the completion of study treatment (at end of treatment \[EOT\]). CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
Conditions Studied
Interventions
- DRUG prednisone
- DRUG cyclophosphamide
- DRUG doxorubicin
- DRUG brentuximab vedotin
Study Locations (20)
Colorado
- Rocky Mountain Cancer centers, LLP - Aurora
- Rocky Mountain Cancer centers, LLP - Boulder
- Rocky Mountain Cancer centers, LLP - Colorado Springs
- Rocky Mountain Cancer centers, LLP - Denver
- Rocky Mountain Cancer centers, LLP - Denver
- Rocky Mountain Cancer centers, LLP - Lakewood
- Rocky Mountain Cancer centers, LLP - Littleton
- Rocky Mountain Cancer centers, LLP - Lone Tree
- Rocky Mountain Cancer centers, LLP - Longmont
- Rocky Mountain Cancer centers, LLP - Pueblo
- Rocky Mountain Cancer centers, LLP - Thornton
Alabama
- University of Alabama at Birmingham - Birmingham
- University of Alabama at Birmingham - Birmingham
California
- Stanford Cancer Center - Stanford
- Stanford Hospital and Clinics, Investigational Drug Services - Stanford
Louisiana
- Tulane Cancer Center - New Orleans
- Tulane Medical Center - New Orleans
New York
- Memorial Sloan Kettering Cancer Center David H. Koch Center for Cancer Care - New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cleveland Clinic taussig Cancer Center Investigational Pharmacy - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2020-11-12 |
| Est. Completion | 2026-01-12 |
| Phase | Phase 2 |
What the finished NCT04569032 record still lists
NCT04569032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 104-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (21% lower).
The record links to 1 condition, with Peripheral T-Cell Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which prednisone is the first listed.
NCT04569032 names 20 study sites across 6 states, led by Colorado, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT04569032 about?
NCT04569032 is a clinical study titled "A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression". This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do b...
What is the current status of trial NCT04569032?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2020-11-12. Estimated completion is 2026-01-12.
What conditions does trial NCT04569032 study?
This clinical trial studies the following conditions: Peripheral T-Cell Lymphoma.
What interventions are being tested in trial NCT04569032?
The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), doxorubicin (DRUG), brentuximab vedotin (DRUG).
Who is sponsoring clinical trial NCT04569032?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04569032 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04569032's enrollment target sits among peer trials
82 12th of 34 higher than 22 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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