RecruitingNot ApplicableNCT05444712

Transplantation After Complete Response In Patients With T-cell Lymphoma


Sponsor

Hospices Civils de Lyon

Enrollment

204 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Peripheral T-cell lymphoma (PTCL) encompasses a broad range of post-thymic (i.e., mature) sub-entities as defined by the 2017 WHO classification. The most common entities are angioimmunoblastic T-cell lymphoma (AITL) and other Tfh-phenotype PTCL or PTCL not otherwise specified (NOS), each representing approximately 20 to 25% of mature T- and NK/T-cell lymphomas. Compared to their B-cell counterparts, most PTCL confer dismal prognosis. In fact, except for anaplastic lymphoma kinase (ALK)-positive systemic anaplastic large cell lymphoma (sALCL), 10-year overall survival for patients with PTCL barely exceeds 30%. Given the infrequency and the heterogeneity of these malignancies, no real consensus on first-line treatment has been established for most PTCL. The place of autologous stem cell transplantation (ASCT) as a consolidation procedure for patients with PTCL achieving a complete metabolic response after induction is still highly debated. ESMO recommendations and recent guidelines from a committee of the American Society for Blood and Marrow Transplantation currently propose ASCT as first-line therapy for transplant-eligible patients for all patients reaching at least a partial response (PR) after induction. NCCN guidelines (version 2.2017) recommend ASCT or observation in case of metabolic CR but salvage regimen in case of residual disease after induction.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving an autologous stem cell transplant (using your own stem cells) as consolidation therapy — after achieving a complete response to first-line treatment — improves outcomes for patients with a type of blood cancer called peripheral T-cell lymphoma (PTCL). **You may be eligible if...** - You are between 18 and 70 years old - You have been newly diagnosed with nodal-type peripheral T-cell lymphoma (PTCL) - You have not previously been treated for this cancer - You are healthy enough to receive a stem cell transplant - Your blood counts meet minimum requirements **You may NOT be eligible if...** - You have already received prior treatment for PTCL - You are not physically fit enough for a stem cell transplant - You have a type of PTCL not included in the study subtypes - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREChemotherapy + follow up

* Chemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices. * An intermediate evaluation will be performed after four cycles by PET-CT (or CT-Scan for non-avid PTCL) * A post-induction evaluation by PET-CT or CT-Scan will be done between 3 and 5 weeks after the last chemotherapy drug administration for all patients * A last evaluation by PET-CT or CT-Scan will be done between 08 and 12 weeks after the post-induction for all patients

PROCEDUREChemotherapy + ASCT + follow up

* Chemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices. * An intermediate evaluation will be performed after four cycles by PET-CT (or CT-Scan for non-avid PTCL) * The fifth or sixth cycles should be used as stem-cell mobilizing chemotherapy for patients with ASCT strategy * A post-induction evaluation by PET-CT or CT-Scan will be done between 3 and 5 weeks after the last chemotherapy drug administration for all patients * Patients with in Complete Response after 6 cycles will receive a High Dose Therapy as conditioning regimen before transplantation * A last evaluation by PET-CT or CT-Scan will be done between 08 and 12 weeks after the post-induction for all patients


Locations(48)

Chu D'Amiens - Hopital Sud

Amiens, France

Chu D'Angers

Angers, France

Ch Victor Dupouy

Argenteuil, France

Ch D'Avignon - Hopital Henri Duffaut

Avignon, France

Ch de La Cote Basque

Bayonne, France

Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

Ch Metropole Savoie - Site Chambery

Chambéry, France

Chu Estaing

Clermont-Ferrand, France

Ch Alpes Leman

Contamine-sur-Arve, France

Hopital Henri Mondor

Créteil, France

René Olivier Casasnovas

Dijon, France

CHU Francois MITTERRAND

Dijon, France

Ch de Dunkerque

Dunkirk, France

Chd de Vendee

La Roche-sur-Yon, France

Ch de Versailles - Hopital Andre Mignot

Le Chesnay, France

CHU du Mans

Le Mans, France

Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL

Lille, France

Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,

Limoges, France

Centre Leon Berard

Lyon, France

Chu de Montpellier

Montpellier, France

Chu de Nantes

Nantes, France

Centre Antoine Lacassagne

Nice, France

Chu de Nimes - Hopital Caremeau

Nîmes, France

Chr Orleans

Orléans, France

Hopital Cochin

Paris, France

Hopital de La Pitie Salpetriere

Paris, France

Hopital Necker

Paris, France

Hopital Saint Antoine

Paris, France

Ch de Perpignan

Perpignan, France

Chu de Bordeaux - Hopital Haut-Leveque

Pessac, France

Ch Perigueux

Périgueux, France

Chu Lyon-Sud

Pierre-Bénite, France

Ch Annecy Genevois

Pringy, France

Chu Pontchaillou_Rennes

Rennes, France

Ch de Roubaix - Hopital Victor Provo

Roubaix, France

Centre Henri Becquerel

Rouen, France

Service Hématologie, Institut Curie - Hôpital René HUGUENIN

Saint-Cloud, France

Chu de La Reunion - Hopital Felix Guyon

Saint-Denis, France

Chu de La Reunion - Ghsr

Saint-Pierre, France

Institut Cancerologie & Hematologie St-Etienne

Saint-Priest-en-Jarez, France

Ch de Saint-Quentin

Saint-Quentin, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Institut Universitaire du Cancer

Toulouse, France

Chu Bretonneau

Tours, France

Ch de Valence

Valence, France

Ch de Valenciennes - Hopital Jean Bernard

Valenciennes, France

Chu Brabois

Vandœuvre-lès-Nancy, France

Institut Gustave Roussy

Villejuif, France

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NCT05444712


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