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

Lymphoblastic Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00882011
• Other study ID #: IIL-LY_01
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2009
• Last updated: October 12, 2011
• Start date: April 2009
• Est. completion date: April 2019

Study information

• Verified date: October 2011
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: Sonia Perticone, PhD
• Phone: +390131206071
• Email: segreteria[@]filinf.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2019
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoblastic Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Other:
• Latest generation chemotherapies for T-LBL + transplant
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) Autologous transplant or allogeneic transplant or mini-allogeneic transplant

Locations

Country	Name	City	State
Italy	Casa Sollievo della Sofferenza	Foggia
Italy	Ospedale San Martino	Genova
Italy	Ospedale Vito Fazzi	Lecce
Italy	Azienda Ospedaliera Papardo	Messina
Italy	Ospedale dell'Angelo	Mestre	VE
Italy	Università degli studi di Modena	Modena
Italy	Policlinico San Matteo	Pavia
Italy	Ospedale Civile Santo Spirito	Pescara
Italy	Ospedale San Carlo	Potenza
Italy	Ospedale Bianche Melacrino Morelli	Reggio Calabria
Italy	Ospedale Sant'Eugenio	Roma
Italy	Università La Sapienza	Roma
Italy	Azienda Ospedaliera Sassari	Sassari
Italy	Ospedale San Giovanni Battista Molinette	Torino
Italy	Ospedale San Giovanni Battista Molinette	Torino
Italy	San Giovanni Battista Molinette - Biologia Molecolare	Torino
Italy	Policlinico GB Rossi	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To create a prospective database of T-lymphoblastic lymphoma cases on adult patients in order to conduct an appropriate statistical study.		5 years	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	To evaluate if PET has a prognostic value in T-Lymphoblastic Lymphoma cases.		5 years	No