Status:
UNKNOWN
Observational Controlled Clinical Trials, on Adult Patients With T-lymphoblastic Lymphoma Treated With Intensive Chemo/Radiotherapy or Intensive Chemotherapy Followed by Transplant. Evaluation of Clinical, Anatomy -Pathological Parameters
Lead Sponsor:
Fondazione Italiana Linfomi - ETS
Conditions:
Lymphoblastic Lymphoma
Eligibility:
All Genders
15+ years
Brief Summary
The purpose of the study is to create a prospective database of T-Lymphoblastic Lymphoma (T-LBL) cases in order to conduct an appropriate statistical study as well as to monitor diagnosis and minimal ...
Detailed Description
Observational prospective Clinical Trial designed to: * record all patients treated with a latest generation ALL-like therapy (e.g.: Holzer, LSA2-L2 modified, GIMEMA LAL094), an enhanced therapy (hyp...
Eligibility Criteria
Inclusion
- no previous therapy, except for treatments to face up to clinical presentation of emergency;
- medical history initially characterized by nodal mass/masses;
- histological and immunophenotypic diagnosis that documents the diagnosis of T-LBL; in cases of bone marrow involvement and difficulties in obtaining nodal material, diagnosis could be based on bone marrow;
- availability of biological material for the study of TCR and gene-profile;
- age ≥ 15 years;
- all stages;
- infiltrated bone marrow \<25%;
- normal liver, renal and cardiac functions, except for alterations directly related to lymphoma;
- estimates of treatment according to one of the last generation schedules;
- written informed consent.
Exclusion
- patients with previous HCV, HBsAg+ or suffering from HIV;
- patients with organic pathology not related to lymphoma.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00882011
Start Date
April 1 2009
End Date
April 1 2019
Last Update
October 13 2011
Active Locations (17)
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1
Ospedale dell'Angelo
Mestre, VE, Italy
2
Casa Sollievo della Sofferenza
Foggia, Italy
3
Ospedale San Martino
Genova, Italy
4
Ospedale Vito Fazzi
Lecce, Italy