Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoblastic Lymphoma
Keywords: T-lymphoblastic lymphoma
Intensive chemo/radiotherapy
Intensive chemotherapy
Transplant
Adult patients
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with T-lymphoblastic lymphoma treated with intensive chemo/radiotherapy or intensive chemotherapy followed by transplant.

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.

Eligibility 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.

Primary outcomes:
measure: To create a prospective database of T-lymphoblastic lymphoma cases on adult patients in order to conduct an appropriate statistical study.
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
measure: To make a gene expression analysis on T-Lymphoblastic Lymphoma patients to detect specific genetic profiles useful to give prognostic and therapy response advices.
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
measure: To evaluate if PET has a prognostic value in T-Lymphoblastic Lymphoma cases.
timeFrame: 5 years
Other outcomes:
Locations:
city: Mestre
country: Italy
facility: Ospedale dell'Angelo
state: VE
city: Foggia
country: Italy
facility: Casa Sollievo della Sofferenza
city: Genova
country: Italy
facility: Ospedale San Martino
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Messina
country: Italy
facility: Azienda Ospedaliera Papardo
city: Modena
country: Italy
facility: Università degli studi di Modena
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Pescara
country: Italy
facility: Ospedale Civile Santo Spirito
city: Potenza
country: Italy
facility: Ospedale San Carlo
city: Reggio Calabria
country: Italy
facility: Ospedale Bianche Melacrino Morelli
city: Roma
country: Italy
facility: Ospedale Sant'Eugenio
city: Roma
country: Italy
facility: Università La Sapienza
city: Sassari
country: Italy
facility: Azienda Ospedaliera Sassari
city: Torino
country: Italy
facility: Ospedale San Giovanni Battista Molinette
city: Torino
country: Italy
facility: Ospedale San Giovanni Battista Molinette
city: Torino
country: Italy
facility: San Giovanni Battista Molinette - Biologia Molecolare
city: Verona
country: Italy
facility: Policlinico GB Rossi
Study officials:
affiliation: Azienda Ospedaliero-Universitaria di Modena (MO)
name: Massimo Federico, MD
role: STUDY_DIRECTOR
References: