NCT00882011

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 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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoblastic Lymphoma

Interventions

Type	Name	Description
OTHER	Latest generation chemotherapies for T-LBL + transplant	1. Standard doses of one of the following chemotherapies: * Holzer * LSA2-L2 modified * Stanford regimen * Hyper CVAD * Sequential treatments analogous to the ones above mentioned (e.g.: GIMEMA LAL094, others) * Intensive chemotherapy, ALL-type, MRD oriented (NILG-TLL Clinical Trial) 2. Autologous transplant or allogeneic transplant or mini-allogeneic transplant

Timeline

• Start date: 2009-04-01
• Primary completion: 2014-04-01
• Completion: 2019-04-01
• First posted: 2009-04-16
• Last updated: 2011-10-13

Locations

17 sites across 1 country: Italy