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

Fondazione Italiana Linfomi - ETS

Status

Unknown

Conditions

Lymphoblastic Lymphoma

Treatments

Other: Latest generation chemotherapies for T-LBL + transplant

Study type

Observational

Funder types

Other

Identifiers

NCT00882011

IIL-LY_01

Details and patient eligibility

About

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 residual disease (MRD), to detect specific genetic profile useful to give advices on therapies, to assess if PET has a prognostic validity on T-Lymphoblastic Lymphoma (T-LBL).

Full 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 (hyper-CVAD or Stanford), autologous or allogeneic transplant or reduced intensity conditioning allotransplant after induction/consolidation and also expected cases treated with high dose sequential therapy or intensified minimal residual disease (MRD) oriented therapy;
enter classic T-LBL patients (bone marrow infiltrate <25%) treated as long as previous section;
monitor therapy response/phenotype ratio by the study of phenotype;
monitor therapy response/residual disease/patients outcome ratio by the study of T-cell receptor gene rearrangement;
evaluate any gene-profile difference between T-LBL pre-thymic phenotype and T-LBL thymic phenotype so as to correlate it to outcome;
monitor the stage of the disease at diagnosis, during the therapy and during the follow-up by means of TAC, so to value if PET (in association with TAC) is an additional and/or outcome predicting element compared to TAC.

Enrollment

100 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.