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Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive


Phase 2
18 Years
60 Years
Not Enrolling
Both
Diffuse Large B-Cell Lymphoma, POOR PROGNOSIS

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Trial Information

Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive


Inclusion Criteria:



- previously untreated aggressive B-cell lymphoma (Diffuse Large B-Cell,

- Primary Mediastinal,

- Follicular grade III b Lymphoma);

- age 18 to 60;

- III-IV Ann Arbor stage;

- 0-2 Eastern Cooperative Oncology Group (ECOG) performance status (PS);

- intermediate-high (IH) and high (H) risk score according to age-adjusted
International Prognostic Index (IPI).

- Patients with Primary Mediastinal Lymphoma were included only if they had advanced
stage III or IV disease.

Exclusion Criteria:

- HIV,

- hepatitis B or C virus seropositivity;

- CNS involvement at diagnosis;

- abnormal renal, pulmonary and hepatic function;

- left ventricular ejection fraction less than 45%;

- pregnancy.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Failure-free survival

Outcome Time Frame:

Three years

Principal Investigator

Umberto Vitolo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

S.C. Ematologia II - OSP.S. GIOV.BATTISTA MOLINETTE - TORINO (TO) -

Authority:

Italy: The Italian Medicines Agency

Study ID:

GIMURELL-DLBCL

NCT ID:

NCT00556127

Start Date:

June 2002

Completion Date:

September 2006

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • POOR PROGNOSIS
  • Large B-cell Lymphoma
  • Rituximab
  • ASCT
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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