Transplantation for patients with T-cell lymphoma who have achieved complete response
Official title: Transplantation After Complete Response In Patients With T-cell Lymphoma
Run by Hospices Civils de Lyon · NCT05444712 · Data updated 2026-11-12
This study is testing whether a stem cell transplant can help adults with T-cell lymphoma who have responded well to chemotherapy feel better and live longer compared to just continuing with chemotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 204 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | cyclophosphamide, prednisone |
| Locations | 48 sites (Amiens and 47 other locations) |
| Status | Recruiting |
| Started | August 1, 2022 |
| Main results expected | April 1, 2028 |
| Study ends | April 1, 2028 |
| Registry record updated | September 28, 2023 |
| Trial ID | NCT05444712 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 70 with histologically confirmed nodal-type peripheral T-cell lymphoma who have achieved a complete metabolic response after chemotherapy.
✕Probably not a fit
Patients with advanced-stage disease or those who have previously received treatment for PTCL may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of autologous stem cell transplantation (ASCT) as a consolidation treatment for patients with peripheral T-cell lymphoma (PTCL) who have achieved a complete metabolic response after initial chemotherapy. The study aims to determine whether ASCT can improve outcomes compared to chemotherapy alone. Eligible participants include adults aged 18 to 70 with specific subtypes of PTCL, who meet certain health criteria. The trial will assess the safety and efficacy of the intervention through follow-up evaluations.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with peripheral T-cell lymphoma.
How similar studies have gone: Other studies have shown promising results for autologous stem cell transplantation in similar patient populations, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient ≥ 18 years and \< 70 years of age at the time of signing the informed consent form (ICF) 2. Patient fit enough to receive autologous stem cell transplant as a consolidation strategy as assessed by the local investigator 3. Hemoglobin level \> 8g/dL (transfusion allowed); Neutrophil count \>0.5 G/L; Platelets count \> 50 G/L (transfusion allowed) Patient with histologically proven "nodal-type peripheral T-cell lymphoma (PTCL)" (latest WHO classification), not previously treated; as defined by the WHO classification, the following subtypes may be included, * PTCL, not otherwise specified * Follicular helper T-cell lymphomas: Angioimmunoblastic T-cell lymphoma and nodal PTCL with TFH phenotype and follicular T-cell lymphoma * Anaplastic large cell lymphoma, ALK-negative 4. Ann Arbor staging (I-IV) except stage I with normal LDH and PS\<2 (i.e. stage I aaIPI 0) 5. Participant with a measurable disease by the Lugano criteria (i.e., longest diameter of a nodal site \> 1.5 cm and/or longest diameter of an extranodal site \> 1.0 cm and/or a hypermetabolic lesion) 6. FFPE Diagnostic tissue block should be available for central pathology review and ancillary molecular analyses 7. Participant with Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 8. Estimated minimum life expectancy of 3 months 9. Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted 10. Able to adhere to the study visit schedule and other protocol requirements 11. Patient covered by any social security system (France) 12. Patient who understands and speaks one of the country official languages 13. Males with partners of childbearing potential must agree to use effective birth control methods during the study as informed by the investigator in accordance with SmPC of each drugs administrated 14. Females of childbearing potential must agree to use effective birth control methods for at least 28 days before starting treatment; while participating in the study; during treatment interruptions and necessary period after the study as informed by the investigator in accordance with SmPC of each drugs administrated Exclusion Criteria: 1. Known central nervous system or meningeal involvement by lymphoma 2. Impaired renal function (calculated MDRD or Cockcroft-Gault Creatinine Clearance \< 30 ml/min) or impaired liver function tests (serum total bilirubin level \> 2.0 mg/dl \[34 µmol/L\] (except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma), serum transaminases (AST or ALT) \> 3 upper normal limit unless they are related to the lymphoma. 3. The following types of T-cell lymphomas: * Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma) * Extranodal T-cell/NK-cell lymphoma, nasal type * Anaplastic large cell lymphoma, ALK-positive type * Cutaneous T cell lymphoma (mycosis fungoides, Sézary syndrome) * Primary cutaneous CD30+ T-cell lymphoproliferative disorder * Primary cutaneous anaplastic T-cell lymphoma * Enteropathy-associated T-cell lymphoma * Hepatosplenic T-cell lymphoma * Subcutaneous panniculitis-like T-cell lymphoma * Primary cutaneous gamma-delta T-cell lymphoma * Primary cutaneous CD8+ aggressive epidermotropic lymphoma * Primary cutaneous CD4+ small/medium T-cell lymphoma 4. Active malignancy other than the one treated in this research. Prior history of malignancies unless the patient has been free of the disease for ≥ 2 years. However, patients with the following history are allowed: 1. Basal or squamous cell carcinoma of the skin 2. Carcinoma in situ of the cervix 3. Carcinoma in situ of the breast 4. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis clinical staging system 5. Vaccinated with live, attenuated vaccines within 6 months of enrollment 6. Use of any standard or experimental anti-cancer drug therapy before the start of treatment except COP (cyclophosphamide, vincristine, prednisone) in case of (or high risk of tumor lysis syndrome) or etoposide for a maximum of 3 doses (at a maximum dose of 150mg/m2) for HLH (Hemophagocytic Lymphohistiocytosis). 7. A corticosteroids therapy \> 1mg/kg lasting more than 14 days prior to Cycle 1 Day 1 8. Positive serology for Human Immunodeficiency Virus (HIV) and Human T-Lymphotrophic Virus (HTLV1) 15\. Active Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infections defined as: * HBV : * HBs Ag positive * HBs Ag negative, anti-HBs antibody positive and anti-HBc antibody positive with detectable viral DNA * HCV : Anti-VHC antibody positive with detectable viral RNA 9. Pregnant, planning to become pregnant or lactating WOCBP 10. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with the participation in this clinical study (according to the investigator's decision) 11. Person deprived of his/her liberty by a judicial or administrative decision 12. Person hospitalized without consent 13. Adult person under legal protection
Where it's running
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Chu Lyon-Sud
Pierre-Bénite, France Recruiting -
Chu D'Amiens - Hopital Sud
Amiens, France Not yet recruiting -
Chu D'Angers
Angers, France Not yet recruiting -
Ch Victor Dupouy
Argenteuil, France Not yet recruiting -
Ch D'Avignon - Hopital Henri Duffaut
Avignon, France Not yet recruiting -
Ch de La Cote Basque
Bayonne, France Not yet recruiting
Show 42 more locations
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Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France Not yet recruiting -
Ch Metropole Savoie - Site Chambery
Chambéry, France Not yet recruiting -
Chu Estaing
Clermont-Ferrand, France Not yet recruiting -
Ch Alpes Leman
Contamine-sur-Arve, France Not yet recruiting -
Hopital Henri Mondor
Créteil, France Not yet recruiting -
René Olivier Casasnovas
Dijon, France Not yet recruiting -
CHU Francois MITTERRAND
Dijon, France Not yet recruiting -
Ch de Dunkerque
Dunkirk, France Not yet recruiting -
Chd de Vendee
La Roche-sur-Yon, France Not yet recruiting -
Ch de Versailles - Hopital Andre Mignot
Le Chesnay, France Not yet recruiting -
CHU du Mans
Le Mans, France Not yet recruiting -
Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL
Lille, France Not yet recruiting -
Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,
Limoges, France Not yet recruiting -
Centre Leon Berard
Lyon, France Not yet recruiting -
Chu de Montpellier
Montpellier, France Not yet recruiting -
Chu de Nantes
Nantes, France Not yet recruiting -
Centre Antoine Lacassagne
Nice, France Not yet recruiting -
Chu de Nimes - Hopital Caremeau
Nîmes, France Not yet recruiting -
Chr Orleans
Orléans, France Not yet recruiting -
Hopital Cochin
Paris, France Not yet recruiting -
Hopital de La Pitie Salpetriere
Paris, France Not yet recruiting -
Hopital Necker
Paris, France Not yet recruiting -
Hopital Saint Antoine
Paris, France Not yet recruiting -
Ch de Perpignan
Perpignan, France Not yet recruiting -
Chu de Bordeaux - Hopital Haut-Leveque
Pessac, France Not yet recruiting -
Ch Perigueux
Périgueux, France Not yet recruiting -
Ch Annecy Genevois
Pringy, France Not yet recruiting -
Chu Pontchaillou_Rennes
Rennes, France Not yet recruiting -
Ch de Roubaix - Hopital Victor Provo
Roubaix, France Not yet recruiting -
Centre Henri Becquerel
Rouen, France Not yet recruiting -
Service Hématologie, Institut Curie - Hôpital René HUGUENIN
Saint-Cloud, France Not yet recruiting -
Chu de La Reunion - Hopital Felix Guyon
Saint-Denis, France Not yet recruiting -
Chu de La Reunion - Ghsr
Saint-Pierre, France Not yet recruiting -
Institut Cancerologie & Hematologie St-Etienne
Saint-Priest-en-Jarez, France Not yet recruiting -
Ch de Saint-Quentin
Saint-Quentin, France Not yet recruiting -
Hôpitaux Universitaires de Strasbourg
Strasbourg, France Not yet recruiting -
Institut Universitaire du Cancer
Toulouse, France Not yet recruiting -
Chu Bretonneau
Tours, France Not yet recruiting -
Ch de Valence
Valence, France Not yet recruiting -
Ch de Valenciennes - Hopital Jean Bernard
Valenciennes, France Not yet recruiting -
Chu Brabois
Vandœuvre-lès-Nancy, France Not yet recruiting -
Institut Gustave Roussy
Villejuif, France Not yet recruiting
Study contacts
- Principal investigator: Emmanuel BACHY, Pr — Hcl
- Study coordinator: Emmanuel BACHY, Pr
- Email: emmanuel.bachy@chu-lyon.fr
- Phone: +33(0) 4 78 86 22 05
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XNW5004 with CHOP/CHOEP in Untreated Peripheral T-Cell Lymphoma
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Treatment options for peripheral T‑cell lymphoma after no response to first‑line therapy
This project will try allogeneic stem cell transplant versus other salvage treatments for adults with peripheral T‑cell lymphoma who did not respond to first‑line chemotherapy.
-
Golidocitinib versus placebo as maintenance treatment for PTCL patients in remission after first-line chemotherapy
This trial tests whether taking golidocitinib every other day can help keep peripheral T‑cell lymphoma from coming back in adults who responded to first‑line chemotherapy but cannot have a stem cell transplant.
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Cidabenamine plus azacitidine to prevent post-transplant progression in high-risk peripheral T‑cell lymphoma
This trial will test whether adding cidabenamine to azacitidine after allogeneic stem cell transplant can help prevent progression in adults with high‑risk peripheral T‑cell lymphoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.