Transplantation After Complete Response In Patients With T-cell Lymphoma

Last updated: September 26, 2023
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-hodgkin's Lymphoma

Lymphoma

Treatment

Chemotherapy + follow up

Chemotherapy + ASCT + follow up

Clinical Study ID

NCT05444712
69HCL21_1095
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Patient ≥ 18 years and < 70 years of age at the time of signing the informed consentform (ICF)
  2. Patient fit enough to receive autologous stem cell transplant as a consolidationstrategy as assessed by the local investigator
  3. 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
  1. Ann Arbor staging (I-IV) except stage I with normal LDH and PS<2 (i.e. stage I aaIPI
  1. 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)
  2. FFPE Diagnostic tissue block should be available for central pathology review andancillary molecular analyses
  3. Participant with Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  4. Estimated minimum life expectancy of 3 months
  5. Patient who understood and voluntarily signed and dated an informed consent prior toany study-specific assessments/procedures being conducted
  6. Able to adhere to the study visit schedule and other protocol requirements
  7. Patient covered by any social security system (France)
  8. Patient who understands and speaks one of the country official languages
  9. 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
  10. 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:

  1. Known central nervous system or meningeal involvement by lymphoma
  2. 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.
  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
  1. 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:
  2. Basal or squamous cell carcinoma of the skin
  3. Carcinoma in situ of the cervix
  4. Carcinoma in situ of the breast
  5. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor,nodes, metastasis clinical staging system
  6. Vaccinated with live, attenuated vaccines within 6 months of enrollment
  7. 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).
  8. A corticosteroids therapy > 1mg/kg lasting more than 14 days prior to Cycle 1 Day 1
  9. Positive serology for Human Immunodeficiency Virus (HIV) and Human T-LymphotrophicVirus (HTLV1)
  10. 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

Total Participants: 204
Treatment Group(s): 2
Primary Treatment: Chemotherapy + follow up
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
April 01, 2028

Connect with a study center

  • Chu D'Amiens - Hopital Sud

    Amiens, 80054
    France

    Site Not Available

  • Chu D'Angers

    Angers, 49933
    France

    Site Not Available

  • Ch Victor Dupouy

    Argenteuil,
    France

    Site Not Available

  • Ch D'Avignon - Hopital Henri Duffaut

    Avignon, 84000
    France

    Site Not Available

  • Ch de La Cote Basque

    Bayonne, 64109
    France

    Site Not Available

  • Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300
    France

    Site Not Available

  • Ch Metropole Savoie - Site Chambery

    Chambéry, 73000
    France

    Site Not Available

  • Chu Estaing

    Clermont-Ferrand,
    France

    Site Not Available

  • Ch Alpes Leman

    Contamine sur Arve,
    France

    Site Not Available

  • Hopital Henri Mondor

    Creteil, 94010
    France

    Site Not Available

  • CHU Francois MITTERRAND

    Dijon,
    France

    Site Not Available

  • René Olivier Casasnovas

    Dijon, 21000
    France

    Site Not Available

  • Ch de Dunkerque

    Dunkerque,
    France

    Site Not Available

  • Chd de Vendee

    La Roche-sur-Yon,
    France

    Site Not Available

  • Ch de Versailles - Hopital Andre Mignot

    Le Chesnay,
    France

    Site Not Available

  • CHU du Mans

    Le Mans,
    France

    Site Not Available

  • Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL

    Lille, 59020
    France

    Site Not Available

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

    Limoges, 87042
    France

    Site Not Available

  • Centre Leon Berard

    Lyon, 69373
    France

    Site Not Available

  • Chu de Montpellier

    Montpellier,
    France

    Site Not Available

  • Chu de Nantes

    Nantes,
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Site Not Available

  • Chu de Nimes - Hopital Caremeau

    Nîmes,
    France

    Site Not Available

  • Chr Orleans

    Orléans,
    France

    Site Not Available

  • Hopital Cochin

    Paris, 75014
    France

    Site Not Available

  • Hopital Necker

    Paris, 75743
    France

    Site Not Available

  • Hopital Saint Antoine

    Paris,
    France

    Site Not Available

  • Hopital de La Pitie Salpetriere

    Paris, 75651
    France

    Site Not Available

  • Ch de Perpignan

    Perpignan,
    France

    Site Not Available

  • Chu de Bordeaux - Hopital Haut-Leveque

    Pessac,
    France

    Site Not Available

  • Chu Lyon-Sud

    Pierre Benite, 69495
    France

    Active - Recruiting

  • Ch Annecy Genevois

    Pringy,
    France

    Site Not Available

  • Ch Perigueux

    Périgueux,
    France

    Site Not Available

  • Chu Pontchaillou_Rennes

    Rennes, 35033
    France

    Site Not Available

  • Ch de Roubaix - Hopital Victor Provo

    Roubaix,
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen, 76038
    France

    Site Not Available

  • Service Hématologie, Institut Curie - Hôpital René HUGUENIN

    Saint-Cloud, 92210
    France

    Site Not Available

  • Chu de La Reunion - Hopital Felix Guyon

    Saint-Denis,
    France

    Site Not Available

  • Chu de La Reunion - Ghsr

    Saint-Pierre,
    France

    Site Not Available

  • Institut Cancerologie & Hematologie St-Etienne

    Saint-Priest-en-Jarez, 42270
    France

    Site Not Available

  • Ch de Saint-Quentin

    Saint-Quentin,
    France

    Site Not Available

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg,
    France

    Site Not Available

  • Institut Universitaire du Cancer

    Toulouse,
    France

    Site Not Available

  • Chu Bretonneau

    Tours,
    France

    Site Not Available

  • Ch de Valence

    Valence,
    France

    Site Not Available

  • Ch de Valenciennes - Hopital Jean Bernard

    Valenciennes,
    France

    Site Not Available

  • Chu Brabois

    Vandœuvre-lès-Nancy, 54511
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

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