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

NCT00882011 | Unknown

• 1 other identifier: IIL-LY_01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 17

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).

Conditions

Lymphoblastic Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To create a prospective database of T-lymphoblastic lymphoma cases on adult patients in order to conduct an appropriate statistical study.

  5 years

Secondary Outcomes (4)

• 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

• 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 evaluate if PET has a prognostic value in T-Lymphoblastic Lymphoma cases.

  5 years

Study Arms (1)

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

Interventions

Latest generation chemotherapies for T-LBL + transplant OTHER

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

Arm 1

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• patients with previous HCV, HBsAg+ or suffering from HIV;
• patients with organic pathology not related to lymphoma.

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (17)

Ospedale dell'Angelo

Mestre, VE, Italy

NOT YET RECRUITING

Casa Sollievo della Sofferenza

Foggia, Italy

NOT YET RECRUITING

Ospedale San Martino

Genova, Italy

RECRUITING

Ospedale Vito Fazzi

Lecce, Italy

NOT YET RECRUITING

Azienda Ospedaliera Papardo

Messina, Italy

RECRUITING

Università degli studi di Modena

Modena, Italy

RECRUITING

Policlinico San Matteo

Pavia, Italy

RECRUITING

Ospedale Civile Santo Spirito

Pescara, Italy

RECRUITING

Ospedale San Carlo

Potenza, Italy

NOT YET RECRUITING

Ospedale Bianche Melacrino Morelli

Reggio Calabria, Italy

NOT YET RECRUITING

Ospedale Sant'Eugenio

Roma, Italy

RECRUITING

Università La Sapienza

Roma, Italy

RECRUITING

Azienda Ospedaliera Sassari

Sassari, Italy

RECRUITING

Ospedale San Giovanni Battista Molinette

Torino, Italy

NOT YET RECRUITING

Ospedale San Giovanni Battista Molinette

Torino, Italy

RECRUITING

San Giovanni Battista Molinette - Biologia Molecolare

Torino, Italy

NOT YET RECRUITING

Policlinico GB Rossi

Verona, Italy

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Massimo Federico, MD

  Azienda Ospedaliero-Universitaria di Modena (MO)

  STUDY DIRECTOR

Central Study Contacts

Sonia Perticone, PhD

CONTACT

+390131206071; segreteria@filinf.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2019
• Last Updated: October 13, 2011

Record last verified: 2011-10

Locations

IT (17)