Trial | NCT00556127  Report issue

Title

Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma
Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    94
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
Study Started
Jun 30
2002
Study Completion
Sep 30
2006
Last Update
Nov 09
2007
Estimate

Drug Vincristine

1.4 mg/m2 (maximum 2 mg) on day 3

Drug Prednisone

40 mg/m2 from day 1 to 5

Drug Rituximab

375 mg/m2 on day 1

Drug Epirubicin

110 mg/m2 on day 3

Drug Cyclophosphamide

1200 mg/m2 on day 3

Drug Granulocyte-colony-stimulating factor

(G-CSF 5 μg/Kg/day) from day 5 to day 11

Drug Mitoxantrone

8 mg/m2 for 3-day

Drug Cytarabine ARA-C

2 g/m2/12 hours for six doses in 3-hour infusion

Drug Dexamethasone

4 mg/m2/12 hours before ARA-C administration

Drug Carmustine BCNU

300 mg/m2 on day -7

Drug Etoposide

100 mg/m2/12 hours

Drug Melphalan

140 mg/m2 on day -2

Radiation Radiotherapy

Involved Field Radiotherapy (IF-RT)

Procedure PBSC reinfusion

ASCT

1 Experimental

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.
No Results Posted