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

Recruiting now · Phase 1/Phase 2

Conditions studied: Peripheral T Cells Lymphoma (PTCL)

In brief

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

Key facts

Study ID

NCT07018752

Run by

The Lymphoma Academic Research Organisation

People needed

49

Starts

2025-08-20

Expected to finish

2030-01-01

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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);
• Active malignancy other than the one treated in this research, unless the subject has been free of the disease for 2 years (subjects with a history of a completely resected non-melanoma skin cancer or successfully treated for an in-situ carcinoma are eligible);
• Use of any standard or experimental anti-cancer drug therapy within 28 days or a minimum of 5 half-lives of the drug, whatever the shortest prior to first administration of study drug;.
• Subject taking corticosteroids within 14 days prior to first administration of study drug, unless administered at a cumulated dose equivalent of prednisone ≤ 20mg /day (within these 14 days);
• Subject with prior autologous hematopoietic cell transplantation (auto-HCT) ≤ 3 months prior to starting investigational product(s). If subject had autologous SCT (Stem Cell Transplant) > 3 months prior to the start of investigational product(s), any unresolved (Grade > 1) autologous SCT-related toxicity;
• Subject with prior allogeneic hematopoietic cell transplantation (allo-HCT) with either standard or reduced intensity conditioning ≤ 3 months prior to starting investigational product(s). If subject had allogeneic SCT > 3 months prior to the start of investigational product(s) and still has any unresolved situation including (Grade > 1) treatment-related toxicity and/or ongoing immunosuppressor therapy and/or more than mild (NIH consensus) chronic graft-versus-host disease;
• Subject with major surgery ≤ 14 days prior to starting investigational product(s). Subjects must have recovered from any clinically significant effects of recent surgery;
• Subject who has received prior localized anticancer therapy (eg. radiotherapy [including palliative radiotherapy]) ≤ 14 days prior to starting investigational product(s);
• Known or suspected hypersensitivity to active substance or to any of the excipients;
• Pregnant, planning to become pregnant, or lactating woman;
• Person deprived of his/her liberty by a judicial or administrative decision;
• Exclusion criteria specific to Origina-ly-T sub-study:
• Positive HIV test at screening, with the following exception: individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to HIV within the last 12 months
• Impaired renal function (calculated CKP-EPI, MDRD or Cockcroft-Gault Creatinine Clearance < 30 ml/min) or impaired liver function tests (serum total bilirubin level > 34 μmol/L), except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma, serum transaminases (AST or ALT) > 3 upper normal limits, unless elevated to up to 5 x ULN due to peripheral T-cells lymphoma);
• Significant cardiovascular disease [e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure \| American Heart Association)], myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina);
• Prior exposure to PI3Kdelta inhibitor;
• Known or suspected allergies, hypersensitivity, or intolerance to Roginolisib or its excipients;
• Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications;
• Subjects with a diagnosis of cutaneous T-cell lymphoma (CTCL);
• Prior solid organ transplantation;
• Exclusion criteria specific to GolcAza sub-study:
• Evidence of positive HTLV1 serology;

Where it is running

• Institut d'Hématologie de Basse Normandie - Service Hématologie (CHU Hôpital Côte de Nacre) — Caen, France (enrolling)
• Hôpital Necker - Service Hématologie Adultes — Paris, France (enrolling)
• CHU Lyon-Sud - Hématologie Clinique — Pierre-Bénite, France (enrolling)
• CHU de Poitiers - Hôpital de la Milétrie - Service d'Oncologie Hématologique et Thérapie Cellulaire — Poitiers, France (enrolling)
• Centre Henri Becquerel - Service Hématologie — Rouen, France (enrolling)
• Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie — Saint-Etienne, France (enrolling)
• CH de la Côte Basque - Service Hématologie — Saint-Jean-de-Luz, France (enrolling)
• Institut de Cancérologie Strasbourg Europe - Service Hématologie — Strasbourg, France (enrolling)
• Hôpital Henri Mondor - Unité Hémopathies Lymphoïdes — Créteil, France (enrolling)
• CHU Dijon Bourgogne - Service Hématologie Clinique — Dijon, France (enrolling)
• CHU de Lille - Hôpital Claude Huriez - Service des Maladies du Sang — Lille, France (enrolling)
• CHU de Montpellier - Département d'Hématologie Clinique — Montpellier, France (enrolling)
• CHU de Nantes - Service Hématologie — Nantes, France (enrolling)
• CHU Estaing - Service Thérapie Cellulaire et Hématologie Clinique — Clermont-Ferrand, France
• CHU de Bordeaux - Hôpital Haut-Lévêque - Centre François Magendie - Service d'Hématologie et Thérapie Cellulaire — Pessac, France
• CHU Pontchaillou - Hématologie Clinique — Rennes, France
• CHU de Grenoble - Service Hématologie — La Tronche, France
• CH du Mans - Centre de Cancérologie de la Sarthe - Service Hématologie — Le Mans, France
• CHRU Nancy - Hôpital Brabois - Service Hématologie — Vandœuvre-lès-Nancy, France
• Institut Paoli Calmettes - Service Hématologie — Marseille, France

Full record on ClinicalTrials.gov

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