Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)

Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study ID
NCT01118234
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation

Study Details

The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy.

Key Dates

Start date
Dec 31, 2009
Status verified
Jan 2020
Primary completion
Feb 28, 2018
Completion
Jul 31, 2019

Study Design

Enrollment
256 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Treatment with Rituximab 375 mg/m² every 3 months for 24 months
  • No Intervention: Observation
    Observation for 24 months

Primary Outcome Measure

progression free survival [ Time Frame: 48 months ]

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