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
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.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
To create a prospective database of T-lymphoblastic lymphoma cases on adult patients in order to conduct an appropriate statistical study.
5 years
No
Massimo Federico, MD
Study Director
Azienda Ospedaliero-Universitaria di Modena (MO)
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
IIL-LY_01
NCT00882011
April 2009
April 2019
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