A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma

Status: Recruiting
Location: See all (67) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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.

⁃ 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.

Locations
United States
California
University of California, San Francisco Fresno
RECRUITING
Clovis
University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600
RECRUITING
Santa Monica
Colorado
University of Colorado School of Medicine
RECRUITING
Aurora
Florida
Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute
RECRUITING
Pembroke Pines
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
Michigan
Henry Ford Health System
RECRUITING
Detroit
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Texas
Valley Cancer Associates
WITHDRAWN
Harlingen
Houston Methodist Hospital
RECRUITING
Houston
University of Texas, MD Anderson Cancer Center
RECRUITING
Houston
Baylor Scott & White Medical Center - Temple
RECRUITING
Temple
Other Locations
Canada
The Ottawa Hospital
RECRUITING
Ottawa
Princess Margaret Hospital
RECRUITING
Toronto
Germany
Universitatsmedizin Gottingen
RECRUITING
Göttingen
Universitaetsklinikum Halle (Saale)
RECRUITING
Halle
Hungary
National Institute of Oncology
RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
University of Debrecen Clinical Center
RECRUITING
Debrecen
Markhot Ferenc Oktato Korhaz
RECRUITING
Eger
Andras Josa University Teaching Hospital
RECRUITING
Nyíregyháza
Belgyogyaszati Klinika es Kardiologiai Kozpont
RECRUITING
Szeged
Italy
Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo
RECRUITING
Alessandria
Policlinico GB Rossi Borgo Roma
RECRUITING
Borgo Roma
Ospedale Policlinico San Martino, IRCCS
RECRUITING
Genova
Servizio Sanitario Regionale Emilia-Romagna-Istituto Scientifico Romagnolo per lo Studio dei Tumori Dino Amadori Srl (IRST)
RECRUITING
Meldola
University of Milano Bicocca
RECRUITING
Milan
Azienda Ospedaliera Universitaria di Parma
RECRUITING
Parma
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Azienda USL di Ravenna
RECRUITING
Ravenna
Azienda Ospedaliera Cardinale Giovanni Panico
RECRUITING
Tricase
Poland
Pratia MCM Krakow
RECRUITING
Krakow
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
RECRUITING
Warsaw
Republic of Korea
Inje University Busan Paik Hospital
RECRUITING
Busan
Daegu Catholic University Medical Center
RECRUITING
Daegu
Yeungnam University Medical Center
RECRUITING
Daegu
Gachon University Gil Medical Center
RECRUITING
Incheon
Jeonbuk National University Hospital
RECRUITING
Jeonju
Gyeongsang National University Hospital
RECRUITING
Jinju
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance hospital, Yonsei University
RECRUITING
Sinchon-dong
Asan Medical Center
RECRUITING
Songpa-dong
Ajou University Hospital
RECRUITING
Suwon
The Catholic University of Korea - St. Vincents Hospital
RECRUITING
Suwon
Ulsan University Hospital
RECRUITING
Ulsan
Spain
Hospital del Mar Medical Research Institute
RECRUITING
Barcelona
ICO - Hospital Duran i Reynals
RECRUITING
Barcelona
Hospital Universitario Basurto
RECRUITING
Bilbao
Clinica Universidad de Navarra - Madrid
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Moncloa-aravaca
Clinica Universidad de Navarra
RECRUITING
Pamplona
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario y Politecnico La Fe
RECRUITING
Valencia
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Taiwan
Chang Bing Show Chwan Memorial Hospital
RECRUITING
Changhua
Changhua Christian Hospital CCH
RECRUITING
Changhua
Hualien Tzu Chi Medical Center
RECRUITING
Hualien City
Hematology Oncology Taipei Medical University - Shuang-Ho Hospital
RECRUITING
New Taipei City
National Cheng Kung University Hospital NCKUH
RECRUITING
Tainan City
Chang Gung Memorial Hospital Linkou Branch
RECRUITING
Taoyuan District
Turkey
Adana City Education and Research Hospital
RECRUITING
Adana
Ankara University Medical Faculty Hospital
RECRUITING
Altındağ
Ege Univ. Hospital
RECRUITING
Bornova
Bilkent University
RECRUITING
Çankaya
VKV AMERICAN HOSPITAL, Medical Oncology Outpatient Clinic
RECRUITING
Şişli
Gazi University Faculty of Medicine
RECRUITING
Yenimahalle
Contact Information
Primary
Uma Srinivas Atmuri, MPharm, MS
uatmuri@acrotechbiopharma.com
732-917-2420
Time Frame
Start Date: 2023-10-04
Estimated Completion Date: 2030-11
Participants
Target number of participants: 504
Treatments
Active_comparator: Group 1a
Group 1a Belinostat 600 mg/m2 + CHOP
Active_comparator: Group 1b
Group 1b Belinostat 1000 mg/m2 + CHOP
Active_comparator: Group 2a
Group 2a Pralatrexate 20 mg/m2 + COP
Active_comparator: Group 2b
Group 2b Pralatrexate 30 mg/m2 + COP
Active_comparator: Group 3
CHOP
Sponsors
Leads: Acrotech Biopharma Inc.

This content was sourced from clinicaltrials.gov