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A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllThe Lymphoma Academic Research Organisation
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
1. Subject who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted; 2. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF); 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements; 4. 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; 5. Subject in relapse/refractory situation; 6. ECOG performance status 0 to 2, or 3 if thought to be related to lymphoma; 7. Adequate bone marrow function as defined by: * Absolute Neutrophil Count ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if related to lymphoma) * Platelets ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if related to lymphoma) * Hemoglobin ≥ 8 g/dL; 8. Anticipated life expectancy at least 3 months; 9. Presence of disease specific criteria allowing response evaluation. Unless otherwise specified, such criteria include: 1. Baseline fluorodeoxyglucose PET-scan demonstrating at least one positive (FDG-avid) lesion; 2. and at least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extra nodal lesion, defined as \> 1.0 cm in its longest dimension; 10. Contraception: * For women of childbearing potential (WOCBP): must have a negative result for pregnancy test, at screening and within 24 hours prior to initiating study treatment. The WOCBP agree to abstain from becoming pregnant or breastfeeding, to remain abstinent (from heterosexual intercourse) or use at least one highly effective method of contraception and to refrain from donating eggs, during the treatment period (including periods of treatment interruption) and for at least the delay described in the sub-protocol for the concerned molecules; * For men of reproductive potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use at least a condom as method of contraception with a non-pregnant female partner of childbearing potential or a pregnant female partner, and to refrain from donating sperm, during the treatment period (including periods of treatment interruption), and for at least the delay described in the sub-protocol for the concerned molecules; 11. Subject covered by a social security system; 12. Subject who understands and speaks one of the country official languages unless local regulation authorizes independent translators; Additional inclusion criteria specific to Origina-ly-T sub-study: 13. For anaplastic large cell lymphoma subjects: failed or ineligible or intolerant to brentuximab vedotin. For extranodal NK/T-cells lymphoma: failed or ineligible or intolerant to asparaginase-containing regimen; Additional inclusion criteria specific to Golcaza sub-study: 13\. Subject had local diagnosed (nodal) follicular helper T cell lymphoma according to WHO classification 2022 or ICC 2022 classification based on a surgical lymph node biopsy or needle core biopsy including any one of the following type: * angioimmunoblastic type (AITL) * follicular T cell type * not otherwise specified (NOS); 14\. ECOG performance status 0 to 1 (supersedes criterium 6 of the Master protocol); 15\. Subjects must have an international normalized ratio (INR) \< 1.5 x ULN and partial thromboplastin time (aPTT) \< 1.5 x ULN (for subjects not receiving therapy). Note: Subjects receiving therapy for a thromboembolic event that occurred \> 3months prior to enrollment are eligible as long as they are on a stable regimen of anticoagulation with warfarin, low-molecular weight heparin, or other approved therapeutic anticoagulation or antiplatelet regimen; 16\. Contraception (supersedes criterium 10 of the Master protocol): * For women of childbearing potential (WOCBP): must have a negative result for pregnancy test, 10 to 14 days prior to initiating study treatment and within 24 hours prior to initiating study treatment. WOCBP agree to abstain from becoming pregnant or breastfeeding and to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one highly effective method of contraception , at least 28 days before the first dose of study treatment , during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide, and 6 months after the last dose of azacitidine. Women must refrain from donating eggs during this same period; * For men: during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide and 3 months after the last dose of oral 5-azacitidine male subjects must: * With female partners of childbearing potential: use a condom associated with a highly effective method of contraception or remain abstinent (refrain from heterosexual intercourse) * With pregnant female partners: use a condom or remain abstinent (refrain from heterosexual intercourse) Men must refrain from donating sperm during this same period; Exclusion Criteria: 1. Evidence of central nervous system involvement by lymphoma; 2. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision); 3. Uncontrolled systemic fungal, bacterial, or viral infection; 4. 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); 5. Active malignancy other than the one treated in this research, unless the s
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What it tests

  • roginolisib
  • golcadomide
  • azacitidine
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Where

20 sites
Institut d'Hématologie de Basse Normandie - Service Hématologie (CHU Hôpital Côte de Nacre)
Caen, France
CHU Estaing - Service Thérapie Cellulaire et Hématologie Clinique
Clermont-Ferrand, France
Hôpital Henri Mondor - Unité Hémopathies Lymphoïdes
Créteil, France
CHU Dijon Bourgogne - Service Hématologie Clinique
Dijon, France
CHU de Grenoble - Service Hématologie
La Tronche, France
CH du Mans - Centre de Cancérologie de la Sarthe - Service Hématologie
Le Mans, France
CHU de Lille - Hôpital Claude Huriez - Service des Maladies du Sang
Lille, France
Institut Paoli Calmettes - Service Hématologie
Marseille, France

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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