A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.

Sponsor
Hoffmann-La Roche
Study ID
NCT01144403
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    as prescribed, 6 cycles
  • Fludarabine — DRUG
    as prescribed, 6 cycles
  • Mitoxantrone — DRUG
    as prescribed, 6 cycles
  • Rituximab — DRUG
    375 mg/m\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles

Study Details

This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Participants will receive MabThera (372 mg/m\^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In participants experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles.

Key Dates

Start date
Jun 30, 2010
Status verified
Jul 2016
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014

Study Design

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

Arms

  • Experimental: Rituximab
    Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 50 months (approximately) ]

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