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NCT06072131 · ClinicalTrials.gov registry record · Phase 3
To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
A Phase 3 study of Peripheral T-Cell Lymphoma, sponsored by Acrotech Biopharma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 504
- Enrollment target
- 20
- Study locations
NCT06072131: Recruiting Phase 3 study of Peripheral T-Cell Lymphoma, sponsored by Acrotech Biopharma.
NCT06072131 is a Phase 3 study of Peripheral T-Cell Lymphoma that is actively recruiting participants, run by Acrotech Biopharma. The registered enrollment target is 504 participants, above the 91-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (454% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06072131, a Phase 3 study of Peripheral T-Cell Lymphoma, is actively recruiting participants, sponsored by Acrotech Biopharma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 504 participants
- Enrollment target
- 20
- Study locations
Study Summary
Part 1: This is a 5 Arm study primarily to determine the best dose out of the two dose levels of Belinostat and Pralatrexate combined with CHOP/COP in newly diagnosed PTCL patients based on Safety for part 2 study. Part 2 (Efficacy and Safety): This is a 3 Arm study. Patients with previously untreated PTCL will be randomized 1:1:1 into 1 of 3 treatment groups: 2 experimental treatment groups (Bel-CHOP or Fol-COP) or 1 active comparator treatment group (CHOP). Patients will be treated for up to 6 cycles. The primary objective is to compare the Progression Free Survival of patients with newly diagnosed PTCL treated for up to 6 cycles with Beleodaq (belinostat) in combination with CHOP (Bel-CHOP) or Folotyn (pralatrexate injection) in combination with COP (Fol-COP) to CHOP alone.
Primary Outcome
Progression-free survival is determined from randomization to the first documented Progression of Disease or death, whichever occurs first.
Conditions Studied
Interventions
- DRUG CHOP
- DRUG Belinostat Injection
- DRUG Pralatrexate Injection
- DRUG COP
Study Locations (20)
Other
- Universitatsmedizin Gottingen - Göttingen
- Universitaetsklinikum Halle (Saale) - Halle
- Semmelweis Egyetem - Budapest
- National Institute of Oncology - Budapest
- Markhot Ferenc Oktato Korhaz - Eger
Texas
- Valley Cancer Associates - Harlingen
- Houston Methodist Hospital - Houston
- University of Texas, MD Anderson Cancer Center - Houston
- Baylor Scott & White Medical Center - Temple - Temple
California
- University of California, San Francisco Fresno - Clovis
- University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600 - Santa Monica
Ontario
- The Ottawa Hospital - Ottawa
- Princess Margaret Hospital - Toronto
Colorado
- University of Colorado School of Medicine - Aurora
Florida
- Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute - Pembroke Pines
Kentucky
- Norton Cancer Institute - Louisville
Michigan
- Henry Ford Health System - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 504 participants |
| Start Date | 2023-10-04 |
| Est. Completion | 2030-11 |
| Phase | Phase 3 |
What NCT06072131 shows while recruiting
NCT06072131 is an interventional study that assigns participants to a tested intervention. The registered 504 participants enrollment target is mid-sized for trials with a published cap, above the 91-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (454% higher).
The record links to 1 condition, with Peripheral T-Cell Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which CHOP is the first listed.
NCT06072131 names 20 study sites across 11 states, led by Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT06072131 about?
NCT06072131 is a clinical study titled "To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL". Part 1: This is a 5 Arm study primarily to determine the best dose out of the two dose levels of Belinostat and Pralatrexate combined with CHOP/COP in newly diagnosed PTCL patients based on Safety for part 2 study. Part 2 (Efficacy and Safety): This is a 3 Arm study. Patients with previously untrea...
What is the current status of trial NCT06072131?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 504 participants. The study started on 2023-10-04. Estimated completion is 2030-11.
What conditions does trial NCT06072131 study?
This clinical trial studies the following conditions: Peripheral T-Cell Lymphoma.
What interventions are being tested in trial NCT06072131?
The interventions under investigation include: CHOP (DRUG), Belinostat Injection (DRUG), Pralatrexate Injection (DRUG), COP (DRUG).
Who is sponsoring clinical trial NCT06072131?
This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06072131 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06072131's enrollment target sits among peer trials
504 2nd of 34 the highest 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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