This study is a platform trial for the evaluation of new drugs or combination of drugs in relapsed or refractory peripheral T-cell lymphomas.
The objective of the study is to generate exploratory data on new drugs or combination of drugs to treat refractory/relapse peripheral T-cells lymphoma to better identify the population of interest and design future correct clinical trials.
Primary objectives of the different sub-studies :
* phase 1 sub-studies: determine the safety and tolerability of escalating doses of the sub-study treatment * phase 2 sub-studies: identify drugs that will improve significantly the outcome in target patients Secondary objectives of both sub-studies: analyze the response rate, the clinical benefit rate, the progression-free survival, the duration of response, the time to next treatment or death, the overall survival, the rate of transplantation following study treatment and the safety profile of the drugs used
Subject who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted;
Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF);
Subject is willing and able to adhere to the study visit schedule and other protocol requirements;
Subject with histologically proven peripheral T-cell lymphoma according to the criteria of the WHO classification 2017 or 2022 (subjects with mycosis fungoides, Sezary syndrome, lymphoblastic or large granular lymphocytic lymphoma will be excluded). Tumor tissue (initial diagnosis or relapse) should be available for central pathology review and biological characterization;
Evidence of central nervous system involvement by lymphoma;
Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision);
Uncontrolled systemic fungal, bacterial, or viral infection;
Known Hepatitis C Virus (HCV) or active Hepatitis B Virus (HBV) infection defined as subject with detectable viral load (respectively detectable viral RNA or detectable viral DNA);
The Lymphoma Academic Research Organisation
Lead sponsor
iOnctura
Collaborator
AbbVie
Collaborator
Bristol-Myers Squibb
Collaborator