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

October 12, 2011 updated by: Fondazione Italiana Linfomi ONLUS

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Foggia, Italy
        • Not yet recruiting
        • Casa Sollievo della Sofferenza
      • Genova, Italy
        • Recruiting
        • Ospedale San Martino
        • Principal Investigator:
          • Michele Carella, MD
      • Lecce, Italy
        • Not yet recruiting
        • Ospedale Vito Fazzi
      • Messina, Italy
        • Recruiting
        • Azienda Ospedaliera Papardo
      • Modena, Italy
        • Recruiting
        • Università degli Studi di Modena
      • Pavia, Italy
        • Recruiting
        • Policlinico San Matteo
        • Principal Investigator:
          • Ercole Brusamolino
      • Pescara, Italy
        • Recruiting
        • Ospedale Civile Santo Spirito
        • Principal Investigator:
          • Simona Falorio, MD
      • Potenza, Italy
        • Not yet recruiting
        • Ospedale San Carlo
      • Reggio Calabria, Italy
        • Not yet recruiting
        • Ospedale Bianche Melacrino Morelli
      • Roma, Italy
        • Recruiting
        • Ospedale Sant'Eugenio
      • Roma, Italy
        • Recruiting
        • Università La Sapienza
      • Sassari, Italy
        • Recruiting
        • Azienda Ospedaliera Sassari
      • Torino, Italy
        • Not yet recruiting
        • Ospedale San Giovanni Battista Molinette
      • Torino, Italy
        • Recruiting
        • Ospedale San Giovanni Battista Molinette
      • Torino, Italy
        • Not yet recruiting
        • San Giovanni Battista Molinette - Biologia Molecolare
      • Verona, Italy
        • Not yet recruiting
        • Policlinico GB Rossi
        • Principal Investigator:
          • Giovanni Pizzolo, PhD
    • VE
      • Mestre, VE, Italy
        • Not yet recruiting
        • Ospedale dell'Angelo
        • Principal Investigator:
          • Teodoro Chisesi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

  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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: 5 years
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.
Time Frame: 5 years
5 years
To evaluate if PET has a prognostic value in T-Lymphoblastic Lymphoma cases.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi ONLUS

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

April 15, 2009

First Submitted That Met QC Criteria

April 15, 2009

First Posted (Estimate)

April 16, 2009

Study Record Updates

Last Update Posted (Estimate)

October 13, 2011

Last Update Submitted That Met QC Criteria

October 12, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIL-LY_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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