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
NCT ID: NCT00882011
Last Updated: 2011-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2009-04-30
2019-04-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Arm 1
Adult patients with T-lymphoblastic lymphoma treated with intensive chemo/radiotherapy or intensive chemotherapy followed by transplant.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 organic pathology not related to lymphoma.
15 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Massimo Federico, MD
Role: STUDY_DIRECTOR
Azienda Ospedaliero-Universitaria di Modena (MO)
Locations
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Ospedale dell'Angelo
Mestre, VE, Italy
Casa Sollievo della Sofferenza
Foggia, , Italy
Ospedale San Martino
Genova, , Italy
Ospedale Vito Fazzi
Lecce, , Italy
Azienda Ospedaliera Papardo
Messina, , Italy
Università degli studi di Modena
Modena, , Italy
Policlinico San Matteo
Pavia, , Italy
Ospedale Civile Santo Spirito
Pescara, , Italy
Ospedale San Carlo
Potenza, , Italy
Ospedale Bianche Melacrino Morelli
Reggio Calabria, , Italy
Ospedale Sant'Eugenio
Roma, , Italy
Università La Sapienza
Roma, , Italy
Azienda Ospedaliera Sassari
Sassari, , Italy
Ospedale San Giovanni Battista Molinette
Torino, , Italy
Ospedale San Giovanni Battista Molinette
Torino, , Italy
San Giovanni Battista Molinette - Biologia Molecolare
Torino, , Italy
Policlinico GB Rossi
Verona, , Italy
Countries
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Central Contacts
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Other Identifiers
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IIL-LY_01
Identifier Type: -
Identifier Source: org_study_id