S0213 Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma

Sponsor
SWOG Cancer Research Network
Study ID
NCT00041132
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • filgrastim — BIOLOGICAL
    5 ug/kg
  • rituximab — BIOLOGICAL
    375 mg/m\^2 on day 1 of cycles 1-6
  • cyclophosphamide — DRUG
    300 mg/m\^2 on days 2-4 of cycles 1,3,5,7
  • cytarabine — DRUG
    12 g/m\^2 over days 3-4 of cycles 2,4,6,8
  • dexamethasone — DRUG
    40 mg on days 2-5 and 12-15 of cycles 1,3,5,7
  • doxorubicin — DRUG
    16.6 mg/m\^2/day for days 5-7 of cycles 1,3,5,7
  • leucovorin — DRUG
    170 mg over days 3-5 of cycles 2,4,6,8
  • methotrexate — DRUG
    1000 mg/m\^2 over days 2-3 of cycles 2,4,6,8
  • vincristine — DRUG
    1.4 mg/m\^2 on days 5 and 12 of cycles 1,3,5,7

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining rituximab with chemotherapy may kill more cancer cells. PURPOSE: Phase II pilot study to study the effectiveness of combining chemotherapy with rituximab in treating patients who have newly diagnosed mantle cell lymphoma.

Key Dates

Start date
Sep 30, 2002
Status verified
Oct 2012
Primary completion
Nov 30, 2007
Completion
Jun 30, 2011

Study Design

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

Arms

  • Experimental: Hyper-CVAD + MTX/Ara-C + Rituximab
    21-day cycles of Hyper-CVAD and high-dose methotrexate/cytarabine are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6. Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m\^2 on day 1, mesna 600 mg/m\^2 on days 2-4, cyclophosphamide 300 mg/m\^2 on days 2-4, doxorubicin 16.6 mg/m\^2/day on days 5-7, vincristine 1.4 mg/m\^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and filgrastim 5 ug/kg on days 8-21. Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m\^2 on day 1, methotrexate 1000 mg/m\^2 over days 2-3, Ara-C 12 g/m\^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21.

Primary Outcome Measure

Progression-free Survival [ Time Frame: assessed after cycle 4, after completion of treatment, then every 3 months until 1 year after registration ]

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