A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas (NCT07018752) | Clinical Trial Compass
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
France49 participantsStarted 2025-08-20
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓3. 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;
Exclusion criteria
✕. 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;.
What they're measuring
1
Modified Progression-Free Survival
Timeframe: From enrollment to end of follow-up period of Origina-ly-T (= maximum 2 years after enrollment)
2
Maximum Tolerated Dose
Timeframe: From enrollment to end of treatment of sub-study GolcAza (= maximum 2 years from enrollment)
3
Recommended Phase II Dose
Timeframe: From enrollment to end of treatment of sub-study GolcAza (= maximum 2 years from enrollment)
Trial details
NCT IDNCT07018752
SponsorThe Lymphoma Academic Research Organisation
✕. 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;