To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
NCT ID: NCT06072131
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
504 participants
INTERVENTIONAL
2023-10-04
2030-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)
NCT02594267
Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients
NCT01420679
Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)
NCT01839097
Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma
NCT06561048
To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan
NCT02162771
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1a
Group 1a Belinostat 600 mg/m2 + CHOP
Belinostat Injection
Belinostat 600 mg/m2 or 1000 mg/m2 along with CHOP is given in each cycle
CHOP
CHOP is the comparator arm
Group 1b
Group 1b Belinostat 1000 mg/m2 + CHOP
Belinostat Injection
Belinostat 600 mg/m2 or 1000 mg/m2 along with CHOP is given in each cycle
CHOP
CHOP is the comparator arm
Group 2a
Group 2a Pralatrexate 20 mg/m2 + COP
Pralatrexate Injection
Pralatrexate 20 mg/m2 or 30 mg/m2 along with COP is given in each cycle
COP
COP is given in combination with Pralatrexate
Group 2b
Group 2b Pralatrexate 30 mg/m2 + COP
Pralatrexate Injection
Pralatrexate 20 mg/m2 or 30 mg/m2 along with COP is given in each cycle
COP
COP is given in combination with Pralatrexate
Group 3
CHOP
CHOP
CHOP is the comparator arm
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Acrotech Biopharma Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Uma Srinivas Atmuri, MPharm, MS
Role: STUDY_DIRECTOR
Acrotech Biopharma Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Francisco Fresno
Clovis, California, United States
University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600
Santa Monica, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute
Pembroke Pines, Florida, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Henry Ford Health System
Detroit, Michigan, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Valley Cancer Associates
Harlingen, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, United States
The Ottawa Hospital
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Universitatsmedizin Gottingen
Göttingen, , Germany
Universitaetsklinikum Halle (Saale)
Halle, , Germany
University of Debrecen Clinical Center
Debrecen, Nagyerdei Krt. 98, Hungary
Andras Josa University Teaching Hospital
Nyíregyháza, Szent Istvan Utca, Hungary
Semmelweis Egyetem
Budapest, , Hungary
National Institute of Oncology
Budapest, , Hungary
Markhot Ferenc Oktato Korhaz
Eger, , Hungary
Belgyogyaszati Klinika es Kardiologiai Kozpont
Szeged, , Hungary
Azienda Ospedaliera Cardinale Giovanni Panico
Tricase, Apulia, Italy
University of Milano Bicocca
Milan, Bicocca, Italy
Servizio Sanitario Regionale Emilia-Romagna-Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST)
Meldola, Province Of Forlì-Cesena, Italy
Policlinico GB Rossi Borgo Roma
Borgo Roma, Verona, Italy
Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo
Alessandria, , Italy
Ospedale Policlinico San Martino, IRCCS
Genova, , Italy
Azienda Ospedaliera Universitaria di Parma
Parma, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Azienda USL di Ravenna
Ravenna, , Italy
University Hospital in Wroclaw
Wroclaw, Wroclaw, Poland
Pratia MCM Krakow
Krakow, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Łódź Voivodeship, Poland
Inje University Busan Paik Hospital
Busan, Busanjin District, South Korea
Ulsan University Hospital
Ulsan, Dong-gu, South Korea
Ajou University Hospital
Suwon, Gyenoggi-do, South Korea
The Catholic University of Korea - St. Vincents Hospital
Suwon, Gyeonggi-do, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Yeungnam University Medical Center
Daegu, Nam-gu, South Korea
Severance hospital, Yonsei University
Sinchon-dong, Seoul, South Korea
Asan Medical Center
Songpa-dong, Seoul, South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hospital Universitario Basurto
Bilbao, Bizkaia, Spain
Hospital Universitario Fundación Jiménez Díaz
Moncloa-Aravaca, Madrid, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Hospital del Mar Medical Research Institute
Barcelona, , Spain
ICO - Hospital Duran i Reynals
Barcelona, , Spain
Clinica Universidad de Navarra - Madrid
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Changhua Christian Hospital CCH
Changhua, Changhua County, Taiwan
Hualien Tzu Chi Medical Center
Hualien City, Hualien, Taiwan
National Cheng Kung University Hospital NCKUH
Tainan City, Southern Taiwan, Taiwan
Chang Bing Show Chwan Memorial Hospital
Changhua, , Taiwan
Hematology Oncology Taipei Medical University - Shuang-Ho Hospital
New Taipei City, , Taiwan
Chang Gung Memorial Hospital Linkou Branch
Taoyuan District, , Taiwan
Ankara University Medical Faculty Hospital
Altındağ, Ankara, Turkey (Türkiye)
Bilkent University
Çankaya, Ankara, Turkey (Türkiye)
Gazi University Faculty of Medicine
Yenimahalle, Ankara, Turkey (Türkiye)
VKV AMERICAN HOSPITAL, Medical Oncology Outpatient Clinic
Şişli, Istanbul, Turkey (Türkiye)
Adana City Education and Research Hospital
Adana, , Turkey (Türkiye)
Ege Univ. Hospital
Bornova, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Christine Cong
Role: backup
Agnes N Lakatos
Role: backup
Bartlomiej Jonca
Role: primary
Elena Torres Grande
Role: backup
Lydia Guillem Micó
Role: backup
Ya-Tzu Chen
Role: backup
Tzi-Chi Liu
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
70,789
Identifier Type: OTHER
Identifier Source: secondary_id
SPI-Bel-301 Study
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.