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

ConditionPeripheral T Cells Lymphoma (PTCL)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Lymphoma Academic Research Organisation

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted;

Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF);

Subject is willing and able to adhere to the study visit schedule and other protocol requirements;

Subject with histologically proven peripheral T-cell lymphoma according to the criteria of the WHO classification 2017 or 2022 (subjects with mycosis fungoides, Sezary syndrome, lymphoblastic or large granular lymphocytic lymphoma will be excluded). Tumor tissue (initial diagnosis or relapse) should be available for central pathology review and biological characterization;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • roginolisib

    Drug

    Roginolisib daily intake

  • golcadomide

    Drug

    Golcadomide daily intake

  • azacitidine

    Drug

    oral 5-azacitidine daily intake

Treatment groups

49 Participants
are divided into 2 treatment groups
Group A: Origina-ly-TExperimental treatment 1 intervention
Group B: GolcAzaExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Modified Progression-Free Survival

mPFS

Time frame
From enrollment to end of follow-up period of Origina-ly-T (= maximum 2 years after enrollment)
2

Maximum Tolerated Dose

MTD

Time frame
From enrollment to end of treatment of sub-study GolcAza (= maximum 2 years from enrollment)
3

Recommended Phase II Dose

RP2D

Time frame
From enrollment to end of treatment of sub-study GolcAza (= maximum 2 years from enrollment)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Lymphoma Academic Research Organisation

Lead sponsor

iOnctura

Collaborator

AbbVie

Collaborator

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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