OncoMatch/Clinical Trials/NCT06072131
To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
Is NCT06072131 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Belinostat and Pralatrexate for peripheral t cell lymphoma.
Treatment: Belinostat · Pralatrexate · CHOP · COP — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD30 expression status must be available for documentation
CD30 expression ... must be available for documentation
Required: UGT1A1 genotype characterized and must be available for documentation
UGT1A1 genotype has been characterized ... and must be available for documentation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: histone deacetylase (hdac) inhibitor
Cannot have received: pralatrexate (pralatrexate)
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement; Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of bone marrow involvement
Kidney function
Calculated creatinine clearance of ≥ 60 mL/min
Liver function
Total bilirubin ≤1.5 mg/dL; AST/ALT ≤ 3×ULN (≤5×ULN if documented hepatic involvement with lymphoma)
Cardiac function
No known cardiac abnormalities such as baseline prolongation of QT/QTc interval (>450 msec); long QT syndrome; myocardial infarction within 6 months; history of significant cardiovascular disease; required use of a concomitant medication that may cause Torsades de Pointes
adequate hematological, hepatic, and renal function as defined by ... (see criteria); cardiac exclusion criteria listed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco Fresno · Clovis, California
- University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600 · Santa Monica, California
- University of Colorado School of Medicine · Aurora, Colorado
- Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute · Pembroke Pines, Florida
- Norton Cancer Institute · Louisville, Kentucky
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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