To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL

Recruiting now · Phase 3

Conditions studied: Peripheral T Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT06072131

Run by

Acrotech Biopharma Inc.

People needed

504

Starts

2023-10-04

Expected to finish

2030-11-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with newly diagnosed, untreated histology-proven PTCL based on local pathology review who is eligible for receiving, Belinostat, Pralatrexate, and CHOP. Pathology material must be available at the site for each patient before enrollment so that it can be sent to the Sponsor (or designee) for later confirmation. The following subtypes, as defined by the updated World Health Organization (WHO) classification, may be included. This information should be available for eligibility:
• Pathology subtype:
• Peripheral T-cell lymphoma, not otherwise specified
• Angioimmunoblastic T-cell lymphoma
• Anaplastic lymphoma kinase (ALK)-negative anaplastic large-cell lymphoma (ALCL) patients are eligible only if Brentuximab Vedotin (BV) is not commercially approved for use, not available in the country or patient is contraindicated to receive BV.
• Follicular T-cell lymphoma
• Others: Extra-nodal natural killer/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; and subcutaneous panniculitis-like T-cell lymphoma
• CD30 expression and T-cell Follicular Helper (TFH) phenotype status must be available for documentation.
• Patient has at least 1 site of measurable disease according to Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria as assessed by the local Investigator (Appendix 3)
• Patient has an Eastern Cooperative Oncology Group performance (ECOG) status ≤2
• For Part 1 (Dose Finding) - Patient has adequate hematological, hepatic, and renal function as defined by:
• 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
• Total bilirubin ≤1.5 mg/dL
• Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3×upper limit of normal (ULN; AST/ALT ≤5×ULN if documented hepatic involvement with lymphoma)
• Calculated creatinine clearance of ≥ 60 mL/min
• Part 2 (Efficacy and Safety) - disease related hypoplasia, hepatological or renal dysfunction can be included if any of the treatment groups can be administered based on package insert recommendation with the following restrictions:
• 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
• Total bilirubin ≤1.5 mg/dL
• Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3 x the upper limit of normal (ULN; AST/ALT ≤5×ULN if documented hepatic involvement with lymphoma)
• Calculated creatinine clearance of ≥ 60 mL/min
• UGT1A1 genotype has been characterized (see Belinostat dose modifications if abnormal) and must be available for documentation.
• Patient must be willing and capable of giving written informed consent and must be able to adhere to dosing and visit schedules and meet all study requirements
• Patient (male or female) is at least 18 years of age at the time of informed consent

You may not qualify if…

• A patient will not be eligible for inclusion if ANY of the criteria listed below apply:
• Patients with a diagnosis of:
• Precursor T-cell lymphoma or leukemia
• Adult T-cell lymphoma/leukemia
• T-cell prolymphocytic leukemia
• T-cell large granular lymphocytic leukemia
• Primary cutaneous type ALCL
• Cutaneous T-cell lymphoma (mycosis fungoides/Sezary syndrome)
• ALCL if they can be treated with Brentuximab Vedotin (BV)
• Patients taking drugs which are potent UGT1A1 inhibitors must discontinue one week before randomization; drug can be resumed if the treatment doesn't include belinostat
• Patient with an active concurrent malignancy/life-threatening disease with the exception of non melanoma skin tumors and in situ cervical cancer if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. If there is a history of prior malignancies/life-threatening diseases, the patient must be disease free for at least 5 years
• Prior histone deacetylase (HDAC) inhibitor or pralatrexate therapy
• Any known cardiac abnormalities such as baseline prolongation of QT/corrected QT (QTc) interval (i.e. demonstration of a QTc interval >450 msec); long QT syndrome; myocardial infarction within 6 months prior to starting study; history of significant cardiovascular disease; the required use of a concomitant medication that may cause Torsades de Pointes
• Patient with uncontrolled hypertension
• Patients status on the following:
• Has a known HIV-positive diagnosis with uncontrolled and detectable viral load
• Has Hepatitis B or Hepatitis C virus diagnosis with uncontrolled and detectable viral load or immunological evidence of chronic active disease
• Patient with central nervous system metastasis
• Patient with an active uncontrolled infection, underlying medical condition, laboratory abnormality, or other serious illness that would impair the ability of the patient to receive protocol treatment
• Patient who has used any investigational drugs, biologics, or devices within 28 days prior to study treatment or plans to use any of these during the course of the study
• Patient with a known history of drug or alcohol abuse
• Pregnant or breastfeeding women

Where it is running

• Ospedale Policlinico San Martino, IRCCS — Genova, Italy (enrolling)
• University of Colorado School of Medicine — Aurora, Colorado, United States (enrolling)
• University of California, San Francisco Fresno — Clovis, California, United States (enrolling)
• Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo — Alessandria, Italy (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
• Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute — Pembroke Pines, Florida, United States (enrolling)
• University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600 — Santa Monica, California, United States (enrolling)
• Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
• Baylor Scott & White Medical Center - Temple — Temple, Texas, United States (enrolling)
• The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
• Princess Margaret Hospital — Toronto, Ontario, Canada (enrolling)
• Universitatsmedizin Gottingen — Göttingen, Germany (enrolling)
• Universitaetsklinikum Halle (Saale) — Halle, Germany (enrolling)
• University of Debrecen Clinical Center — Debrecen, Nagyerdei Krt. 98, Hungary (enrolling)
• Andras Josa University Teaching Hospital — Nyíregyháza, Szent Istvan Utca, Hungary (enrolling)
• Semmelweis Egyetem — Budapest, Hungary (enrolling)
• National Institute of Oncology — Budapest, Hungary (enrolling)
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Belgyogyaszati Klinika es Kardiologiai Kozpont — Szeged, Hungary (enrolling)
• Azienda Ospedaliera Cardinale Giovanni Panico — Tricase, Apulia, Italy (enrolling)
• University of Milano Bicocca — Milan, Bicocca, Italy (enrolling)
• Servizio Sanitario Regionale Emilia-Romagna-Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST) — Meldola, Province Of Forlì-Cesena, Italy (enrolling)
• Policlinico GB Rossi Borgo Roma — Borgo Roma, Verona, Italy (enrolling)
• Azienda Ospedaliera Universitaria di Parma — Parma, Italy (enrolling)

Full record on ClinicalTrials.gov

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