Peripheral T Cells Lymphoma (PTCL)Phase 1/2PlaTformNCT07018752
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
A Phase 1/2 study testing roginolisib, golcadomide and azacitidine in people with Peripheral T Cells Lymphoma (PTCL), run by The Lymphoma Academic Research Organisation at 20 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cells Lymphoma (PTCL)
- What is being tested?
- roginolisib, golcadomide and azacitidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 20 sitesFrance
- Study dates
- 20 Aug 2025to Jan 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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;.
Show all 32Show fewer
- 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
- Impaired renal function (calculated CKP-EPI, MDRD or Cockcroft-Gault Creatinine Clearance < 30 ml/min) or impaired liver function tests (serum total bilirubin level > 34 μmol/L), except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma, serum transaminases (AST or ALT) > 3 upper normal limits, unless elevated to up to 5 x ULN due to peripheral T-cells lymphoma);
- Significant cardiovascular disease [e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure | American Heart Association)], myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina);
- Prior exposure to PI3Kdelta inhibitor;
- Known or suspected allergies, hypersensitivity, or intolerance to Roginolisib or its excipients;
- Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications;
- Subjects with a diagnosis of cutaneous T-cell lymphoma (CTCL);
- Prior solid organ transplantation;
- 15. Evidence of positive HTLV1 serology;
- 16. 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;
- 17. Impaired renal function (calculated CKD-EPI, MDRD or Cockcroft-Gault Creatinine Clearance < 30 ml/min) or impaired liver function tests (serum total bilirubin level > 34 μmol/L) except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma, serum transaminases (AST or ALT) > 3 upper normal limits (except documented liver involvement by lymphoma);
- 18. Prior exposure to golcadomide;
- 19. Refractory to azacitidine;
- 20. Significant cardiovascular disease [e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure | American Heart Association)], myocardial infarction ≤ 3 months prior to starting golcadomide, unstable angina pectoris ≤ 3 months prior to starting golcadomide), or complete left bundle branch or bifascicular block), congenital long QT syndrome, QTcF ≥ 470 msec on screening, persistent or clinically meaningful ventricular arrhythmias;
- 21. Received strong CYP3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers, moderate CYP3A inducers within 7 days prior to initiation of study treatment;
- 22. Vaccinated with live, attenuated vaccines within 6 months of enrollment;
- 23. Known or suspected allergies, hypersensitivity, or intolerance to azacitidine, golcadomide or its excipients;
- 24. Any known malabsorption syndrome or disease associated with malabsorption.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 20 recruiting
- Recruiting
Institut d'Hématologie de Basse Normandie - Service Hématologie (CHU Hôpital Côte de Nacre)
Caen, 14000
Gandhi-Laurent DAMAJ, Pr
- Not yet recruiting
CHU Estaing - Service Thérapie Cellulaire et Hématologie Clinique
Clermont-Ferrand, 63100
Olivier TOURNILHAC, Pr
- Recruiting
Hôpital Henri Mondor - Unité Hémopathies Lymphoïdes
Créteil, 94000
François LEMONNIER, Pr
- Recruiting
CHU Dijon Bourgogne - Service Hématologie Clinique
Dijon, 21000
Steeve CHEVREUX, Dr
- Not yet recruiting
CHU de Grenoble - Service Hématologie
La Tronche, 38700
Sylvain CARRAS, Dr
- Not yet recruiting
CH du Mans - Centre de Cancérologie de la Sarthe - Service Hématologie
Le Mans, 72000
Kamel LARIBI, Dr
- Recruiting
CHU de Lille - Hôpital Claude Huriez - Service des Maladies du Sang
Lille, 59000
Doriane CAVALIERI, Dr
- Not yet recruiting
Institut Paoli Calmettes - Service Hématologie
Marseille, 13009
Robin NOEL, Dr
- Recruiting
CHU de Montpellier - Département d'Hématologie Clinique
Montpellier, 34080
Charles HERBAUX, Pr
- Recruiting
CHU de Nantes - Service Hématologie
Nantes, 44000
Benoit TESSOULIN, Dr
- Recruiting
Hôpital Necker - Service Hématologie Adultes
Paris, 75015
Morgane CHEMINANT, Dr
- Not yet recruiting
CHU de Bordeaux - Hôpital Haut-Lévêque - Centre François Magendie - Service d'Hématologie et Thérapie Cellulaire
Pessac, 33600
François-Xavier GROS, Dr
- Recruiting
CHU Lyon-Sud - Hématologie Clinique
Pierre-Bénite, 69310
Emmanuel BACHY, Dr
- Recruiting
CHU de Poitiers - Hôpital de la Milétrie - Service d'Oncologie Hématologique et Thérapie Cellulaire
Poitiers, 86000
Stéphanie GUIDEZ, Dr
- Not yet recruiting
CHU Pontchaillou - Hématologie Clinique
Rennes, 35000
Roch HOUOT, Pr
- Recruiting
Centre Henri Becquerel - Service Hématologie
Rouen, 76000
Vincent CAMUS, Dr
- Recruiting
Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie
Saint-Etienne, 42000
Jérôme CORNILLON, Dr
- Recruiting
CH de la Côte Basque - Service Hématologie
Saint-Jean-de-Luz, 64500
Sophie BERNARD, Dr
- Recruiting
Institut de Cancérologie Strasbourg Europe - Service Hématologie
Strasbourg, 67200
Luc-Matthieu FORNECKER, Pr
- Not yet recruiting
CHRU Nancy - Hôpital Brabois - Service Hématologie
Vandœuvre-lès-Nancy, 54500
Charline MOULIN, Dr
About this study
Official title: A Platform Trial, Evaluating New Drugs or Combination in Relapsed or Refractory Peripheral T-cell Lymphomas
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.
Read more
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
Read the detailed description
This study is a platform trial evaluating new drugs or combination of drugs in relapsed or refractory peripheral T-cell lymphomas via multiple sub-studies. For phase 1 sub-studies, at least 18 evaluable patients are required per each sub-study. For phase 2 sub-studies, 31 evaluable patients are required per sub-study.
Each sub-study has its own specificities:
- Origina-ly-T: open-label phase 2 study evaluating 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.
- GolcAza: open-label phase 1 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.
- Conditions
- Peripheral T Cells Lymphoma (PTCL)
- Being tested
- roginolisib, golcadomide, azacitidine
- Keywords
- lymphoma, peripheral T cells lymphoma, roginolisib, azacitidine, refractory peripheral T-cells lymphoma, relapsed peripheral T-cells lymphoma, golcadomide
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
roginolisibDrug
Roginolisib daily intake
golcadomideDrug
Golcadomide daily intake
azacitidineDrug
oral 5-azacitidine daily intake
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: golcadomide; Drug: azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Progression-Free Survival
mPFS
Measured: From enrollment to end of follow-up period of Origina-ly-T (= maximum 2 years after enrollment)
Maximum Tolerated Dose
MTD
Measured: From enrollment to end of treatment of sub-study GolcAza (= maximum 2 years from enrollment)
Recommended Phase II Dose
RP2D
Measured: From enrollment to end of treatment of sub-study GolcAza (= maximum 2 years from enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start20 Aug 2025
- Primary completionApr 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cells Lymphoma (PTCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Lymphoma Academic Research Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- iOnctura, AbbVie, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- François LEMONNIER, Pr, Principal investigator, Hôpital Henri Mondor - Lymphoid Malignancies Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018752
- Sponsor's protocol ID
- PlaTform
- Other IDs
- 2024-514954-63
- Acronym
- PlaTform
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Platform Trial, Evaluating New Drugs or Combination in Relapsed or Refractory Peripheral T-cell Lymphomas
- ClinicalTrials.gov ID
- NCT07018752
- Acronym / sponsor ID
- PlaTform / PlaTform
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- The Lymphoma Academic Research OrganisationUniversity, hospital or other
- Collaborators
- iOnctura, AbbVie, Bristol-Myers Squibb
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study is a platform trial evaluating new drugs or combination of drugs in relapsed or refractory peripheral T-cell lymphomas via multiple sub-studies. For phase 1 sub-studies, at least 18 evaluable patients are required per each sub-study. For phase 2 sub-studies, 31 evaluable patients are required per sub-study.
Each sub-study has its own specificities:
- Origina-ly-T: open-label phase 2 study evaluating 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.
- GolcAza: open-label phase 1 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Origina-ly-T | Experimental | Drug: roginolisibOpen-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. |
| GolcAza | Experimental | Drug: golcadomide, Drug: azacitidineOpen-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (32 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| roginolisibRoginolisib daily intake | Drug | Origina-ly-T |
| golcadomideGolcadomide daily intake | Drug | GolcAza |
| azacitidineoral 5-azacitidine daily intake | Drug | GolcAza |
Primary outcome
Modified Progression-Free Survival
Time frame: From enrollment to end of follow-up period of Origina-ly-T (= maximum 2 years after enrollment)
mPFS
Maximum Tolerated Dose
Time frame: From enrollment to end of treatment of sub-study GolcAza (= maximum 2 years from enrollment)
MTD
Recommended Phase II Dose
Time frame: From enrollment to end of treatment of sub-study GolcAza (= maximum 2 years from enrollment)
RP2D
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François LEMONNIER, Pr principal investigator
Hôpital Henri Mondor - Lymphoid Malignancies Unit
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing roginolisib, golcadomide and azacitidine in people with Peripheral T Cells Lymphoma (PTCL), run by The Lymphoma Academic Research Organisation at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Project Manager (+33 4 72 66 93 33, platform@lysarc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.