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Transplantation After Complete Response In Patients With T-cell Lymphoma (TRANSCRIPT)

Primary Purpose

Peripheral T Cell Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Chemotherapy + follow up
Chemotherapy + ASCT + follow up
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Peripheral T Cell Lymphoma focused on measuring peripheral T-cell Lymphoma, autologous stem cell transplantation, chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

  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

Sites / Locations

  • Chu D'Amiens - Hopital Sud
  • Chu D'Angers
  • Ch Victor Dupouy
  • Ch D'Avignon - Hopital Henri Duffaut
  • Ch de La Cote Basque
  • Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine
  • Ch Metropole Savoie - Site Chambery
  • Chu Estaing
  • Ch Alpes Leman
  • Hopital Henri Mondor
  • René Olivier Casasnovas
  • CHU Francois MITTERRAND
  • Ch de Dunkerque
  • Chd de Vendee
  • Ch de Versailles - Hopital Andre Mignot
  • CHU du Mans
  • Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL
  • Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,
  • Centre Leon Berard
  • Chu de Montpellier
  • Chu de Nantes
  • Centre Antoine Lacassagne
  • Chu de Nimes - Hopital Caremeau
  • Chr Orleans
  • Hopital Cochin
  • Hopital de La Pitie Salpetriere
  • Hopital Necker
  • Hopital Saint Antoine
  • Ch de Perpignan
  • Chu de Bordeaux - Hopital Haut-Leveque
  • Chu Lyon-SudRecruiting
  • Ch Annecy Genevois
  • Ch Perigueux
  • Chu Pontchaillou_Rennes
  • Ch de Roubaix - Hopital Victor Provo
  • Centre Henri Becquerel
  • Service Hématologie, Institut Curie - Hôpital René HUGUENIN
  • Chu de La Reunion - Hopital Felix Guyon
  • Chu de La Reunion - Ghsr
  • Institut Cancerologie & Hematologie St-Etienne
  • Ch de Saint-Quentin
  • Hôpitaux Universitaires de Strasbourg
  • Institut Universitaire du Cancer
  • Chu Bretonneau
  • Ch de Valence
  • Ch de Valenciennes - Hopital Jean Bernard
  • Chu Brabois
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Chemotherapy

Chemotherapy + ASCT

Arm Description

The 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 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of Overall survival (OS)
Overall survival will be measured from the date of randomization to the date of death from any cause
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of Overall response rate (ORR) and Complete Response Rate (CRR)
Overall Response Rate is defined as the proportion of subjects achieving best overall response of partial metabolic response (PMR) or complete metabolic response (CMR) at the end of ASCT (8-12 weeks after PIE). Assessment of response will be determined by investigator and based on Lugano Response Criteria 2014 (PET-CT-Based Response for FDG-avid lymphomas or CT-Based Response if not).
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of duration of Response (DoR)
Duration of response will be measured from the time of attainment of CMR or PMR to the date of first documented disease progression, relapse (based on investigator disease assessment), death from 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.
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of time to next Treatment (TTNT)
TTNT will be measured from the date of randomization to the date of first documented administration of new anti-lymphoma treatment.
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of quality of Life
The EuroQol 5 Dimensions questionnaire (EQ5D-5L) will be administered at baseline and every three months during follow-up visit.
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of cost-Effectiveness Analysis
Will be expressed as the extra cost per a quality adjusted life year. To assess the mean cost per patient of each group, the number of resources consumed and the amounts refunded will be extracted from the French National Health Insurance Information System. The number of QALYs in each group of the trial will be assessed with survival time and the validated EuroQol 5 Dimensions questionnaire (EQ5D-5L).
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of budget Impact Analysis
budget impact analysis to assess the potential annual economic impact of the new management recommendation (with or without ASCL) for the French Public Health Insurance System across a 3-year time period.
Adjusted comparison of chemotherapy regimens (CHOP vs CHOEP) in non-sALCL in terms of Overall Response Rate (ORR)
Overall Response Rate is defined as the proportion of subjects achieving best overall response of partial metabolic response (PMR) at the end of induction. Assessment of response will be determined by investigator and based on Lugano Response Criteria 2014 (PET-CT-Based Response for FDG-avid lymphomas or CT-Based Response if not).
Adjusted comparison of chemotherapy regimens (CHOP vs CHOEP) in non-sALCL in terms of Complete Response rate (CRR)
complete metabolic response is defined as the proportion of subjects achieving complete metabolic response (CMR) at the end of induction. Assessment of response will be determined by investigator and based on Lugano Response Criteria 2014 (PET-CT-Based Response for FDG-avid lymphomas or CT-Based Response if not).
To evaluate the predictive value of total metabolic tumor volume (TMTV) on PET-CT
Predictive value of TMTV on PET-CT
To Evaluate PET-CT Omics
PET-Omics
The assessment of the early PET-CT predictive value after four cycles of chemotherapy on treatment response according to the IWC (International Workshop Criteria) Lugano 2014
Predictive value of an early PET_CT after 4 cycles of chemotherapy on treatment response according to the IWC Lugano 2014

Full Information

First Posted
June 8, 2022
Last Updated
September 26, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05444712
Brief Title
Transplantation After Complete Response In Patients With T-cell Lymphoma
Acronym
TRANSCRIPT
Official Title
Transplantation After Complete Response In Patients With T-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
April 1, 2028 (Anticipated)
Study Completion Date
April 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T Cell Lymphoma
Keywords
peripheral T-cell Lymphoma, autologous stem cell transplantation, chemotherapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
The 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)
Arm Title
Chemotherapy + ASCT
Arm Type
Active Comparator
Arm Description
Chemotherapy 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
Intervention Type
Procedure
Intervention Name(s)
Chemotherapy + follow up
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Chemotherapy + ASCT + follow up
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of Overall survival (OS)
Description
Overall survival will be measured from the date of randomization to the date of death from any cause
Time Frame
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
Title
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of Overall response rate (ORR) and Complete Response Rate (CRR)
Description
Overall Response Rate is defined as the proportion of subjects achieving best overall response of partial metabolic response (PMR) or complete metabolic response (CMR) at the end of ASCT (8-12 weeks after PIE). Assessment of response will be determined by investigator and based on Lugano Response Criteria 2014 (PET-CT-Based Response for FDG-avid lymphomas or CT-Based Response if not).
Time Frame
At the end of ASCT (8-12 weeks after post-induction evaluation)
Title
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of duration of Response (DoR)
Description
Duration of response will be measured from the time of attainment of CMR or PMR to the date of first documented disease progression, relapse (based on investigator disease assessment), death from 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.
Time Frame
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
Title
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of time to next Treatment (TTNT)
Description
TTNT will be measured from the date of randomization to the date of first documented administration of new anti-lymphoma treatment.
Time Frame
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
Title
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of quality of Life
Description
The EuroQol 5 Dimensions questionnaire (EQ5D-5L) will be administered at baseline and every three months during follow-up visit.
Time Frame
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
Title
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of cost-Effectiveness Analysis
Description
Will be expressed as the extra cost per a quality adjusted life year. To assess the mean cost per patient of each group, the number of resources consumed and the amounts refunded will be extracted from the French National Health Insurance Information System. The number of QALYs in each group of the trial will be assessed with survival time and the validated EuroQol 5 Dimensions questionnaire (EQ5D-5L).
Time Frame
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
Title
Comparison of chemotherapy regimens + ASCT consolidation with chemotherapy regimens alone in terms of budget Impact Analysis
Description
budget impact analysis to assess the potential annual economic impact of the new management recommendation (with or without ASCL) for the French Public Health Insurance System across a 3-year time period.
Time Frame
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
Title
Adjusted comparison of chemotherapy regimens (CHOP vs CHOEP) in non-sALCL in terms of Overall Response Rate (ORR)
Description
Overall Response Rate is defined as the proportion of subjects achieving best overall response of partial metabolic response (PMR) at the end of induction. Assessment of response will be determined by investigator and based on Lugano Response Criteria 2014 (PET-CT-Based Response for FDG-avid lymphomas or CT-Based Response if not).
Time Frame
at the end of induction (between 3 and 5 weeks after the last drug administration)
Title
Adjusted comparison of chemotherapy regimens (CHOP vs CHOEP) in non-sALCL in terms of Complete Response rate (CRR)
Description
complete metabolic response is defined as the proportion of subjects achieving complete metabolic response (CMR) at the end of induction. Assessment of response will be determined by investigator and based on Lugano Response Criteria 2014 (PET-CT-Based Response for FDG-avid lymphomas or CT-Based Response if not).
Time Frame
at the end of induction (between 3 and 5 weeks after the last drug administration)
Title
To evaluate the predictive value of total metabolic tumor volume (TMTV) on PET-CT
Description
Predictive value of TMTV on PET-CT
Time Frame
at patient enrollment
Title
To Evaluate PET-CT Omics
Description
PET-Omics
Time Frame
at patient enrollment
Title
The assessment of the early PET-CT predictive value after four cycles of chemotherapy on treatment response according to the IWC (International Workshop Criteria) Lugano 2014
Description
Predictive value of an early PET_CT after 4 cycles of chemotherapy on treatment response according to the IWC Lugano 2014
Time Frame
After four cycles of chemotherapy (each cycle is 3weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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 Exclusion Criteria: 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 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: 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 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). 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-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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel BACHY, Pr
Phone
+33(0) 4 78 86 22 05
Email
emmanuel.bachy@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Rémy GRESSIN, Dr
Phone
+33 (0)4 76 76 57 12
Email
rgressin@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel BACHY, Pr
Organizational Affiliation
HCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu D'Amiens - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline DELETTE, MD
Email
Delette.caroline@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Caroline DELETTE
Facility Name
Chu D'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aline CLAVERT, MD
Email
Aline.clavert@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Aline CLAVERT
Facility Name
Ch Victor Dupouy
City
Argenteuil
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad AL JIJAKLI, MD
Email
Ahmad.aljijakli@ch-argenteuil.fr
First Name & Middle Initial & Last Name & Degree
Ahmad AL JIJAKLI
Facility Name
Ch D'Avignon - Hopital Henri Duffaut
City
Avignon
ZIP/Postal Code
84000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hacène ZERAZHI
Email
hzerazhi@ch-avignon.fr
First Name & Middle Initial & Last Name & Degree
Hacène ZERAZHI, MD
Facility Name
Ch de La Cote Basque
City
Bayonne
ZIP/Postal Code
64109
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie BERNARD, MD
Email
Sophie.s.bernard@gmail.com
First Name & Middle Initial & Last Name & Degree
Sophie BERNARD
Facility Name
Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier FITOUSSI, MD
Phone
+33 (0) 5 56 43 73 54
Email
o.fitoussi@bordeauxnord.com
First Name & Middle Initial & Last Name & Degree
Olivier FITOUSSI
Facility Name
Ch Metropole Savoie - Site Chambery
City
Chambéry
ZIP/Postal Code
73000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur DONY
Email
Arthur.dony@ch-metropole-savoie.fr
First Name & Middle Initial & Last Name & Degree
Arthur DONY
Facility Name
Chu Estaing
City
Clermont-Ferrand
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier TOURNILHAC, MD
Email
otournilhac@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Olivier TOURNILHAC
Facility Name
Ch Alpes Leman
City
Contamine sur Arve
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blandine BOUTIN
Email
bboutin@ch-alpes-leman.fr
First Name & Middle Initial & Last Name & Degree
Blandine BOUTIN
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François LEMONNIER, MD
First Name & Middle Initial & Last Name & Degree
François LEMONNIER
Facility Name
René Olivier Casasnovas
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Morschhauser, MD
Phone
33 3 20 44 42 90
Email
f-morschhauser@chu-lille.fr
First Name & Middle Initial & Last Name & Degree
Franck Morschhauser
Facility Name
CHU Francois MITTERRAND
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
René-Olivier CASASNOVAS, MD
Phone
03 80 29 50 41
Email
olivier.casasnovas@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
René-Olivier CASASNOVAS, MD
Facility Name
Ch de Dunkerque
City
Dunkerque
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah BARBIEUX, MD
Email
Sarah.barbieux@ch-dunkerque.Fr
First Name & Middle Initial & Last Name & Degree
Sarah BARBIEUX
Facility Name
Chd de Vendee
City
La Roche-sur-Yon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane VIGOUROUX, MD
Email
Stephane.vigourous@ght85.frf
First Name & Middle Initial & Last Name & Degree
Stéphane VIGOUROUX
Facility Name
Ch de Versailles - Hopital Andre Mignot
City
Le Chesnay
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena KOHN, MD
Email
mikohn@ch-versailles.fr
First Name & Middle Initial & Last Name & Degree
Milena KOHN
Facility Name
CHU du Mans
City
Le Mans
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamel LARIBI, MD
Email
klaribi@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Kamel LARIBI
Facility Name
Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy AMORIM, MD
Phone
+33 (0)3 20 87 45 32
Email
amorim.sandy@ghicl.net
First Name & Middle Initial & Last Name & Degree
Sandy AMORIM
Facility Name
Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie ABRAHAM, MD
Phone
+33 (0)5 55 05 66 51
Email
julie.abraham@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Julie ABRAHAM
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann GUILLERMIN
Email
Yann.guillermin@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Yann GUILLERMIN
Facility Name
Chu de Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles HERBAUX, Md
Email
c-herbaux@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Charles HERBAUX
Facility Name
Chu de Nantes
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit TESSOULIN, Md
Email
Benoit.tessoulin@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Benoit TESSOULIN
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric PEYRADE, MD
Email
Frederic.peyrade@nice.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Frédéric PEYRADE
Facility Name
Chu de Nimes - Hopital Caremeau
City
Nîmes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agathe WAULTIER - RASCALOU, MD
Email
Agathe.waultier.rascalou@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Agathe WAULTIER - RASCALOU
Facility Name
Chr Orleans
City
Orléans
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlène OCHMANN, MD
Email
Marlene.ochmann@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Marlène OCHMANN
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bénédicte DEAU-FISCHER
Email
Benedicte.deau@aphp.fr
First Name & Middle Initial & Last Name & Degree
Bénédicte DEAU-FISCHER
Facility Name
Hopital de La Pitie Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain CHOQUET, MD
Email
sylvain.choquet@aphp.fr
First Name & Middle Initial & Last Name & Degree
Sylvain CHOQUET
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75743
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ambroise MARCAIS, MD
Email
Ambroise.marcais@aphp.fr
First Name & Middle Initial & Last Name & Degree
Ambroise MARCAIS
Facility Name
Hopital Saint Antoine
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad MOHTY, MD
Email
Mohamad.mohty@inserm.fr
First Name & Middle Initial & Last Name & Degree
Mohamad MOHTY
Facility Name
Ch de Perpignan
City
Perpignan
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara BURCHERI, MD
Email
Sara.burcheri@ch-perpignan.Fr
First Name & Middle Initial & Last Name & Degree
Sara BURCHERI
Facility Name
Chu de Bordeaux - Hopital Haut-Leveque
City
Pessac
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François-Xavier GROS, MD
Email
Francois-xavier.gros@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
François-Xavier GROS
Facility Name
Chu Lyon-Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel BACHY, MD
Email
Emmanuel.bachy@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Emmanuel BACHY
Facility Name
Ch Annecy Genevois
City
Pringy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas DAGUINDAU, MD
Email
ndaguindau@ch-annecygenevois.fr
First Name & Middle Initial & Last Name & Degree
Nicolas DAGUINDAU
Facility Name
Ch Perigueux
City
Périgueux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire CALMETTES, MD
Email
Claire.calmettes@ch-perigueux.fr
First Name & Middle Initial & Last Name & Degree
Claire CALMETTES
Facility Name
Chu Pontchaillou_Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roch HOUOT, MD
Email
Roch.houot@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Roch HOUOT
Facility Name
Ch de Roubaix - Hopital Victor Provo
City
Roubaix
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia HIEULLE, MD
Email
Julia.hieulle@ch-roubaix.fr
First Name & Middle Initial & Last Name & Degree
Julia HIEULLE
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent CAMUS, MD
Email
Vincent.camus@chb.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Vincent CAMUS
Facility Name
Service Hématologie, Institut Curie - Hôpital René HUGUENIN
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole SOUSSAIN, MD
Phone
+33 (0)1 47 11 15 15
Email
carole.soussain@curie.fr
Facility Name
Chu de La Reunion - Hopital Felix Guyon
City
Saint-Denis
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie DE CHARRETTE, MD
Email
marie.de-charette@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Marie DE CHARRETTE
Facility Name
Chu de La Reunion - Ghsr
City
Saint-Pierre
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo LEGENDRE, MD
Email
Hugo.legendre@chu-reunion.Fr
First Name & Middle Initial & Last Name & Degree
Hugo LEGENDRE
Facility Name
Institut Cancerologie & Hematologie St-Etienne
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme CORNILLON, MD
Email
Jerome.cornillon@icloire.fr
First Name & Middle Initial & Last Name & Degree
Jérôme CORNILLON
Facility Name
Ch de Saint-Quentin
City
Saint-Quentin
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Réda GARIDI, Md
Email
r.garidi@ch-stquentin.fr
First Name & Middle Initial & Last Name & Degree
Réda GARIDI
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc-Matthieu FORNECKER, MD
Phone
03 88 12 76 79
Ext
+33
Email
luc-matthieu.fornecker@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Luc-Matthieu FORNECKER, MD
Facility Name
Institut Universitaire du Cancer
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loïc YSEBAERT, MD
Phone
05 31 15 63 51
Ext
+33
Email
ysebaert.loic@iuct-oncopole.fr
First Name & Middle Initial & Last Name & Degree
Loïc YSEBAERT, MD
Facility Name
Chu Bretonneau
City
Tours
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurianne DRIEU LA ROCHELLE, MD
Email
l.drieu-la-rochelle@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Laurianne DRIEU LA ROCHELLE
Facility Name
Ch de Valence
City
Valence
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clémence SANTANA, MD
Email
Clemence.santana@ch-valence.fr
First Name & Middle Initial & Last Name & Degree
Clémence SANTANA
Facility Name
Ch de Valenciennes - Hopital Jean Bernard
City
Valenciennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine TRICOT, MD
Email
tricot-s@ch-valenciennes.Fr
First Name & Middle Initial & Last Name & Degree
Sabine TRICOT
Facility Name
Chu Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charline MOULIN, MD
Email
c.moulin@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Charline MOULIN
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent RIBRAG, MD
Email
Vincent.ribrag@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Vincent RIBRAG

12. IPD Sharing Statement

Learn more about this trial

Transplantation After Complete Response In Patients With T-cell Lymphoma

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