A Safety and Efficacy Trial of a Combination of Bendamustine, Rituximab and Lenalidomide in Patients With Chronic Lymphocytic Leukemia

Sponsor
German CLL Study Group
Study ID
NCT01558167
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bendamustine, Rituximab, Lenalidomide — DRUG
    Bendamustine: 50 mg/m2, i.v., day 1+2 Rituximab: Cycle 1: 375 mg/m2, i.v. day 0; Cycle 2-6: 500mg/m2, i.v., day 1 Lenalidomide: * Dose level 1: Cycle 1-6: 2,5mg p.o., d1-28 * Dose level 2: Cycle 1: 2,5mg p.o., d1-28; Cycle 2-6: 5mg p.o., d1-28 * Dose level 3: Cycle 1: 2,5mg p.o., d1-28; Cycle 2:5mg p.o., d1-28; Cycle 3-6: 10 mg p.o., d1-28 * Dose level 4: Cycle 1: 2,5mg p.o., d1-28; Cycle 2:5mg p.o., d1-28; Cycle 3: 10 mg p.o.,d1-28, Cycle 4-6: 15 mg p.o.,d1-28 * Dose level 5: maximal tolerated dose

Study Details

This is a prospective, multicenter, open label, non-randomized, phase I/II-study to define safety and efficacy of BRL combination in relapsed/refractory patients and to recommend a safe and efficacious dose for future phase II/III study. Hypothesis: The simultaneous administration of BRL in relapsed CLL is feasible, safe and efficient.

Key Dates

Start date
Feb 28, 2011
Status verified
May 2018
Primary completion
Oct 31, 2013
Completion
Jun 30, 2015

Study Design

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

Arms

  • Experimental: Bendamustine, Rituximab,Lenalidomide
    Dose modification treatment plan of lenalidomide

Primary Outcome Measure

dose limiting toxicity [ Time Frame: After 28 days of dosing at the respective target dose level of lenalidomide ]

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