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Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

This study has been completed.
Sponsor:
Collaborators:
Klinikum Leverkusen gGmbH
ribosepharm GmbH
Mundipharma Research GmbH & Co KG
Information provided by (Responsible Party):
WiSP Wissenschaftlicher Service Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01423032
First received: August 19, 2011
Last updated: August 24, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Chronic Lymphocytic Leukemia
 Drug: bendamustine
Drug: Fludarabine
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by WiSP Wissenschaftlicher Service Pharma GmbH:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: the patients were followed on average for 36 months ] [ Designated as safety issue: No ]
    individual time-frame up to max. follow-up (Kaplan-Meier estimation)


Enrollment: 96
Study Start Date: September 2001
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423032

Locations
Germany
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
Investigators
Study Chair: Norbert Niederle, Prof, MD Med. Klinik III, Klinikum Leverkusen gGmbH, Germany
  More Information

No publications provided

Responsible Party: WiSP Wissenschaftlicher Service Pharma GmbH
ClinicalTrials.gov Identifier: NCT01423032     History of Changes
Other Study ID Numbers: WISP_RI05
Study First Received: August 19, 2011
Last Updated: August 24, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by WiSP Wissenschaftlicher Service Pharma GmbH:
relapsed

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Fludarabine
Fludarabine monophosphate
 Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 21, 2013