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

This study is currently recruiting participants.
Verified October 2011 by Fondazione Italiana Linfomi ONLUS
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT00882011
First received: April 15, 2009
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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 Intervention
Lymphoblastic Lymphoma
Other: Latest generation chemotherapies for T-LBL + transplant

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Fondazione Italiana Linfomi ONLUS:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate if PET has a prognostic value in T-Lymphoblastic Lymphoma cases. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
  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

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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882011

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         
Università La Sapienza Recruiting
Roma, Italy
Principal Investigator: Maurizio Martelli, MD         
Ospedale Sant'Eugenio Recruiting
Roma, Italy
Principal Investigator: Elisabetta Abruzzese, MD         
Azienda Ospedaliera Sassari Recruiting
Sassari, Italy
Principal Investigator: Maurizio Longinotti, MD         
San Giovanni Battista Molinette - Biologia Molecolare Not yet recruiting
Torino, Italy
Principal Investigator: Marco Ladetto, MD         
Ospedale San Giovanni Battista Molinette Recruiting
Torino, Italy
Principal Investigator: Umberto Vitolo, MD         
Ospedale San Giovanni Battista Molinette Not yet recruiting
Torino, Italy
Principal Investigator: Umberto Vitolo, 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

No publications provided

Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT00882011     History of Changes
Other Study ID Numbers: IIL-LY_01
Study First Received: April 15, 2009
Last Updated: October 12, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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

ClinicalTrials.gov processed this record on April 17, 2014