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

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT07018752
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Peripheral T Cells Lymphoma (PTCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • roginolisib — DRUG
    Roginolisib daily intake
  • golcadomide — DRUG
    Golcadomide daily intake
  • azacitidine — DRUG
    oral 5-azacitidine daily intake

Study Details

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 Dates

First listed
Jun 12, 2025
Start date
Aug 20, 2025
Status verified
Jun 2025
Primary completion
Apr 30, 2028
Completion
Jan 31, 2030

Study Design

Enrollment
49 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Origina-ly-T
    Open-label phase 2 sub-study to evaluate the efficacy and safety of roginolisib in relapsed/refractory peripheral T-cells lymphoma. Study treatment will be administered until unacceptable toxicity, disease progression, subject/physician decision to withdraw, whichever happens first. 31 evaluable patients needed.
  • Experimental: GolcAza
    Open-label phase 1 sub-study to identify the maximum tolerated dose of golcadomide in association with oral 5-azacitidine and evaluate the efficacy and safety of the determined combination of oral 5-azacitidine and golcadomide in relapsed/refractory follicular helper T-cell lymphoma subjects. Subjects will receive golcadomide and oral 5-azacitidine until end of study or until disease progression, unacceptable toxicity, subject/physician decision to withdraw, whichever occurs first. Minimum 18 evaluable patient required.

Primary Outcome Measure

Modified Progression-Free Survival [ Time Frame: From enrollment to end of follow-up period of Origina-ly-T (= maximum 2 years after enrollment) ]

Central Contacts