Dose Dense Chemotherapy + Rituximab +/-Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous Stem Cell in Diffuse Large B-Cell Lymphoma

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT00499018
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    375 mg/m2 day 1
  • Ciclofosfamide — DRUG
    1200 mg/m2 day 1
  • Doxorubicina — DRUG
    70 mg/m2 day 1
  • Vincristina — DRUG
    1,4 mg/m2 (max 2 mg) day 1
  • Prednisone — DRUG
    100 mg day g 1-5
  • Pegfilgrastim — DRUG
    6 mg day +1
  • Mitoxantrone — DRUG
    8 mg/m2/days 1-3
  • ARA-C — DRUG
    2000 mg/m2/12h day 1 - 3
  • Lenograstim — DRUG
    5 μg/Kg/days +2
  • BCNU — DRUG
    300 mg/m2 day -7
  • ARA-C — DRUG
    200 mg/m2/12 days -6,-5,-4,-3
  • VP-16 — DRUG
    100 mg/m2/12h days -6,-5,-4,-3
  • ASCT — PROCEDURE
    PBSC Reinfusion
  • Ciclofosfamide — DRUG
    750 mg/m2 day 1
  • Doxorubicina — DRUG
    50 mg/m2 day 1
  • Vincristina — DRUG
    1,4 mg/m2 (max 2 mg) day 1

Study Details

The purpose of this study is to define an improvement in patients randomized in four different arms: Arm 1: R-MegaCHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 1BIS: R-CHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 2: R-MegaCHOP14x4 + R-MegaCHOP14x2; Arm 2BIS: R-CHOP14x4 + R-CHOP14x4; Which are different in dose dense chemotherapy + Rituximab with or without intensified high dose chemoimmunotherapy and support of peripheral autologous stem cells.

Key Dates

Start date
Jan 31, 2006
Status verified
Feb 2011
Primary completion
Jun 30, 2011
Completion
Sep 30, 2013

Study Design

Enrollment
399 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    R-MegaCHOP14 x 4 Restaging + R-MAD + MAD + BEAM + ASCT
  • Experimental: 1 BIS
    R-CHOP14 x 4 Restaging + R-MAD + MAD + BEAM + ASCT
  • Experimental: 2
    R-MegaCHOP14 x 4 Restaging + R-MegaCHOP x 2
  • Experimental: 2 BIS
    R-CHOP14 x 4 Restaging + R-CHOP14 x 4

Primary Outcome Measure

To evaluate the activity of arms "R-MegaCHOP14/R-CHOP14 + R-MAD+BEAM and ASCT" and "R-MegaCHOP14/R-CHOP14" in terms of 2-years Failure Free Survival (FFS). [ Time Frame: 2 years ]

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