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

NCT01558167 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-05-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Bendamustine, Rituximab, Lenalidomide

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

Sponsors & Collaborators

  • Mundipharma Research GmbH & Co KG

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Celgene

    collaborator INDUSTRY

  • German CLL Study Group

    lead OTHER

Principal Investigators

  • Michael Hallek, Prof.Dr. · German CLL Study Group

  • Clemens Wendtner, Prof.Dr. · German CLL Study Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-10-31
Completion
2015-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01558167 on ClinicalTrials.gov