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Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01423032
Recruitment Status : Completed
First Posted : August 25, 2011
Last Update Posted : August 25, 2011
Klinikum Leverkusen gGmbH
ribosepharm GmbH
Mundipharma Research GmbH & Co KG
Information provided by (Responsible Party):
WiSP Wissenschaftlicher Service Pharma GmbH

Brief Summary:

Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. This study assesses its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine.

Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine 100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of 25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior progression-free survival with bendamustine.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: bendamustine Drug: Fludarabine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV
Study Start Date : September 2001
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: Bendamustine Drug: bendamustine
100 mg/m² iv, day 1+2, q4w

Active Comparator: Fludarabine Drug: Fludarabine
25 mg/m² iv, days 1-5, q4w

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: the patients were followed on average for 36 months ]
    individual time-frame up to max. follow-up (Kaplan-Meier estimation)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • histologically or immunologically confirmed chronic B-cell leukemia
  • refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen
  • disease stage II-IV according to Rai or B/C according to Binet staging system, respectively
  • Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better
  • negative pregnancy test/ adequate method of contraception

Exclusion Criteria:

  • T-CLL, PLL (prolymphocytic leukemia)
  • presence of Richter's transformation
  • first-line treatment containing either fludarabine or bendamustine
  • acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin > 5mg/dl), renal system (creatinine > 2 mg/dl), or metabolic disorders
  • secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01423032

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Prof. Dr. Norbert Niederle
Leverkusen, NRW, Germany, D-51375
Sponsors and Collaborators
WiSP Wissenschaftlicher Service Pharma GmbH
Klinikum Leverkusen gGmbH
ribosepharm GmbH
Mundipharma Research GmbH & Co KG
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Study Chair: Norbert Niederle, Prof, MD Med. Klinik III, Klinikum Leverkusen gGmbH, Germany

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Responsible Party: WiSP Wissenschaftlicher Service Pharma GmbH Identifier: NCT01423032    
Other Study ID Numbers: WISP_RI05
First Posted: August 25, 2011    Key Record Dates
Last Update Posted: August 25, 2011
Last Verified: August 2011
Keywords provided by WiSP Wissenschaftlicher Service Pharma GmbH:
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine phosphate
Bendamustine Hydrochloride
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents