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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00556127

Acronym

DLBCL

Enrollment

Registered

2007-11-09

Start date

2002-06-30

Completion date

2006-09-30

Last updated

2007-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-Cell Lymphoma, POOR PROGNOSIS

Keywords

Large B-cell Lymphoma, Rituximab, ASCT

Brief 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

Interventions

DRUGRituximab

375 mg/m2 on day 1

DRUGEpirubicin

110 mg/m2 on day 3

DRUGCyclophosphamide

1200 mg/m2 on day 3

DRUGVincristine

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

DRUGPrednisone

40 mg/m2 from day 1 to 5

DRUGGranulocyte-colony-stimulating factor

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

DRUGMitoxantrone

8 mg/m2 for 3-day

DRUGCytarabine ARA-C

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

DRUGDexamethasone

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

DRUGCarmustine BCNU

300 mg/m2 on day -7

DRUGEtoposide

100 mg/m2/12 hours

DRUGMelphalan

140 mg/m2 on day -2

RADIATIONRadiotherapy

Involved Field Radiotherapy (IF-RT)

PROCEDUREPBSC reinfusion

ASCT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame
Failure-free survival	Three years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026