OncoMatch/Clinical Trials/NCT07018752
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Is NCT07018752 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including roginolisib and golcadomide for peripheral t cells lymphoma (ptcl).
Treatment: roginolisib · golcadomide · azacitidine — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received:
Subject in relapse/refractory situation
Cannot have received: standard or experimental anti-cancer drug therapy
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
Cannot have received: corticosteroids
Exception: unless administered at a cumulated dose equivalent of prednisone ≤ 20mg /day (within these 14 days)
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)
Cannot have received: autologous hematopoietic cell transplantation
Exception: auto-HCT ≤ 3 months prior to starting investigational product(s). If subject had autologous SCT > 3 months prior to the start of investigational product(s), any unresolved (Grade > 1) autologous SCT-related toxicity
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
Cannot have received: allogeneic hematopoietic cell transplantation
Exception: allo-HCT ≤ 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 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
Cannot have received: localized anticancer therapy (e.g. radiotherapy)
Subject who has received prior localized anticancer therapy (eg. radiotherapy [including palliative radiotherapy]) ≤ 14 days prior to starting investigational product(s)
Lab requirements
Blood counts
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
Kidney function
calculated CKD-EPI, MDRD or Cockcroft-Gault Creatinine Clearance < 30 ml/min
Liver function
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
Cardiac function
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
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; Impaired renal function (calculated CKD-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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify