Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
• Treatments: Carmustine; Cyclophosphamide; Cytarabine; Dexamethasone; Epirubicin; Etoposide; Lenograstim; Melphalan; Mitoxantrone; Prednisone; Rituximab; Sargramostim; Vincristine

Criteria

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.