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

NCT07018752 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-02-11

No results posted yet for this study

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

Conditions

  • Peripheral T Cells Lymphoma (PTCL)

Interventions

DRUG

roginolisib

Roginolisib daily intake

DRUG

golcadomide

Golcadomide daily intake

DRUG

azacitidine

oral 5-azacitidine daily intake

Sponsors & Collaborators

  • iOnctura

    collaborator INDUSTRY

  • AbbVie

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • François LEMONNIER, Pr · Hôpital Henri Mondor - Lymphoid Malignancies Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2028-04-30
Completion
2030-01-31

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07018752 on ClinicalTrials.gov