Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL

Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study ID
NCT00738829
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility Criteria

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

Interventions

  • Lenalidomide — DRUG
    Dose escalation stage: starting dose 2.5mg/d, dose escalation via 5/10/15/20/25 mg/d every 28 days if no dose-limiting toxicity. During maintenance stage dosing on days 1-28 for max. 6 months at maximum tolerated dose reached during dose escalation stage.
  • Fludarabine — DRUG
    25 mg/m2 i.v. d1-3 or 40 mg/m2 po d1-3 every 28 days for 6 cycles during dose escalation stage.
  • Rituximab — BIOLOGICAL
    Dose escalation stage: 375 mg/m2 i.v. d4 Cycle 1, 500 mg/m2 i.v. d1 Cycles 2-6. Maintenance stage: 375 mg/m2 i.v. at 2/4/6 months after end of escalation stage.

Study Details

The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.

Key Dates

Start date
Oct 31, 2008
Status verified
Aug 2013
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

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

Arms

  • Experimental: Treatment Arm
    Lenalidomide Dose Escalation combined with Fludarabine/Rituximab followed by maximum tolerated lenalidomide dose/Rituximab maintenance therapy

Primary Outcome Measure

Lenalidomide Maximum Tolerated Dose [ Time Frame: Dose escalation stage ]

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