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

Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

Status and phase: Completed; Phase 2

Conditions: POOR PROGNOSIS; Diffuse Large B-Cell Lymphoma

Treatments: Drug: Cyclophosphamide; Drug: Etoposide; Drug: Mitoxantrone; Radiation: Radiotherapy; Drug: Melphalan; Drug: Granulocyte-colony-stimulating factor; Drug: Cytarabine ARA-C; Procedure: PBSC reinfusion; Drug: Carmustine BCNU; Drug: Vincristine; Drug: Epirubicin; Drug: Dexamethasone; Drug: Prednisone; Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00556127

Eudract Number 2004-000543-19

GIMURELL-DLBCL

Details and patient eligibility

About

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

Enrollment: 94 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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94 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Prednisone

Drug: Cyclophosphamide

Drug: Rituximab

Drug: Dexamethasone

Procedure: PBSC reinfusion

Radiation: Radiotherapy

Drug: Carmustine BCNU

Drug: Epirubicin

Drug: Etoposide

Drug: Mitoxantrone

Drug: Vincristine

Drug: Granulocyte-colony-stimulating factor

Drug: Cytarabine ARA-C

Drug: Melphalan