Condition: Peripheral T Cell Lymphoma · Sponsor: Acrotech Biopharma Inc.
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.
This description comes directly from the study's public registry record.
Uma Srinivas Atmuri, MPharm, MS · 732-917-2420 · uatmuri@acrotechbiopharma.com
Always discuss trial participation with your own doctor first.
| University of California, San Francisco Fresno | Clovis, California, United States | Recruiting |
| University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600 | Santa Monica, California, United States | Recruiting |
| University of Colorado School of Medicine | Aurora, Colorado, United States | Recruiting |
| Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute | Pembroke Pines, Florida, United States | Recruiting |
| Norton Cancer Institute | Louisville, Kentucky, United States | Recruiting |
| Henry Ford Health System | Detroit, Michigan, United States | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick, New Jersey, United States | Recruiting |
| Valley Cancer Associates | Harlingen, Texas, United States | Withdrawn |
| Houston Methodist Hospital | Houston, Texas, United States | Withdrawn |
| University of Texas, MD Anderson Cancer Center | Houston, Texas, United States | Recruiting |
| Baylor Scott & White Medical Center - Temple | Temple, Texas, United States | Recruiting |
| The Ottawa Hospital | Ottawa, Ontario, Canada | Recruiting |
+ 57 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06072131