Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Observational Controlled Clinical Trials, on Adult Patients With T-lymphoblastic Lymphoma Treated With Intensive Chemo/Radiotherapy or Intensive Chemotherapy Followed by T

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 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 Summary:

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.

Sponsor: Fondazione Italiana Linfomi ONLUS

Current Primary Outcome: To create a prospective database of T-lymphoblastic lymphoma cases on adult patients in order to conduct an appropriate statistical study. [ Time Frame: 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To monitor histological and immunophenotypical diagnosis and to make a minimal residual disease (MRD) molecular study in order to verify if minimal residual disease (MRD) prognostic value observed in children is confirmed in adult patients. [ Time Frame: 5 years ]
  • To make a gene expression analysis on T-Lymphoblastic Lymphoma patients to detect specific genetic profiles useful to give prognostic and therapy response advices. [ Time Frame: 5 years ]
  • To validated the prognostic systems already identified in T-Acute Lymphoblastic Leukemia cases that can be useful to label the high-risk for Lymphoblastic Lymphoma patients. [ Time Frame: 5 years ]
  • To evaluate if PET has a prognostic value in T-Lymphoblastic Lymphoma cases. [ Time Frame: 5 years ]


Original Secondary Outcome:

  • To monitor histological and immunophenotypical diagnosis and to make a MRD molecular study in order to verify if MRD prognostic value observed in children is confirmed in adult patients. [ Time Frame: 5 years ]
  • To make a gene expression analysis on T-LBL patients to detect specific genetic profiles useful to give prognostic and therapy response advices. [ Time Frame: 5 years ]
  • To convalidate the prognostic systems already identified in T-ALL cases that can be useful to label the high-risk for LBL patients. [ Time Frame: 5 years ]
  • To evaluate if PET has a prognostic value in T-LBL cases. [ Time Frame: 5 years ]


Information By: Fondazione Italiana Linfomi ONLUS

Dates:
Date Received: April 15, 2009
Date Started: April 2009
Date Completion: April 2019
Last Updated: October 12, 2011
Last Verified: October 2011