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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


N/A
15 Years
N/A
Open (Enrolling)
Both
Lymphoblastic Lymphoma

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Massimo Federico, MD

Investigator Role:

Study Director

Investigator Affiliation:

Azienda Ospedaliero-Universitaria di Modena (MO)

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

IIL-LY_01

NCT ID:

NCT00882011

Start Date:

April 2009

Completion Date:

April 2019

Related Keywords:

  • Lymphoblastic Lymphoma
  • T-lymphoblastic lymphoma
  • Intensive chemo/radiotherapy
  • Intensive chemotherapy
  • Transplant
  • Adult patients
  • Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, Non-Hodgkin

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