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

• ClinicalTrials.gov Identifier: NCT00882011
• Recruitment Status: Unknown
• First Posted: April 16, 2009
• Last Update Posted: October 13, 2011
• Sponsor: Fondazione Italiana Linfomi ONLUS
• Information provided by (Responsible Party): Fondazione Italiana Linfomi ONLUS

Study Description

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).

Condition or disease	Intervention/treatment
Lymphoblastic Lymphoma	Other: Latest generation chemotherapies for T-LBL + transplant

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 Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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 Start Date: April 2009
• Estimated Primary Completion Date: April 2014
• Estimated Study Completion Date: April 2019

Groups and Cohorts

Group/Cohort

Intervention/treatment

Arm 1; Adult patients with T-lymphoblastic lymphoma treated with intensive chemo/radiotherapy or intensive chemotherapy followed by transplant.

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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. To evaluate if PET has a prognostic value in T-Lymphoblastic Lymphoma cases. [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA

Involved lymph nodes biopsy; biopsies performed in other areas affected by lymphoma; bone marrow blood; peripheral blood.

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Adult patients with T-lymphoblastic lymphoma treated with intensive chemo/radiotherapy or intensive chemotherapy followed by transplant.

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.

Contacts and Locations

Contacts

Contact: Sonia Perticone, PhD; +390131206071; segreteria@filinf.it

Locations

Italy

Ospedale dell'Angelo; Not yet recruiting

Mestre, VE, Italy

Principal Investigator: Teodoro Chisesi, MD

Casa Sollievo della Sofferenza; Not yet recruiting

Foggia, Italy

Principal Investigator: Nicola Cascavilla, MD

Ospedale San Martino; Recruiting

Genova, Italy

Principal Investigator: Michele Carella, MD

Ospedale Vito Fazzi; Not yet recruiting

Lecce, Italy

Principal Investigator: Nicola Di Renzo, MD

Azienda Ospedaliera Papardo; Recruiting

Messina, Italy

Principal Investigator: Maura Brugiatelli, MD

Università degli studi di Modena; Recruiting

Modena, Italy

Principal Investigator: Massimo Federico, MD

Policlinico San Matteo; Recruiting

Pavia, Italy

Principal Investigator: Ercole Brusamolino

Ospedale Civile Santo Spirito; Recruiting

Pescara, Italy

Principal Investigator: Simona Falorio, MD

Ospedale San Carlo; Not yet recruiting

Potenza, Italy

Principal Investigator: Attilio Olivieri, MD

Ospedale Bianche Melacrino Morelli; Not yet recruiting

Reggio Calabria, Italy

Principal Investigator: Caterina Stelitano, MD

Ospedale Sant'Eugenio; Recruiting

Roma, Italy

Principal Investigator: Elisabetta Abruzzese, MD

Università La Sapienza; Recruiting

Roma, Italy

Principal Investigator: Maurizio Martelli, MD

Azienda Ospedaliera Sassari; Recruiting

Sassari, Italy

Principal Investigator: Maurizio Longinotti, MD

Ospedale San Giovanni Battista Molinette; Not yet recruiting

Torino, Italy

Principal Investigator: Umberto Vitolo, MD

Ospedale San Giovanni Battista Molinette; Recruiting

Torino, Italy

Principal Investigator: Umberto Vitolo, MD

San Giovanni Battista Molinette - Biologia Molecolare; Not yet recruiting

Torino, Italy

Principal Investigator: Marco Ladetto, MD

Policlinico GB Rossi; Not yet recruiting

Verona, Italy

Principal Investigator: Giovanni Pizzolo, PhD

Sponsors and Collaborators

Fondazione Italiana Linfomi ONLUS

Investigators

• Study Director: Massimo Federico, MD; Azienda Ospedaliero-Universitaria di Modena (MO)

More Information

• Responsible Party: Fondazione Italiana Linfomi ONLUS
• ClinicalTrials.gov Identifier: NCT00882011
• Other Study ID Numbers: IIL-LY_01
• First Posted: April 16, 2009
• Last Update Posted: October 13, 2011
• Last Verified: October 2011

Keywords provided by Fondazione Italiana Linfomi ONLUS:

T-lymphoblastic lymphoma; Intensive chemo/radiotherapy; Intensive chemotherapy; Transplant; Adult patients

Additional relevant MeSH terms:

Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia