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Clinical Trials in Germany / NCT06072131
Recruiting Phase 3

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

NCT06072131 · tracked via the Priya Life Science Germany tracker
Sponsor
Acrotech Biopharma Inc
Phase
Phase 3
Started
2023-10-04
Last updated
2026-07-22

Condition(s) studied

Peripheral T Cell Lymphoma

Investigational drug(s) / intervention(s)

Belinostat Injection →Pralatrexate Injection →CHOP →COP →

Belinostat Injection: Belinostat 600 mg/m2 or 1000 mg/m2 along with CHOP is given in each cycle

Pralatrexate Injection: Pralatrexate 20 mg/m2 or 30 mg/m2 along with COP is given in each cycle

CHOP: CHOP is the comparator arm

COP: COP is given in combination with Pralatrexate

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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: 1. 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 2. CD30 expression and T-cell Follicular Helper (TFH) phenotype status must be available for documentation. 2. 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) 3. Patient has an Eastern Cooperative Oncology Group performance (ECOG) status ≤2 4. For Part 1 (Dose Finding) - Patient has adequate hematological, hepatic, and renal function as defined by: 1. Absolute neutrophil count ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement 2. Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of bone marrow involvement 3. Total bilirubin ≤1.5 mg/dL 4. 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) 5. Calculated creatinine clearance of ≥ 60 mL/min 5. 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: 1. Absolute neutrophil count ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement 2. Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of bone marrow involvement 3. Total bilirubin ≤1.5 mg/dL 4. 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) 5. Calculated creatinine clearance of ≥ 60 mL/min 6. UGT1A1 genotype has been characterized (see Belinostat dose modifications if abnormal) and must be available for documentation. 7. 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 8. Patient (male or female) is at least 18 years of age at the time of informed consent 9. Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 6 months after the last dose of study treatment. 10. Females of childbearing potential must have a negative urine pregnancy test within 4 weeks prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test. Exclusion Criteria: A patient will not be eligible for inclusion if ANY of the criteria listed below apply: 1. Patients with a diagnosis of: 1. Precursor T-cell lymphoma or leukemia 2. Adult T-cell lymphoma/leukemia 3. T-cell prolymphocytic leukemia 4. T-cell large granular lymphocytic leukemia 5. Primary cutaneous type ALCL 6. Cutaneous T-cell lymphoma (mycosis fungoides/Sezary syndrome) 7. ALCL if they can be treated with Brentuximab Vedotin (BV) 2. 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 3. 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 4. Prior histone deacetylase (HDAC) inhibitor or pralatrexate therapy 5. 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 6. Patient with uncontrolled hypertension 7. Patients status on the following: 1. Has a known HIV-positive diagnosis with uncontrolled and detectable viral load 2. Has Hepatitis B or Hepatitis C virus diagnosis with uncontrolled and detectable viral load or immunological evidence of chronic active disease 8. Patient with central nervous system metastasis 9. 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 10. 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 11. Patient with a known history of drug or alcohol abuse 12. Pregnant or breastfeeding women

Primary outcome measure(s)

Trial sites (69)

FacilityCityRegionStatus
University of California, San Francisco Fresno Clovis California Recruiting
University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600 Santa Monica California Recruiting
University of Colorado School of Medicine Aurora Colorado Recruiting
Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute Pembroke Pines Florida Recruiting
Norton Cancer Institute Louisville Kentucky Recruiting
Henry Ford Health System Detroit Michigan Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey Recruiting
Valley Cancer Associates Harlingen Texas Withdrawn
Houston Methodist Hospital Houston Texas Withdrawn
University of Texas, MD Anderson Cancer Center Houston Texas Recruiting
Baylor Scott & White Medical Center - Temple Temple Texas Recruiting
The Ottawa Hospital Ottawa Ontario Recruiting
Princess Margaret Hospital Toronto Ontario Recruiting
Universitatsmedizin Gottingen Göttingen Germany Recruiting
Universitaetsklinikum Halle (Saale) Halle Germany Recruiting
University of Debrecen Clinical Center Debrecen Nagyerdei Krt. 98 Recruiting
Andras Josa University Teaching Hospital Nyíregyháza Szent Istvan Utca Recruiting
Semmelweis Egyetem Budapest Hungary Recruiting
National Institute of Oncology Budapest Hungary Recruiting
Markhot Ferenc Oktato Korhaz Eger Hungary Withdrawn
Belgyogyaszati Klinika es Kardiologiai Kozpont Szeged Hungary Recruiting
Azienda Ospedaliera Cardinale Giovanni Panico Tricase Apulia Recruiting
University of Milano Bicocca Milan Bicocca Recruiting
Servizio Sanitario Regionale Emilia-Romagna-Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST) Meldola Province Of Forlì-Cesena Recruiting
Policlinico GB Rossi Borgo Roma Borgo Roma Verona Recruiting
Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo Alessandria Italy Recruiting
Ospedale Policlinico San Martino, IRCCS Genova Italy Recruiting
Azienda Ospedaliera Universitaria di Parma Parma Italy Recruiting
Fondazione IRCCS Policlinico San Matteo Pavia Italy Recruiting
Azienda USL di Ravenna Ravenna Italy Recruiting
University Hospital in Wroclaw Wroclaw Wroclaw Recruiting
Pratia MCM Krakow Krakow Poland Recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Warsaw Poland Recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lodz Łódź Voivodeship Recruiting
Inje University Busan Paik Hospital Busan Busanjin District Recruiting
Ulsan University Hospital Ulsan Dong-gu Withdrawn
Ajou University Hospital Suwon Gyenoggi-do Recruiting
The Catholic University of Korea - St. Vincents Hospital Suwon Gyeonggi-do Recruiting
Gyeongsang National University Hospital Jinju Gyeongsangnam-do Withdrawn
Jeonbuk National University Hospital Jeonju Jeollabuk-do Withdrawn

+ 29 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06072131 on ClinicalTrials.gov ↗ ← All trials in Germany