Actively Recruiting
Transplantation After Complete Response In Patients With T-cell Lymphoma
Led by Hospices Civils de Lyon · Updated on 2023-09-28
204
Participants Needed
48
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transplantation After Complete Response In Patients With T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to less than 70 years at time of informed consent
- Fit enough to receive autologous stem cell transplant as assessed by local investigator
- Hemoglobin level above 8 g/dL (transfusions allowed)
- Neutrophil count above 0.5 G/L
- Platelet count above 50 G/L (transfusions allowed)
- Histologically confirmed nodal-type peripheral T-cell lymphoma including PTCL not otherwise specified, follicular helper T-cell lymphomas, and ALK-negative anaplastic large cell lymphoma
- Ann Arbor stage I to IV except stage I with normal LDH and performance status less than 2
- Measurable disease by Lugano criteria
- Availability of diagnostic tissue block for pathology review
- ECOG performance status between 0 and 2
- Estimated life expectancy of at least 3 months
- Voluntary signed informed consent
- Ability to follow study visit schedule and protocol requirements
- Covered by a social security system in France
- Understands and speaks an official language of the country
- Males with partners of childbearing potential must agree to use effective birth control
- Females of childbearing potential must agree to use effective birth control before, during, and after study as informed by investigator
You will not qualify if you...
- Central nervous system or meningeal involvement by lymphoma
- Impaired kidney function with creatinine clearance below 30 ml/min
- Liver function abnormalities with bilirubin above 2.0 mg/dl (except Gilbert's Syndrome or lymphoma involvement) or transaminases above three times normal unless lymphoma-related
- Certain T-cell lymphoma subtypes excluded, including adult T-cell leukemia/lymphoma, nasal type extranodal T-cell/NK-cell lymphoma, ALK-positive anaplastic large cell lymphoma, cutaneous T-cell lymphomas, primary cutaneous CD30+ disorders, enteropathy-associated T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, and primary cutaneous gamma-delta T-cell lymphoma
- Active malignancy other than study lymphoma, except some skin and cervical cancers if disease-free for 2+ years
- Vaccination with live attenuated vaccines within 6 months before enrollment
- Prior anti-cancer drug therapy except limited use of specific drugs
- Corticosteroid therapy above 1 mg/kg lasting more than 14 days before first treatment day
- Positive HIV or Human T-Lymphotrophic Virus serology
- Active hepatitis B or C infection
- Pregnant, planning pregnancy, or breastfeeding women of childbearing potential
- Significant medical, laboratory, or psychiatric conditions interfering with participation
- Persons deprived of liberty or hospitalized without consent
- Adults under legal protection
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 48 locations
1
Chu D'Amiens - Hopital Sud
Amiens, France, 80054
Not Yet Recruiting
2
Chu D'Angers
Angers, France, 49933
Not Yet Recruiting
3
Ch Victor Dupouy
Argenteuil, France
Not Yet Recruiting
4
Ch D'Avignon - Hopital Henri Duffaut
Avignon, France, 84000
Not Yet Recruiting
5
Ch de La Cote Basque
Bayonne, France, 64109
Not Yet Recruiting
6
Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
Not Yet Recruiting
7
Ch Metropole Savoie - Site Chambery
Chambéry, France, 73000
Not Yet Recruiting
8
Chu Estaing
Clermont-Ferrand, France
Not Yet Recruiting
9
Ch Alpes Leman
Contamine-sur-Arve, France
Not Yet Recruiting
10
Hopital Henri Mondor
Créteil, France, 94010
Not Yet Recruiting
11
René Olivier Casasnovas
Dijon, France, 21000
Not Yet Recruiting
12
CHU Francois MITTERRAND
Dijon, France
Not Yet Recruiting
13
Ch de Dunkerque
Dunkirk, France
Not Yet Recruiting
14
Chd de Vendee
La Roche-sur-Yon, France
Not Yet Recruiting
15
Ch de Versailles - Hopital Andre Mignot
Le Chesnay, France
Not Yet Recruiting
16
CHU du Mans
Le Mans, France
Not Yet Recruiting
17
Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL
Lille, France, 59020
Not Yet Recruiting
18
Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,
Limoges, France, 87042
Not Yet Recruiting
19
Centre Leon Berard
Lyon, France, 69373
Not Yet Recruiting
20
Chu de Montpellier
Montpellier, France
Not Yet Recruiting
21
Chu de Nantes
Nantes, France
Not Yet Recruiting
22
Centre Antoine Lacassagne
Nice, France, 06189
Not Yet Recruiting
23
Chu de Nimes - Hopital Caremeau
Nîmes, France
Not Yet Recruiting
24
Chr Orleans
Orléans, France
Not Yet Recruiting
25
Hopital Cochin
Paris, France, 75014
Not Yet Recruiting
26
Hopital de La Pitie Salpetriere
Paris, France, 75651
Not Yet Recruiting
27
Hopital Necker
Paris, France, 75743
Not Yet Recruiting
28
Hopital Saint Antoine
Paris, France
Not Yet Recruiting
29
Ch de Perpignan
Perpignan, France
Not Yet Recruiting
30
Chu de Bordeaux - Hopital Haut-Leveque
Pessac, France
Not Yet Recruiting
31
Ch Perigueux
Périgueux, France
Not Yet Recruiting
32
Chu Lyon-Sud
Pierre-Bénite, France, 69495
Actively Recruiting
33
Ch Annecy Genevois
Pringy, France
Not Yet Recruiting
34
Chu Pontchaillou_Rennes
Rennes, France, 35033
Not Yet Recruiting
35
Ch de Roubaix - Hopital Victor Provo
Roubaix, France
Not Yet Recruiting
36
Centre Henri Becquerel
Rouen, France, 76038
Not Yet Recruiting
37
Service Hématologie, Institut Curie - Hôpital René HUGUENIN
Saint-Cloud, France, 92210
Not Yet Recruiting
38
Chu de La Reunion - Hopital Felix Guyon
Saint-Denis, France
Not Yet Recruiting
39
Chu de La Reunion - Ghsr
Saint-Pierre, France
Not Yet Recruiting
40
Institut Cancerologie & Hematologie St-Etienne
Saint-Priest-en-Jarez, France, 42270
Not Yet Recruiting
41
Ch de Saint-Quentin
Saint-Quentin, France
Not Yet Recruiting
42
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Not Yet Recruiting
43
Institut Universitaire du Cancer
Toulouse, France
Not Yet Recruiting
44
Chu Bretonneau
Tours, France
Not Yet Recruiting
45
Ch de Valence
Valence, France
Not Yet Recruiting
46
Ch de Valenciennes - Hopital Jean Bernard
Valenciennes, France
Not Yet Recruiting
47
Chu Brabois
Vandœuvre-lès-Nancy, France, 54511
Not Yet Recruiting
48
Institut Gustave Roussy
Villejuif, France, 94805
Not Yet Recruiting
Research Team
E
Emmanuel BACHY, Pr
CONTACT
R
Rémy GRESSIN, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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