Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
NCT06072131 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06072131
The ClinicalTrials.gov registry entry for NCT06072131 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 504 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acrotech Biopharma, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06072131 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06072131?
The interventions under investigation include: CHOP (DRUG), Belinostat Injection (DRUG), Pralatrexate Injection (DRUG), COP (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06072131?
This trial is sponsored by Acrotech Biopharma, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.