Phase
Condition
Non-hodgkin's Lymphoma
Lymphoma
Treatment
Chemotherapy + follow up
Chemotherapy + ASCT + follow up
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient ≥ 18 years and < 70 years of age at the time of signing the informed consentform (ICF)
- Patient fit enough to receive autologous stem cell transplant as a consolidationstrategy as assessed by the local investigator
- Hemoglobin level > 8g/dL (transfusion allowed); Neutrophil count >0.5 G/L; Plateletscount > 50 G/L (transfusion allowed) Patient with histologically proven "nodal-typeperipheral T-cell lymphoma (PTCL)" (latest WHO classification), not previouslytreated; 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 nodalPTCL 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
- Participant with a measurable disease by the Lugano criteria (i.e., longest diameterof a nodal site > 1.5 cm and/or longest diameter of an extranodal site > 1.0 cm and/ora hypermetabolic lesion)
- FFPE Diagnostic tissue block should be available for central pathology review andancillary 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 toany 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
- Males with partners of childbearing potential must agree to use effective birthcontrol methods during the study as informed by the investigator in accordance withSmPC of each drugs administrated
- Females of childbearing potential must agree to use effective birth control methodsfor at least 28 days before starting treatment; while participating in the study;during treatment interruptions and necessary period after the study as informed by theinvestigator in accordance with SmPC of each drugs administrated
Exclusion
Exclusion Criteria:
- Known central nervous system or meningeal involvement by lymphoma
- Impaired renal function (calculated MDRD or Cockcroft-Gault Creatinine Clearance < 30ml/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 pancreaticinvolvement by lymphoma), serum transaminases (AST or ALT) > 3 upper normal limitunless 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
- Active malignancy other than the one treated in this research. Prior history ofmalignancies unless the patient has been free of the disease for ≥ 2 years. However,patients with the following history are allowed:
- Basal or squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor,nodes, metastasis clinical staging system
- Vaccinated with live, attenuated vaccines within 6 months of enrollment
- Use of any standard or experimental anti-cancer drug therapy before the start oftreatment except COP (cyclophosphamide, vincristine, prednisone) in case of (or highrisk of tumor lysis syndrome) or etoposide for a maximum of 3 doses (at a maximum doseof 150mg/m2) for HLH (Hemophagocytic Lymphohistiocytosis).
- A corticosteroids therapy > 1mg/kg lasting more than 14 days prior to Cycle 1 Day 1
- Positive serology for Human Immunodeficiency Virus (HIV) and Human T-LymphotrophicVirus (HTLV1)
- 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 withdetectable viral DNA
- HCV : Anti-VHC antibody positive with detectable viral RNA 9. Pregnant, planning to becomepregnant or lactating WOCBP 10. Any significant medical conditions, laboratory abnormalityor 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 ajudicial or administrative decision 12. Person hospitalized without consent 13. Adultperson under legal protection
Study Design
Connect with a study center
Chu D'Amiens - Hopital Sud
Amiens, 80054
FranceSite Not Available
Chu D'Angers
Angers, 49933
FranceSite Not Available
Ch Victor Dupouy
Argenteuil,
FranceSite Not Available
Ch D'Avignon - Hopital Henri Duffaut
Avignon, 84000
FranceSite Not Available
Ch de La Cote Basque
Bayonne, 64109
FranceSite Not Available
Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
FranceSite Not Available
Ch Metropole Savoie - Site Chambery
Chambéry, 73000
FranceSite Not Available
Chu Estaing
Clermont-Ferrand,
FranceSite Not Available
Ch Alpes Leman
Contamine sur Arve,
FranceSite Not Available
Hopital Henri Mondor
Creteil, 94010
FranceSite Not Available
CHU Francois MITTERRAND
Dijon,
FranceSite Not Available
René Olivier Casasnovas
Dijon, 21000
FranceSite Not Available
Ch de Dunkerque
Dunkerque,
FranceSite Not Available
Chd de Vendee
La Roche-sur-Yon,
FranceSite Not Available
Ch de Versailles - Hopital Andre Mignot
Le Chesnay,
FranceSite Not Available
CHU du Mans
Le Mans,
FranceSite Not Available
Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL
Lille, 59020
FranceSite Not Available
Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,
Limoges, 87042
FranceSite Not Available
Centre Leon Berard
Lyon, 69373
FranceSite Not Available
Chu de Montpellier
Montpellier,
FranceSite Not Available
Chu de Nantes
Nantes,
FranceSite Not Available
Centre Antoine Lacassagne
Nice, 06189
FranceSite Not Available
Chu de Nimes - Hopital Caremeau
Nîmes,
FranceSite Not Available
Chr Orleans
Orléans,
FranceSite Not Available
Hopital Cochin
Paris, 75014
FranceSite Not Available
Hopital Necker
Paris, 75743
FranceSite Not Available
Hopital Saint Antoine
Paris,
FranceSite Not Available
Hopital de La Pitie Salpetriere
Paris, 75651
FranceSite Not Available
Ch de Perpignan
Perpignan,
FranceSite Not Available
Chu de Bordeaux - Hopital Haut-Leveque
Pessac,
FranceSite Not Available
Chu Lyon-Sud
Pierre Benite, 69495
FranceActive - Recruiting
Ch Annecy Genevois
Pringy,
FranceSite Not Available
Ch Perigueux
Périgueux,
FranceSite Not Available
Chu Pontchaillou_Rennes
Rennes, 35033
FranceSite Not Available
Ch de Roubaix - Hopital Victor Provo
Roubaix,
FranceSite Not Available
Centre Henri Becquerel
Rouen, 76038
FranceSite Not Available
Service Hématologie, Institut Curie - Hôpital René HUGUENIN
Saint-Cloud, 92210
FranceSite Not Available
Chu de La Reunion - Hopital Felix Guyon
Saint-Denis,
FranceSite Not Available
Chu de La Reunion - Ghsr
Saint-Pierre,
FranceSite Not Available
Institut Cancerologie & Hematologie St-Etienne
Saint-Priest-en-Jarez, 42270
FranceSite Not Available
Ch de Saint-Quentin
Saint-Quentin,
FranceSite Not Available
Hôpitaux Universitaires de Strasbourg
Strasbourg,
FranceSite Not Available
Institut Universitaire du Cancer
Toulouse,
FranceSite Not Available
Chu Bretonneau
Tours,
FranceSite Not Available
Ch de Valence
Valence,
FranceSite Not Available
Ch de Valenciennes - Hopital Jean Bernard
Valenciennes,
FranceSite Not Available
Chu Brabois
Vandœuvre-lès-Nancy, 54511
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94805
FranceSite Not Available
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