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

NCT07018752 | Recruiting Phase 1 DMC

• 2 other identifiers: PlaTform2024-514954-63
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 20

Brief 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)

Keywords

lymphoma; peripheral T cells lymphoma; roginolisib; azacitidine; refractory peripheral T-cells lymphoma; relapsed peripheral T-cells lymphoma; golcadomide

Outcome Measures

Primary Outcomes (3)

• Modified Progression-Free Survival

  mPFS

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

• Maximum Tolerated Dose

  MTD

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

• Recommended Phase II Dose

  RP2D

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

Study Arms (2)

Origina-ly-T

EXPERIMENTAL

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.

Drug: roginolisib

GolcAza

EXPERIMENTAL

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.

Drug: golcadomide; Drug: azacitidine

Interventions

roginolisib DRUG

Roginolisib daily intake

Origina-ly-T

golcadomide DRUG

Golcadomide daily intake

GolcAza

azacitidine DRUG

oral 5-azacitidine daily intake

GolcAza

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \. Subject had local diagnosed (nodal) follicular helper T cell lymphoma according to WHO classification 2022 or ICC 2022 classification based on a surgical lymph node biopsy or needle core biopsy including any one of the following type:
• angioimmunoblastic type (AITL)
• follicular T cell type
• not otherwise specified (NOS);
• \. ECOG performance status 0 to 1 (supersedes criterium 6 of the Master protocol);
• \. Subjects must have an international normalized ratio (INR) \< 1.5 x ULN and partial thromboplastin time (aPTT) \< 1.5 x ULN (for subjects not receiving therapy). Note: Subjects receiving therapy for a thromboembolic event that occurred \> 3months prior to enrollment are eligible as long as they are on a stable regimen of anticoagulation with warfarin, low-molecular weight heparin, or other approved therapeutic anticoagulation or antiplatelet regimen;
• \. Contraception (supersedes criterium 10 of the Master protocol):
• For women of childbearing potential (WOCBP): must have a negative result for pregnancy test, 10 to 14 days prior to initiating study treatment and within 24 hours prior to initiating study treatment. WOCBP agree to abstain from becoming pregnant or breastfeeding and to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one highly effective method of contraception , at least 28 days before the first dose of study treatment , during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide, and 6 months after the last dose of azacitidine. Women must refrain from donating eggs during this same period;
• For men: during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide and 3 months after the last dose of oral 5-azacitidine male subjects must:
• With female partners of childbearing potential: use a condom associated with a highly effective method of contraception or remain abstinent (refrain from heterosexual intercourse)
• With pregnant female partners: use a condom or remain abstinent (refrain from heterosexual intercourse) Men must refrain from donating sperm during this same period;

You may not qualify if:

• 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;.
• 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;
• 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;
• Subject with major surgery ≤ 14 days prior to starting investigational product(s). Subjects must have recovered from any clinically significant effects of recent surgery;
• Subject who has received prior localized anticancer therapy (eg. radiotherapy \[including palliative radiotherapy\]) ≤ 14 days prior to starting investigational product(s);
• Known or suspected hypersensitivity to active substance or to any of the excipients;
• Pregnant, planning to become pregnant, or lactating woman;
• Person deprived of his/her liberty by a judicial or administrative decision;
• Positive HIV test at screening, with the following exception: individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to HIV within the last 12 months

Sponsors & Collaborators

• Bristol-Myers Squibb: collaborator
• The Lymphoma Academic Research Organisation: lead
• iOnctura: collaborator
• AbbVie: collaborator

Study Sites (20)

Institut d'Hématologie de Basse Normandie - Service Hématologie (CHU Hôpital Côte de Nacre)

Caen, 14000, France

RECRUITING

CHU Estaing - Service Thérapie Cellulaire et Hématologie Clinique

Clermont-Ferrand, 63100, France

NOT YET RECRUITING

Hôpital Henri Mondor - Unité Hémopathies Lymphoïdes

Créteil, 94000, France

RECRUITING

CHU Dijon Bourgogne - Service Hématologie Clinique

Dijon, 21000, France

RECRUITING

CHU de Grenoble - Service Hématologie

La Tronche, 38700, France

NOT YET RECRUITING

CH du Mans - Centre de Cancérologie de la Sarthe - Service Hématologie

Le Mans, 72000, France

NOT YET RECRUITING

CHU de Lille - Hôpital Claude Huriez - Service des Maladies du Sang

Lille, 59000, France

RECRUITING

Institut Paoli Calmettes - Service Hématologie

Marseille, 13009, France

NOT YET RECRUITING

CHU de Montpellier - Département d'Hématologie Clinique

Montpellier, 34080, France

RECRUITING

CHU de Nantes - Service Hématologie

Nantes, 44000, France

RECRUITING

Hôpital Necker - Service Hématologie Adultes

Paris, 75015, France

RECRUITING

CHU de Bordeaux - Hôpital Haut-Lévêque - Centre François Magendie - Service d'Hématologie et Thérapie Cellulaire

Pessac, 33600, France

NOT YET RECRUITING

CHU Lyon-Sud - Hématologie Clinique

Pierre-Bénite, 69310, France

RECRUITING

CHU de Poitiers - Hôpital de la Milétrie - Service d'Oncologie Hématologique et Thérapie Cellulaire

Poitiers, 86000, France

RECRUITING

CHU Pontchaillou - Hématologie Clinique

Rennes, 35000, France

NOT YET RECRUITING

Centre Henri Becquerel - Service Hématologie

Rouen, 76000, France

RECRUITING

Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie

Saint-Etienne, 42000, France

RECRUITING

CH de la Côte Basque - Service Hématologie

Saint-Jean-de-Luz, 64500, France

RECRUITING

Institut de Cancérologie Strasbourg Europe - Service Hématologie

Strasbourg, 67200, France

RECRUITING

CHRU Nancy - Hôpital Brabois - Service Hématologie

Vandœuvre-lès-Nancy, 54500, France

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• François LEMONNIER, Pr

  Hôpital Henri Mondor - Lymphoid Malignancies Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Project Manager

CONTACT

+33 4 72 66 93 33; platform@lysarc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiples arms/sub-studies will be opened in parallel and/or successively. The number of arms/sub-studies will be increasing throughout the study and is not a fixed number.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 11, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (20)