Informations générales (source: ClinicalTrials.gov)
Transplantation After Complete Response In Patients With T-cell Lymphoma (TRANSCRIPT)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
août 2022
avril 2028
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Vincent RIBRAG | 08/03/2024 12:58:31 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Bénédicte DEAU-FISCHER | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | François LEMONNIER, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital La Pitié-Salpêtrière | Sylvain CHOQUET, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Necker-Enfants Malades | Ambroise MARCAIS, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Mohamad MOHTY, MD | Contact (sur clinicalTrials) | |||
| CH VICTOR DUPOUY ARGENTEUIL | Ahmad AL JIJAKLI, MD | Contact (sur clinicalTrials) | |||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Milena KOHN, MD | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | Carole SOUSSAIN, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Ch Alpes Leman - Contamine sur Arve - France | Blandine BOUTIN | Contact (sur clinicalTrials) | |||
| Ch Annecy Genevois - Pringy - France | Nicolas DAGUINDAU, MD | Contact (sur clinicalTrials) | |||
| Ch de Dunkerque - Dunkerque - France | Sarah BARBIEUX, MD | Contact (sur clinicalTrials) | |||
| Ch de Roubaix - Hopital Victor Provo - Roubaix - France | Julia HIEULLE, MD | Contact (sur clinicalTrials) | |||
| Ch de Valence - Valence - France | Clémence SANTANA, MD | Contact (sur clinicalTrials) | |||
| Ch Perigueux - Périgueux - France | Claire CALMETTES, MD | Contact (sur clinicalTrials) | |||
| Chr Orleans - Orléans - France | Marlène OCHMANN, MD | Contact (sur clinicalTrials) | |||
| Chu de La Reunion - Ghsr - Saint-Pierre - France | Hugo LEGENDRE, MD | Contact (sur clinicalTrials) | |||
| Chu de Nimes - Hopital Caremeau - Nîmes - France | Agathe WAULTIER - RASCALOU, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Frédéric PEYRADE, MD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - 76038 - Rouen - France | Vincent CAMUS, MD | Contact (sur clinicalTrials) | |||
| Centre Leon Berard - 69373 - Lyon - France | Yann GUILLERMIN | Contact (sur clinicalTrials) | |||
| Ch D'Avignon - Hopital Henri Duffaut - 84000 - Avignon - France | Hacène ZERAZHI | Contact (sur clinicalTrials) | |||
| Ch de La Cote Basque - 64109 - Bayonne - France | Sophie BERNARD, MD | Contact (sur clinicalTrials) | |||
| Ch de Perpignan - Perpignan - France | Sara BURCHERI, MD | Contact (sur clinicalTrials) | |||
| Ch de Saint-Quentin - Saint-Quentin - France | Réda GARIDI, Md | Contact (sur clinicalTrials) | |||
| Ch de Valenciennes - Hopital Jean Bernard - Valenciennes - France | Sabine TRICOT, MD | Contact (sur clinicalTrials) | |||
| Ch Metropole Savoie - Site Chambery - 73000 - Chambéry - France | Arthur DONY | Contact (sur clinicalTrials) | |||
| Chd de Vendee - La Roche-sur-Yon - France | Stéphane VIGOUROUX, MD | Contact (sur clinicalTrials) | |||
| Chu Brabois - 54511 - Vandœuvre-lès-Nancy - France | Charline MOULIN, MD | Contact (sur clinicalTrials) | |||
| Chu Bretonneau - Tours - France | Laurianne DRIEU LA ROCHELLE, MD | Contact (sur clinicalTrials) | |||
| Chu D'Amiens - Hopital Sud - 80054 - Amiens - France | Caroline DELETTE, MD | Contact (sur clinicalTrials) | |||
| Chu D'Angers - 49933 - Angers - France | Aline CLAVERT, MD | Contact (sur clinicalTrials) | |||
| Chu de Bordeaux - Hopital Haut-Leveque - Pessac - France | François-Xavier GROS, MD | Contact (sur clinicalTrials) | |||
| Chu de La Reunion - Hopital Felix Guyon - Saint-Denis - France | Marie DE CHARRETTE, MD | Contact (sur clinicalTrials) | |||
| Chu de Montpellier - Montpellier - France | Charles HERBAUX, Md | Contact (sur clinicalTrials) | |||
| Chu de Nantes - Nantes - France | Benoit TESSOULIN, Md | Contact (sur clinicalTrials) | |||
| CHU du Mans - Le Mans - France | Kamel LARIBI, MD | Contact (sur clinicalTrials) | |||
| Chu Estaing - Clermont-Ferrand - France | Olivier TOURNILHAC, MD | Contact (sur clinicalTrials) | |||
| CHU Francois MITTERRAND - Dijon - France | René-Olivier CASASNOVAS, MD | Contact (sur clinicalTrials) | |||
| Chu Lyon-Sud - 69495 - Pierre Benite - France | Emmanuel BACHY, MD | Contact (sur clinicalTrials) | |||
| Chu Pontchaillou_Rennes - 35033 - Rennes - France | Roch HOUOT, MD | Contact (sur clinicalTrials) | |||
| Hôpitaux Universitaires de Strasbourg - Strasbourg - France | Luc-Matthieu FORNECKER, MD | Contact (sur clinicalTrials) | |||
| Institut Cancerologie & Hematologie St-Etienne - 42270 - Saint-Priest-en-Jarez - France | Jérôme CORNILLON, MD | Contact (sur clinicalTrials) | |||
| Institut Universitaire du Cancer - Toulouse - France | Loïc YSEBAERT, MD | Contact (sur clinicalTrials) | |||
| René Olivier Casasnovas - 21000 - Dijon - France | Franck Morschhauser, MD | Contact (sur clinicalTrials) | |||
| Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine - 33300 - Bordeaux - France | Olivier FITOUSSI, MD | Contact (sur clinicalTrials) | |||
| Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN, - 87042 - Limoges - France | Julie ABRAHAM, MD | Contact (sur clinicalTrials) | |||
| Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL - 59020 - Lille - France | Sandy AMORIM, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
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