Transplantation After Complete Response In Patients With T-cell Lymphoma
TRANSCRIPT
1 other identifier
interventional
204
1 country
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
September 28, 2023
September 1, 2023
5.7 years
June 8, 2022
September 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to assess if ASCT is associated with a significant prolongation of progression-free survival (PFS) for patient with peripheral T-cell lymphoma (PTCL) reaching a complete response (CR) according to the response critter
progression-free survival defined time from the date of randomization to the date of first documentation of relapse or progressive disease, death due to any cause, or receipt of subsequent systemic chemotherapy to treat residual or progressive peripheral T-cell lymphoma as determined by the investigator, whichever came first.
When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Secondary Outcomes (12)
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of Overall survival (OS)
When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of Overall response rate (ORR) and Complete Response Rate (CRR)
At the end of ASCT (8-12 weeks after post-induction evaluation)
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of duration of Response (DoR)
When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of time to next Treatment (TTNT)
When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of quality of Life
When the last randomized patient has reached two years of follow-up or when 154 events (progression/relapse/new anti-lymphoma treatment/death) occured whichever comes first
- +7 more secondary outcomes
Study Arms (2)
Chemotherapy
ACTIVE COMPARATORThe chemotherapy is one of the following regimen administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices and European Medical Agency (EMA) approval : * "Cyclophosphamide, doxorubicin, Vincristine and prednisone": (CHOP) * "Cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone": (CHOEP) * "Brentuximab vedotin, cyclophosphamide, doxorubicin, prednisone": (BV-CHP) for ALCL lymphoma only (based on EMA approval)
Chemotherapy + ASCT
ACTIVE COMPARATORChemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices: Patients with ASCT strategy in Complete Response after 6 cycles will receive a High Dose Therapy (HDT) composed of BCNU, etoposide, cytarabine and melphalan (BEAM) as conditioning regimen before transplantation. That consolidation phase will lasts between 2 to 3 months
Interventions
* 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
* 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
Eligibility Criteria
You may qualify if:
- Patient ≥ 18 years and \< 70 years of age at the time of signing the informed consent form (ICF)
- Patient fit enough to receive autologous stem cell transplant as a consolidation strategy as assessed by the local investigator
- 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
- Ann Arbor staging (I-IV) except stage I with normal LDH and PS\<2 (i.e. stage I aaIPI 0)
- 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)
- FFPE Diagnostic tissue block should be available for central pathology review and ancillary molecular analyses
- Participant with Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Estimated minimum life expectancy of 3 months
- Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
- Able to adhere to the study visit schedule and other protocol requirements
- Patient covered by any social security system (France)
- Patient who understands and speaks one of the country official languages
- +2 more criteria
You may not qualify if:
- Known central nervous system or meningeal involvement by lymphoma
- 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.
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Chu D'Amiens - Hopital Sud
Amiens, 80054, France
Chu D'Angers
Angers, 49933, France
Ch Victor Dupouy
Argenteuil, France
Ch D'Avignon - Hopital Henri Duffaut
Avignon, 84000, France
Ch de La Cote Basque
Bayonne, 64109, France
Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
Ch Metropole Savoie - Site Chambery
Chambéry, 73000, France
Chu Estaing
Clermont-Ferrand, France
Ch Alpes Leman
Contamine-sur-Arve, France
Hopital Henri Mondor
Créteil, 94010, France
René Olivier Casasnovas
Dijon, 21000, 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, 59020, France
Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,
Limoges, 87042, France
Centre Leon Berard
Lyon, 69373, France
Chu de Montpellier
Montpellier, France
Chu de Nantes
Nantes, France
Centre Antoine Lacassagne
Nice, 06189, France
Chu de Nimes - Hopital Caremeau
Nîmes, France
Chr Orleans
Orléans, France
Hopital Cochin
Paris, 75014, France
Hopital de La Pitie Salpetriere
Paris, 75651, France
Hopital Necker
Paris, 75743, 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, 69495, France
Ch Annecy Genevois
Pringy, France
Chu Pontchaillou_Rennes
Rennes, 35033, France
Ch de Roubaix - Hopital Victor Provo
Roubaix, France
Centre Henri Becquerel
Rouen, 76038, France
Service Hématologie, Institut Curie - Hôpital René HUGUENIN
Saint-Cloud, 92210, 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, 42270, 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, 54511, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuel BACHY, Pr
HCL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2022
First Posted
July 6, 2022
Study Start
August 1, 2022
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
September 28, 2023
Record last verified: 2023-09