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

October 22, 2025 updated by: Acrotech Biopharma Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Design and Treatment Plan:

Part 1: Dose Finding

It is a randomized, open label, multicenter study in patients with PTCL who have not been previously treated and the control arm is CHOP, COP, is the CHOP regimen without Doxorubicin (H). Two investigational agents are separately added to C(H)OP, Belinostat for Bel-CHOP and Pralatrexate for FOL-COP. In this first part, each investigational arm will have two dose levels which will be compared with CHOP as reference. Treatment will be randomized in five arms:

  1. Group 1a (Bel-CHOP) Belinostat 600 mg/m2
  2. Group 1b (Bel-CHOP) Belinostat 1000 mg/m2
  3. Group 2a (Fol-COP) Pralatrexate 20 mg/m2
  4. Group 2b (Fol-COP) Pralatrexate 30 mg/m2
  5. Group 3 for CHOP alone. Analysis will be done when 75 patients have received their planned treatment cycles to evaluate treatment compliance.

Approximately 20 patients will be enrolled into each group and receive at least one cycle of drug thus 15 patients are expected to be evaluated with their planned treatment of 6 cycles completed. The safety data will be evaluated to select the proper dose for Belinostat -CHOP and Pralatrexate-COP for the Part 2 study.

Part 2: Efficacy and Safety

It is a randomized, open-label, multicenter study in newly diagnosed PTCL patients. This is a three arm study and 143 patients will enroll in each arm. Patients will be randomized in a balance manner (1:1:1) into 1 of 3 treatment groups and treated for up to 6 cycles:

Group 1: (Bel-CHOP): Belinostat at the dose determined from Part 1 (600 or 1000 mg/m2) to be administered on Day 1 by 30 min intravenous (IV) infusion once daily for 5 days; CHOP will also be administered starting on Day 1 within 15 min (±5 min) after the end of the belinostat infusion at the doses shown below for Group 3, with cycles repeated every 21 days for up to 6 cycles

Group 2: (Fol-COP): Pralatrexate at the dose determined from part 1 (20 or 30 mg/m2) is to be administered on Day 1 and Day 8 as an IV push over 3 to 5 min; CHOP will also be administered starting on Day 1 within 15 min (±5 min) after the end of the pralatrexate administration at the doses shown below for Group 3, with cycles repeated every 21 days for up to 6 cycles. COP combination refers to CHOP without Doxorubicin (H).

Group 3: (CHOP): Combination chemotherapy to be administered starting on Day 1 at the doses shown below, with cycles repeated every 21 days for up to 6 cycles

  • Cyclophosphamide 750 mg/m2 IV, Day 1
  • Doxorubicin 50 mg/m2 IV, Day 1 (limit lifetime cumulative dose to <550 mg/m² to reduce risk of cardiotoxicity)
  • Vincristine 1.4 mg/m2 (maximum 2 mg) IV, Day 1
  • Prednisone 100 mg orally (PO) daily, Day 1 (after the end of the belinostat or pralatrexate administration for Groups 1 and 2) to Day 5

Randomization will be stratified on:

  • Histology (nodal, extra-nodal)
  • Prognostic Index for T-Cell Lymphoma (Group 1 or 2 vs 3 or 4)
  • Region (US, ex-US)

The study duration will include up to a 28-day screening period, a 6-cycle treatment period (18 weeks), follow-up until progression, an End-of-Treatment Visit at least 30 days after the last dose of study treatment, and long-term survival follow-up for patients by phone every 6 months thereafter until a 5-year median follow-up of the population is reached. Patients discontinuing the study for other reasons than progression will have the same long-term follow-up for OS analysis. Tumor assessments will be performed every 3 cycles (i.e., 9 weeks) on Cycle 4 Day 1 and End-of-Treatment Visit during treatment, then every 3 months for 3 years for patients with complete response (CR), partial response (PR), or stable disease, and every 6 months thereafter until disease progression or death

Study Type

Interventional

Enrollment (Estimated)

504

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital
        • Contact:
        • Principal Investigator:
          • Kevin Imrie, MD
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Princess Margaret Hospital
        • Principal Investigator:
          • Michael Crump, MD
        • Contact:
        • Contact:
  • Germany
      • Göttingen, Germany, 37075
      • Halle, Germany, 06120
  • Hungary
      • Budapest, Hungary, 1088
      • Budapest, Hungary, 1122
        • Recruiting
        • National Institute of Oncology
        • Contact:
        • Principal Investigator:
          • Andras Masszi, MD
      • Eger, Hungary, 3300
        • Recruiting
        • Markhot Ferenc Oktato Korhaz
        • Principal Investigator:
          • Balazs Tajti, MD
      • Szeged, Hungary, 6725
        • Recruiting
        • Belgyogyaszati Klinika es Kardiologiai Kozpont
        • Contact:
        • Contact:
          • Agnes N Lakatos
        • Principal Investigator:
          • Zita Borbenyi, MD
    • Nagyerdei Krt. 98
      • Debrecen, Nagyerdei Krt. 98, Hungary, 4032
        • Recruiting
        • University of Debrecen Clinical Center
        • Contact:
        • Principal Investigator:
          • Illes Arpad, MD
    • Szent Istvan Utca
      • Nyíregyháza, Szent Istvan Utca, Hungary, 68
        • Recruiting
        • Andras Josa University Teaching Hospital
        • Principal Investigator:
          • Laszlo Rejto, MD
        • Contact:
  • Italy
      • Alessandria, Italy
        • Recruiting
        • Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo
        • Principal Investigator:
          • Manuela Zanni, MD
        • Contact:
      • Genova, Italy, 16132
      • Parma, Italy, 43126
        • Recruiting
        • Azienda Ospedaliera Universitaria di Parma
        • Principal Investigator:
          • Caterina Plenteda, MD
        • Contact:
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Principal Investigator:
          • Luca Arcaini, MD
        • Contact:
      • Ravenna, Italy, 41800
        • Recruiting
        • Azienda USL di Ravenna
        • Principal Investigator:
          • Monica Tani, MD
        • Contact:
    • Apulia
      • Tricase, Apulia, Italy, 73039
        • Recruiting
        • Azienda Ospedaliera Cardinale Giovanni Panico
        • Principal Investigator:
          • Vincenzo Pavone, MD
        • Contact:
    • Bicocca
      • Milan, Bicocca, Italy, 20126
        • Recruiting
        • University of Milano Bicocca
        • Principal Investigator:
          • Carlo Gambacorti-Passerini, MD
        • Contact:
    • Province Of Forlì-Cesena
      • Meldola, Province Of Forlì-Cesena, Italy, 47014
        • Recruiting
        • Servizio Sanitario Regionale Emilia-Romagna-Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST)
        • Principal Investigator:
          • Gerardo Musuraca, MD
        • Contact:
        • Contact:
    • Verona
      • Borgo Roma, Verona, Italy, 37134
  • Poland
      • Krakow, Poland, 30-727
      • Warsaw, Poland
        • Recruiting
        • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joanna Romejko-Jarosinska, MD
    • Wroclaw
      • Wroclaw, Wroclaw, Poland, 50-367
        • Recruiting
        • University Hospital in Wroclaw
        • Contact:
          • Bartlomiej Jonca
          • Phone Number: 48-601753371
        • Contact:
        • Principal Investigator:
          • Anna Czyz, MD
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-513
        • Recruiting
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tadeusz Robak, MD
  • South Korea
      • Daegu, South Korea, 42472
        • Recruiting
        • Daegu Catholic University Medical Center
        • Contact:
        • Principal Investigator:
          • Sung Hwa Bae, MD
        • Sub-Investigator:
          • Yun hui Hwang, MD
      • Incheon, South Korea, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Byung Woo Yoon, MD
        • Principal Investigator:
          • Kwai Han Yoo, MD
      • Seoul, South Korea, 6351
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Won-seog Kim, MD
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Youngil Koh, MD
        • Contact:
    • Busanjin District
      • Busan, Busanjin District, South Korea
        • Recruiting
        • Inje university busan paik hospital
        • Contact:
        • Principal Investigator:
          • Won-Sik Lee, MD
    • Dong-gu
      • Ulsan, Dong-gu, South Korea
        • Recruiting
        • Ulsan university hospital
        • Contact:
        • Principal Investigator:
          • Jae-cheol Jo, MD
    • Gyenoggi-do
      • Suwon, Gyenoggi-do, South Korea, 16499
        • Recruiting
        • Ajou University Hospital
        • Contact:
        • Principal Investigator:
          • Seong Hyun Jeong, MD
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, South Korea
        • Recruiting
        • The Catholic University of Korea - St. Vincents Hospital
        • Contact:
          • EunJin Lee, MD
          • Phone Number: 82-31-249-8456
          • Email: i-ej@daum.net
        • Contact:
        • Principal Investigator:
          • Jeong-A Kim, MD
    • Gyeongsangnam-do
      • Jinju, Gyeongsangnam-do, South Korea
        • Recruiting
        • Gyeongsang National University Hospital
        • Contact:
        • Principal Investigator:
          • Gyeong-Won Lee, MD
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, South Korea
        • Recruiting
        • Jeonbuk National University Hospital
        • Contact:
        • Principal Investigator:
          • Jae-Yong Kwak, MD
    • Nam-gu
      • Daegu, Nam-gu, South Korea
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
        • Principal Investigator:
          • Min Kyoung Kim, MD
    • Seoul
      • Sinchon-dong, Seoul, South Korea
        • Recruiting
        • Severance Hospital, Yonsei University
        • Principal Investigator:
          • Jin Seok Kim, MD
        • Contact:
        • Contact:
      • Songpa-dong, Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Dok Hyun Yoon, MD
        • Sub-Investigator:
          • Hyungwoo Cho, MD
        • Sub-Investigator:
          • Jaewon Hyung, MD
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar Medical Research Institute
        • Principal Investigator:
          • Blanca Sánchez González, MD
        • Contact:
        • Contact:
          • Elena Torres Grande
          • Phone Number: 34932483225
      • Barcelona, Spain, 08908
        • Recruiting
        • ICO - Hospital Duran i Reynals
        • Principal Investigator:
          • Eva Domingo Domenech, MD
        • Contact:
        • Contact:
          • Lydia Guillem Micó
          • Phone Number: +34932607750
        • Sub-Investigator:
          • MarÃ-a Belén Ansoleaga à vila, MD
        • Sub-Investigator:
          • Carolina Arevalo, MD
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra - Madrid
        • Principal Investigator:
          • Miguel Angel Albendea Canales, MD
      • Pamplona, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Principal Investigator:
          • Miguel Canales, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Juan Carlos Ponce Jarquin, MD
        • Sub-Investigator:
          • Esteban Tamariz Amador, MD
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario De Salamanca
        • Contact:
          • Dr. Norma Gutierrez, MD
          • Phone Number: 34-923291100
          • Email: normagu@usal.es
        • Principal Investigator:
          • Norma Gutierrez, MD
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politécnico La Fe
        • Contact:
        • Principal Investigator:
          • Rafael Andreu Lapiedra, MD
      • Zaragoza, Spain, 50009
    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48013
    • Madrid
      • Moncloa-Aravaca, Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz
        • Contact:
        • Principal Investigator:
          • Sergio R Cillan, MD
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
        • Contact:
        • Principal Investigator:
          • Jose Maria Arguinano Perez, MD
  • Taiwan
      • Changhua, Taiwan, 505
        • Recruiting
        • Chang Bing Show Chwan Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cheng-Shyong Chang, MD
      • New Taipei City, Taiwan
        • Recruiting
        • Hematology Oncology Taipei Medical University - Shuang-Ho Hospital
        • Contact:
        • Principal Investigator:
          • Tsu Yi Chao, MD
      • Taoyuan District, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital Linkou Branch
        • Contact:
          • Tzi-Chi Liu
          • Phone Number: 886-3-3281200
        • Principal Investigator:
          • Tung-Liang Lin, MD
    • Changhua County
      • Changhua, Changhua County, Taiwan
        • Recruiting
        • Changhua Christian Hospital CCH
        • Contact:
        • Contact:
          • Ya-Tzu Chen
          • Phone Number: +886 4 723 8595
        • Principal Investigator:
          • Hsuan-Yu Lin, MD
    • Hualien
      • Hualien City, Hualien, Taiwan, 970
        • Recruiting
        • Hualien Tzu Chi Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sheng-Chuan Huang, MD
    • Southern Taiwan
      • Tainan City, Southern Taiwan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital Nckuh
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ya-Ting Hsu, MD
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 4522
        • Recruiting
        • Adana City Education and Research Hospital
        • Principal Investigator:
          • Timuçin Çil, MD
        • Contact:
      • Bornova, Turkey (Türkiye), 35100
        • Recruiting
        • Ege Univ. Hospital
        • Contact:
        • Principal Investigator:
          • Guray Saydam, MD
    • Ankara
      • Altındağ, Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Ankara University Medical Faculty Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muhit Ozcan, MD
        • Sub-Investigator:
          • Gul Cebecioglu Hasancebi, MD
        • Sub-Investigator:
          • Hilal Ebru Isikan, MD
      • Yenimahalle, Ankara, Turkey (Türkiye), 06560
        • Recruiting
        • Gazi University Faculty of Medicine
        • Contact:
        • Principal Investigator:
          • Ahmet Ozet, MD
      • Çankaya, Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Bilkent University
        • Contact:
        • Contact:
        • Principal Investigator:
          • OZET GULSUM, MD
        • Sub-Investigator:
          • MEHMET Sezgin Pepeler, MD
    • Istanbul
      • Şişli, Istanbul, Turkey (Türkiye), 34365
        • Recruiting
        • VKV AMERICAN HOSPITAL, Medical Oncology Outpatient Clinic
        • Contact:
        • Principal Investigator:
          • Ahmet b Ferhanoğlu, MD
  • United States
    • California
      • Clovis, California, United States, 93611
      • Santa Monica, California, United States, 90404
        • Recruiting
        • University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600
        • Principal Investigator:
          • Herbert Eradat, MD
        • Contact:
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado School of Medicine
        • Principal Investigator:
          • Bradley Haverkos, MD
        • Contact:
    • Florida
      • Pembroke Pines, Florida, United States, 33026
        • Recruiting
        • Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute
        • Contact:
        • Principal Investigator:
          • Jose Sandoval Sus, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Cancer Institute
        • Principal Investigator:
          • Don Stevens, MD
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:
        • Principal Investigator:
          • JAWAD Z SHEQWARA, MD
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Principal Investigator:
          • Joanna Rhodes, MD
        • Contact:
    • Texas
      • Harlingen, Texas, United States, 78550
        • Withdrawn
        • Valley Cancer Associates
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
        • Contact:
          • Christine Cong
        • Principal Investigator:
          • Ravi Pingali, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas, MD Anderson Cancer Center
        • Principal Investigator:
          • Swaminathan P Iyer, MD
        • Contact:
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White Medical Center - Temple
        • Contact:
        • Principal Investigator:
          • Archana Sagar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1a
Group 1a Belinostat 600 mg/m2 + CHOP
Drug: Belinostat Injection
Belinostat 600 mg/m2 or 1000 mg/m2 along with CHOP is given in each cycle
Other Names:
  • Beleodaq®
Drug: CHOP
CHOP is the comparator arm
Other Names:
  • Cyclophosphamide, Hydroxydaunorubicin (doxorubicin), Oncovin (vincristine), and Prednisone
Active Comparator: Group 1b
Group 1b Belinostat 1000 mg/m2 + CHOP
Drug: Belinostat Injection
Belinostat 600 mg/m2 or 1000 mg/m2 along with CHOP is given in each cycle
Other Names:
  • Beleodaq®
Drug: CHOP
CHOP is the comparator arm
Other Names:
  • Cyclophosphamide, Hydroxydaunorubicin (doxorubicin), Oncovin (vincristine), and Prednisone
Active Comparator: Group 2a
Group 2a Pralatrexate 20 mg/m2 + COP
Drug: Pralatrexate Injection
Pralatrexate 20 mg/m2 or 30 mg/m2 along with COP is given in each cycle
Other Names:
  • Folotyn®
Drug: COP
COP is given in combination with Pralatrexate
Other Names:
  • Cyclophosphamide, Oncovin (vincristine), and Prednisone
Active Comparator: Group 2b
Group 2b Pralatrexate 30 mg/m2 + COP
Drug: Pralatrexate Injection
Pralatrexate 20 mg/m2 or 30 mg/m2 along with COP is given in each cycle
Other Names:
  • Folotyn®
Drug: COP
COP is given in combination with Pralatrexate
Other Names:
  • Cyclophosphamide, Oncovin (vincristine), and Prednisone
Active Comparator: Group 3
CHOP
Drug: CHOP
CHOP is the comparator arm
Other Names:
  • Cyclophosphamide, Hydroxydaunorubicin (doxorubicin), Oncovin (vincristine), and Prednisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 4.5 years
Progression-free survival is determined from randomization to the first documented Progression of Disease or death, whichever occurs first.
4.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 8 years
It is the time from randomization to the death
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acrotech Biopharma Inc.

Investigators

  • Study Director: Uma Srinivas Atmuri, MPharm, MS, Acrotech Biopharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2023

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

October 23, 2025

Last Update Submitted That Met QC Criteria

October 22, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-Bel-301 Study
  • 70,789 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data Review Committee:

An Independent Data Monitoring Committee (IDMC) will be established for the purpose of reviewing patient safety and the results of the futility analysis. The IDMC will convene after the enrollment and analysis of Part 1 to evaluate safety and preliminary efficacy. The IDMC will recommend the selected dose for Belinostat and Pralatrexate. The IDMC will also convene after the analysis of 120 events, in Part 2, to state whether the study can continue.

This Committee will review review study data will adjudicate tumor response and the date of onset of disease progression in all patients at the end of the study. All scans will be centrally reviewed and the primary analysis of PFS will be conducted on these results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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