Actively Recruiting
To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
Led by Acrotech Biopharma Inc. · Updated on 2025-10-23
504
Participants Needed
69
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed, untreated patients with histology-confirmed Peripheral T-Cell Lymphoma (PTCL) eligible for Belinostat, Pralatrexate, and CHOP
- Pathology subtype includes Peripheral T-cell lymphoma not otherwise specified, Angioimmunoblastic T-cell lymphoma, ALK-negative anaplastic large-cell lymphoma if Brentuximab Vedotin is not approved or available, Follicular T-cell lymphoma, and other specified subtypes
- CD30 expression and T-cell Follicular Helper phenotype status documented
- At least one measurable disease site per RECIL 2017 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- For Part 1: Adequate blood counts and liver and kidney function as specified
- For Part 2: Disease-related blood or organ dysfunction allowed if treatment can be given per recommendations
- UGT1A1 genotype characterized and available
- Able and willing to provide informed consent and follow study requirements
- Age 18 years or older at consent
- Willing to use two forms of contraception, including a barrier method, during study and for 6 months after last dose
- Negative pregnancy test within 4 weeks prior to treatment for females of childbearing potential; postmenopausal or surgically sterilized females exempt
You will not qualify if you...
- 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 ALCL, cutaneous T-cell lymphoma, or ALCL treatable with Brentuximab Vedotin
- Use of potent UGT1A1 inhibitors within one week before randomization (unless treatment does not include belinostat)
- Active concurrent malignancy or life-threatening disease except treated non-melanoma skin cancer or in situ cervical cancer disease-free for at least 5 years
- Prior therapy with histone deacetylase inhibitors or pralatrexate
- Known cardiac abnormalities including prolonged QT interval, long QT syndrome, recent myocardial infarction, significant cardiovascular disease, or use of medications causing Torsades de Pointes
- Uncontrolled hypertension
- Known uncontrolled HIV, Hepatitis B or C infection or chronic active disease
- Central nervous system metastasis
- Active uncontrolled infection, serious illness, or laboratory abnormality impairing ability to receive treatment
- Use of investigational drugs, biologics, or devices within 28 days before study treatment
- History of drug or alcohol abuse
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 69 locations
1
University of California, San Francisco Fresno
Clovis, California, United States, 93611
Actively Recruiting
2
University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600
Santa Monica, California, United States, 90404
Actively Recruiting
3
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute
Pembroke Pines, Florida, United States, 33026
Actively Recruiting
5
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Actively Recruiting
6
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
7
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
8
Valley Cancer Associates
Harlingen, Texas, United States, 78550
Withdrawn
9
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
10
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
Baylor Scott & White Medical Center - Temple
Temple, Texas, United States, 76508
Actively Recruiting
12
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
13
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
14
Universitatsmedizin Gottingen
Göttingen, Germany, 37075
Actively Recruiting
15
Universitaetsklinikum Halle (Saale)
Halle, Germany, 06120
Actively Recruiting
16
University of Debrecen Clinical Center
Debrecen, Nagyerdei Krt. 98, Hungary, 4032
Actively Recruiting
17
Andras Josa University Teaching Hospital
Nyíregyháza, Szent Istvan Utca, Hungary, 68
Actively Recruiting
18
Semmelweis Egyetem
Budapest, Hungary, 1088
Actively Recruiting
19
National Institute of Oncology
Budapest, Hungary, 1122
Actively Recruiting
20
Markhot Ferenc Oktato Korhaz
Eger, Hungary, 3300
Actively Recruiting
21
Belgyogyaszati Klinika es Kardiologiai Kozpont
Szeged, Hungary, 6725
Actively Recruiting
22
Azienda Ospedaliera Cardinale Giovanni Panico
Tricase, Apulia, Italy, 73039
Actively Recruiting
23
University of Milano Bicocca
Milan, Bicocca, Italy, 20126
Actively Recruiting
24
Servizio Sanitario Regionale Emilia-Romagna-Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST)
Meldola, Province Of Forlì-Cesena, Italy, 47014
Actively Recruiting
25
Policlinico GB Rossi Borgo Roma
Borgo Roma, Verona, Italy, 37134
Actively Recruiting
26
Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy
Actively Recruiting
27
Ospedale Policlinico San Martino, IRCCS
Genova, Italy, 16132
Actively Recruiting
28
Azienda Ospedaliera Universitaria di Parma
Parma, Italy, 43126
Actively Recruiting
29
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
30
Azienda USL di Ravenna
Ravenna, Italy, 41800
Actively Recruiting
31
University Hospital in Wroclaw
Wroclaw, Wroclaw, Poland, 50-367
Actively Recruiting
32
Pratia MCM Krakow
Krakow, Poland, 30-727
Actively Recruiting
33
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Actively Recruiting
34
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Łódź Voivodeship, Poland, 93-513
Actively Recruiting
35
Inje University Busan Paik Hospital
Busan, Busanjin District, South Korea
Actively Recruiting
36
Ulsan University Hospital
Ulsan, Dong-gu, South Korea
Actively Recruiting
37
Ajou University Hospital
Suwon, Gyenoggi-do, South Korea, 16499
Actively Recruiting
38
The Catholic University of Korea - St. Vincents Hospital
Suwon, Gyeonggi-do, South Korea
Actively Recruiting
39
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Actively Recruiting
40
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Actively Recruiting
41
Yeungnam University Medical Center
Daegu, Nam-gu, South Korea
Actively Recruiting
42
Severance hospital, Yonsei University
Sinchon-dong, Seoul, South Korea
Actively Recruiting
43
Asan Medical Center
Songpa-dong, Seoul, South Korea, 05505
Actively Recruiting
44
Daegu Catholic University Medical Center
Daegu, South Korea, 42472
Actively Recruiting
45
Gachon University Gil Medical Center
Incheon, South Korea, 21565
Actively Recruiting
46
Samsung Medical Center
Seoul, South Korea, 6351
Actively Recruiting
47
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
48
Hospital Universitario Basurto
Bilbao, Bizkaia, Spain, 48013
Actively Recruiting
49
Hospital Universitario Fundación Jiménez Díaz
Moncloa-Aravaca, Madrid, Spain, 28040
Actively Recruiting
50
Hospital Universitario de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
51
Hospital del Mar Medical Research Institute
Barcelona, Spain, 08003
Actively Recruiting
52
ICO - Hospital Duran i Reynals
Barcelona, Spain, 08908
Actively Recruiting
53
Clinica Universidad de Navarra - Madrid
Madrid, Spain, 28027
Actively Recruiting
54
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
55
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
56
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
57
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
58
Changhua Christian Hospital CCH
Changhua, Changhua County, Taiwan
Actively Recruiting
59
Hualien Tzu Chi Medical Center
Hualien City, Hualien, Taiwan, 970
Actively Recruiting
60
National Cheng Kung University Hospital NCKUH
Tainan, Southern Taiwan, Taiwan, 704
Actively Recruiting
61
Chang Bing Show Chwan Memorial Hospital
Changhua, Taiwan, 505
Actively Recruiting
62
Hematology Oncology Taipei Medical University - Shuang-Ho Hospital
New Taipei City, Taiwan
Actively Recruiting
63
Chang Gung Memorial Hospital Linkou Branch
Taoyuan, Taiwan, 333
Actively Recruiting
64
Ankara University Medical Faculty Hospital
Altındağ, Ankara, Turkey (Türkiye), 06230
Actively Recruiting
65
Bilkent University
Çankaya, Ankara, Turkey (Türkiye), 06800
Actively Recruiting
66
Gazi University Faculty of Medicine
Yenimahalle, Ankara, Turkey (Türkiye), 06560
Actively Recruiting
67
VKV AMERICAN HOSPITAL, Medical Oncology Outpatient Clinic
Şişli, Istanbul, Turkey (Türkiye), 34365
Actively Recruiting
68
Adana City Education and Research Hospital
Adana, Turkey (Türkiye), 4522
Actively Recruiting
69
Ege Univ. Hospital
Bornova, Turkey (Türkiye), 35100
Actively Recruiting
Research Team
U
Uma Srinivas Atmuri, MPharm, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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