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 Details
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 | Phase |
|---|---|---|
|
Detailed Description
Observational prospective Clinical Trial designed to:
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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;
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enter classic T-LBL patients (bone marrow infiltrate <25%) treated as long as previous section;
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monitor therapy response/phenotype ratio by the study of phenotype;
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monitor therapy response/residual disease/patients outcome ratio by the study of T-cell receptor gene rearrangement;
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evaluate any gene-profile difference between T-LBL pre-thymic phenotype and T-LBL thymic phenotype so as to correlate it to outcome;
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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
Arms and Interventions
| Arm | 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
- To create a prospective database of T-lymphoblastic lymphoma cases on adult patients in order to conduct an appropriate statistical study. [5 years]
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. [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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no previous therapy, except for treatments to face up to clinical presentation of emergency;
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medical history initially characterized by nodal mass/masses;
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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;
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availability of biological material for the study of TCR and gene-profile;
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age ≥ 15 years;
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all stages;
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infiltrated bone marrow <25%;
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normal liver, renal and cardiac functions, except for alterations directly related to lymphoma;
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estimates of treatment according to one of the last generation schedules;
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written informed consent.
Exclusion Criteria:
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patients with previous HCV, HBsAg+ or suffering from HIV;
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patients with organic pathology not related to lymphoma.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ospedale dell'Angelo | Mestre | VE | Italy | |
| 2 | Casa Sollievo della Sofferenza | Foggia | Italy | ||
| 3 | Ospedale San Martino | Genova | Italy | ||
| 4 | Ospedale Vito Fazzi | Lecce | Italy | ||
| 5 | Azienda Ospedaliera Papardo | Messina | Italy | ||
| 6 | Università degli studi di Modena | Modena | Italy | ||
| 7 | Policlinico San Matteo | Pavia | Italy | ||
| 8 | Ospedale Civile Santo Spirito | Pescara | Italy | ||
| 9 | Ospedale San Carlo | Potenza | Italy | ||
| 10 | Ospedale Bianche Melacrino Morelli | Reggio Calabria | Italy | ||
| 11 | Ospedale Sant'Eugenio | Roma | Italy | ||
| 12 | Università La Sapienza | Roma | Italy | ||
| 13 | Azienda Ospedaliera Sassari | Sassari | Italy | ||
| 14 | Ospedale San Giovanni Battista Molinette | Torino | Italy | ||
| 15 | Ospedale San Giovanni Battista Molinette | Torino | Italy | ||
| 16 | San Giovanni Battista Molinette - Biologia Molecolare | Torino | Italy | ||
| 17 | Policlinico GB Rossi | Verona | Italy |
Sponsors and Collaborators
- Fondazione Italiana Linfomi ONLUS
Investigators
- Study Director: Massimo Federico, MD, Azienda Ospedaliero-Universitaria di Modena (MO)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIL-LY_01