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
Conditions
Lymphoblastic Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Conditions: Keywords
T-lymphoblastic lymphoma, Intensive chemo/radiotherapy, Intensive chemotherapy, Transplant, Adult patients
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: Latest generation chemotherapies for T-LBL + transplant
Type: Other
Overall Status
Recruiting
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 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).
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 (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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 15 Years
Gender: Both
Criteria: 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.

Exclusion Criteria:

- patients with previous HCV, HBsAg+ or suffering from HIV;

- patients with organic pathology not related to lymphoma.
Locations
Ospedale dell'Angelo
Mestre, VE, Italy
Status: Not yet recruiting
Casa Sollievo della Sofferenza
Foggia, Italy
Status: Not yet recruiting
Ospedale San Martino
Genova, Italy
Status: Recruiting
Ospedale Vito Fazzi
Lecce, Italy
Status: Not yet recruiting
Azienda Ospedaliera Papardo
Messina, Italy
Status: Recruiting
Università degli studi di Modena
Modena, Italy
Status: Recruiting
Policlinico San Matteo
Pavia, Italy
Status: Recruiting
Ospedale Civile Santo Spirito
Pescara, Italy
Status: Recruiting
Ospedale San Carlo
Potenza, Italy
Status: Not yet recruiting
Ospedale Bianche Melacrino Morelli
Reggio Calabria, Italy
Status: Not yet recruiting
Ospedale Sant'Eugenio
Roma, Italy
Status: Recruiting
Università La Sapienza
Roma, Italy
Status: Recruiting
Azienda Ospedaliera Sassari
Sassari, Italy
Status: Recruiting
Ospedale San Giovanni Battista Molinette
Torino, Italy
Status: Not yet recruiting
Ospedale San Giovanni Battista Molinette
Torino, Italy
Status: Recruiting
San Giovanni Battista Molinette - Biologia Molecolare
Torino, Italy
Status: Not yet recruiting
Policlinico GB Rossi
Verona, Italy
Status: Not yet recruiting
Start Date
April 2009
Completion Date
April 2019
Sponsors
Fondazione Italiana Linfomi ONLUS
Source
Fondazione Italiana Linfomi ONLUS
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page