Actively Recruiting
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Led by The Lymphoma Academic Research Organisation · Updated on 2026-02-11
49
Participants Needed
20
Research Sites
227 weeks
Total Duration
On this page
Sponsors
T
The Lymphoma Academic Research Organisation
Lead Sponsor
I
iOnctura
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
- Subject is 63; 18 years of age at the time of signing the informed consent form
- 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 WHO classification 2017 or 2022 (excluding mycosis fungoides, Sezary syndrome, lymphoblastic or large granular lymphocytic lymphoma)
- Subject in relapse or refractory situation
- ECOG performance status 0 to 2, or 3 if thought related to lymphoma
- Adequate bone marrow function: Absolute Neutrophil Count 63; 1.5 x 10^9/L (or 63; 1 x 10^9/L if related to lymphoma), Platelets 63; 75 x 10^9/L (or 63; 50 x 10^9/L if related to lymphoma), Hemoglobin 63; 8 g/dL
- Anticipated life expectancy at least 3 months
- Presence of disease-specific criteria allowing response evaluation including FDG-PET scan positive lesion and measurable nodal or extranodal lesion
- Contraception requirements for women of childbearing potential and men of reproductive potential as specified
- Subject covered by a social security system
- Subject who understands and speaks one of the country official languages unless local regulation authorizes independent translators
- Additional specific criteria for Origina-ly-T: for anaplastic large cell lymphoma failed/ineligible/intolerant to brentuximab vedotin; for extranodal NK/T-cell lymphoma failed/ineligible/intolerant to asparaginase-containing regimen
- Additional specific criteria for GolcAza: diagnosed follicular helper T cell lymphoma subtype, ECOG 0 to 1, INR and aPTT within specified limits, contraception requirements specific to GolcAza
You will not qualify if you...
- Evidence of central nervous system involvement by lymphoma
- Significant medical conditions, laboratory abnormalities, or psychiatric illness interfering with participation
- Uncontrolled systemic infections
- Known active Hepatitis B or C infection with detectable viral load
- Active malignancy other than treated disease unless disease-free for 2 years (except certain skin cancers)
- Use of anti-cancer therapy within 28 days or 5 half-lives prior to study drug
- Use of corticosteroids above specified dose within 14 days prior to study drug
- Prior autologous hematopoietic cell transplant within 3 months or unresolved toxicity
- Prior allogeneic hematopoietic cell transplant within 3 months or unresolved complications
- Major surgery within 14 days prior to study drug
- Prior localized anticancer therapy within 14 days
- Known or suspected hypersensitivity to study drugs or excipients
- Pregnant, planning pregnancy, or lactating women
- Persons deprived of liberty by judicial or administrative decision
- Additional exclusions specific to Origina-ly-T: positive HIV test unless stable on therapy, impaired renal or liver function, significant cardiovascular disease, prior PI3Kdelta inhibitor exposure, allergies to roginolisib, inability to swallow oral medications, cutaneous T-cell lymphoma diagnosis, prior solid organ transplant
- Additional exclusions specific to GolcAza: positive HTLV1 serology, positive HIV test unless stable on therapy, impaired renal or liver function, prior golcadomide exposure, refractory to azacitidine, significant cardiovascular disease, recent use of CYP3A modulators, recent live attenuated vaccine, allergies to azacitidine or golcadomide, malabsorption syndromes or diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Institut d'Hématologie de Basse Normandie - Service Hématologie (CHU Hôpital Côte de Nacre)
Caen, France, 14000
Actively Recruiting
2
CHU Estaing - Service Thérapie Cellulaire et Hématologie Clinique
Clermont-Ferrand, France, 63100
Not Yet Recruiting
3
Hôpital Henri Mondor - Unité Hémopathies Lymphoïdes
Créteil, France, 94000
Actively Recruiting
4
CHU Dijon Bourgogne - Service Hématologie Clinique
Dijon, France, 21000
Actively Recruiting
5
CHU de Grenoble - Service Hématologie
La Tronche, France, 38700
Not Yet Recruiting
6
CH du Mans - Centre de Cancérologie de la Sarthe - Service Hématologie
Le Mans, France, 72000
Not Yet Recruiting
7
CHU de Lille - Hôpital Claude Huriez - Service des Maladies du Sang
Lille, France, 59000
Actively Recruiting
8
Institut Paoli Calmettes - Service Hématologie
Marseille, France, 13009
Not Yet Recruiting
9
CHU de Montpellier - Département d'Hématologie Clinique
Montpellier, France, 34080
Actively Recruiting
10
CHU de Nantes - Service Hématologie
Nantes, France, 44000
Actively Recruiting
11
Hôpital Necker - Service Hématologie Adultes
Paris, France, 75015
Actively Recruiting
12
CHU de Bordeaux - Hôpital Haut-Lévêque - Centre François Magendie - Service d'Hématologie et Thérapie Cellulaire
Pessac, France, 33600
Not Yet Recruiting
13
CHU Lyon-Sud - Hématologie Clinique
Pierre-Bénite, France, 69310
Actively Recruiting
14
CHU de Poitiers - Hôpital de la Milétrie - Service d'Oncologie Hématologique et Thérapie Cellulaire
Poitiers, France, 86000
Actively Recruiting
15
CHU Pontchaillou - Hématologie Clinique
Rennes, France, 35000
Not Yet Recruiting
16
Centre Henri Becquerel - Service Hématologie
Rouen, France, 76000
Actively Recruiting
17
Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie
Saint-Etienne, France, 42000
Actively Recruiting
18
CH de la Côte Basque - Service Hématologie
Saint-Jean-de-Luz, France, 64500
Actively Recruiting
19
Institut de Cancérologie Strasbourg Europe - Service Hématologie
Strasbourg, France, 67200
Actively Recruiting
20
CHRU Nancy - Hôpital Brabois - Service Hématologie
Vandœuvre-lès-Nancy, France, 54500
Not Yet Recruiting
Research Team
C
Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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