A Phase 3 study to evaluate safety and efficacy of the combination of for Bel- CHOP/ Fol-COP drugs against CHOP in newly diagnosed Peripheral T-Cell Lymphoma (blood cancer) patients
- Conditions
- Peripheral T-Cell LymphomaMedDRA version: 21.1Level: PTClassification code: 10034623Term: Peripheral T-cell lymphoma unspecified Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507803-76-00
- Lead Sponsor
- Acrotech Biopharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 499
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 WHO classification, may be included. This information should be available for eligibility: a. Pathology subtype: o Peripheral T-cell lymphoma, not otherwise specified o Angioimmunoblastic T-cell lymphoma o Anaplastic lymphoma kinase (ALK)- negative anaplastic large-cell lymphoma (ALCL) o Follicular T cell lymphoma o 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 b.CD30 expression c. TFH phenotype 2. Patient has at least 1 site of measurable disease according to Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria as assessed by local Investigator. 3. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status = 2. 4. For Part 1 (Dose Finding) - Patient has adequate hematological, hepatic, and renal function as defined in the protocol. 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 restrictions defined in the protocol. 6. UGT1A1 genotype has been characterized (see Belinostat dose modifications if abnormal). 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 time of 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 30 days 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.
1. Patients with a diagnosis of: a. Precursor T-cell lymphoma or leukemia b. Adult T-cell lymphoma/leukemia c. T-cell prolymphocytic leukemia d. T-cell large granular lymphocytic leukemia e. Primary cutaneous type ALCL h. Cutaneous T-cell lymphoma (mycosis fungoides/Sezary syndrome) i. ALCL except if Brentuximab Vendotin cannot be utilized 2. Patients taking drugs which are potent UGT1A1 inhibitors must discontinue one week before dosing 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 incomplete 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 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: a) Has a known HIV-positive diagnosis with uncontrolled and detectable viral load b) 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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method