Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin's Lymphoma

Sponsor
Lymphoma Study Association
Study ID
NCT00169208
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    375 mg/m² IV, D1 each cycle during 4 cycles
  • fludarabine — DRUG
    40 mg/m²/day IV , D1 each cycle during 4 cycles
  • mitoxantrone — DRUG
    10 mg/m² IV, D2-3-4 each cycle during 4 cycles

Study Details

This study is a multicentric trial evaluating the efficacy of the RFM regimen in patients aged 18 to 75 years with relapsed/refractory follicular non-Hodgkin's lymphoma (NHL).

Key Dates

Start date
Apr 30, 2001
Status verified
Aug 2019
Primary completion
Dec 31, 2006
Completion
Dec 31, 2006

Study Design

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

Arms

  • Experimental: Experimental
    4 cycles of rituximab + fludarabine + mitoxantrone

Primary Outcome Measure

to evaluate progression free survival after a combination of rituximab, fludarabine and mitoxantrone (RFM) in patients with relapsed or primary failing advanced follicular non-Hodgkin's lymphoma. [ Time Frame: 2 years ]

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