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
• Interventions: Other: Latest generation chemotherapies for T-LBL + transplant

• Registration Number: NCT00882011
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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 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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-12
• Last Update Posted: 2011-10-13
• Primary Completion: 2014-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	Latest generation chemotherapies for T-LBL + transplant	Adult patients with T-lymphoblastic lymphoma treated with intensive chemo/radiotherapy or intensive chemotherapy followed by transplant.

Primary Outcome Measures

Name	Time	Method
To create a prospective database of T-lymphoblastic lymphoma cases on adult patients in order to conduct an appropriate statistical study.	5 years

Secondary Outcome Measures

Name	Time	Method
To evaluate if PET has a prognostic value in T-Lymphoblastic Lymphoma cases.	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.	5 years
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.	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.	5 years

Trial Locations

Locations (16)

Casa Sollievo della Sofferenza; 🇮🇹 Foggia, Italy

Azienda Ospedaliera Papardo; 🇮🇹 Messina, Italy

Policlinico San Matteo; 🇮🇹 Pavia, Italy

Ospedale San Martino; 🇮🇹 Genova, Italy

Policlinico GB Rossi; 🇮🇹 Verona, Italy

Ospedale Sant'Eugenio; 🇮🇹 Roma, Italy

Ospedale dell'Angelo; 🇮🇹 Mestre, VE, Italy

Ospedale Vito Fazzi; 🇮🇹 Lecce, Italy

Università degli studi di Modena; 🇮🇹 Modena, Italy

Ospedale Civile Santo Spirito; 🇮🇹 Pescara, Italy

Ospedale San Carlo; 🇮🇹 Potenza, Italy

Ospedale Bianche Melacrino Morelli; 🇮🇹 Reggio Calabria, Italy

Azienda Ospedaliera Sassari; 🇮🇹 Sassari, Italy

Università La Sapienza; 🇮🇹 Roma, Italy

Ospedale San Giovanni Battista Molinette; 🇮🇹 Torino, Italy

San Giovanni Battista Molinette - Biologia Molecolare; 🇮🇹 Torino, Italy