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

Sponsor
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
Study ID
NCT00556127
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375 mg/m2 on day 1
  • Epirubicin — DRUG
    110 mg/m2 on day 3
  • Cyclophosphamide — DRUG
    1200 mg/m2 on day 3
  • Vincristine — DRUG
    1.4 mg/m2 (maximum 2 mg) on day 3
  • Prednisone — DRUG
    40 mg/m2 from day 1 to 5
  • Granulocyte-colony-stimulating factor — DRUG
    (G-CSF 5 μg/Kg/day) from day 5 to day 11
  • Mitoxantrone — DRUG
    8 mg/m2 for 3-day
  • Cytarabine ARA-C — DRUG
    2 g/m2/12 hours for six doses in 3-hour infusion
  • Dexamethasone — DRUG
    4 mg/m2/12 hours before ARA-C administration
  • Carmustine BCNU — DRUG
    300 mg/m2 on day -7
  • Etoposide — DRUG
    100 mg/m2/12 hours
  • Melphalan — DRUG
    140 mg/m2 on day -2
  • Radiotherapy — RADIATION
    Involved Field Radiotherapy (IF-RT)
  • PBSC reinfusion — PROCEDURE
    ASCT

Study Details

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

Key Dates

Start date
Jun 30, 2002
Status verified
Nov 2007
Completion
Sep 30, 2006

Study Design

Enrollment
94 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Failure-free survival [ Time Frame: Three years ]

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