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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

August 19, 2011
August 24, 2011
September 2001
May 2009   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01423032 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • Drug: bendamustine
    100 mg/m² iv, day 1+2, q4w
  • Drug: Fludarabine
    25 mg/m² iv, days 1-5, q4w
  • Experimental: Bendamustine
    Intervention: Drug: bendamustine
  • Active Comparator: Fludarabine
    Intervention: Drug: Fludarabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
May 2009
May 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01423032
WISP_RI05
No
WiSP Wissenschaftlicher Service Pharma GmbH
WiSP Wissenschaftlicher Service Pharma GmbH
  • Klinikum Leverkusen gGmbH
  • ribosepharm GmbH
  • Mundipharma Research GmbH & Co KG
Study Chair: Norbert Niederle, Prof, MD Med. Klinik III, Klinikum Leverkusen gGmbH, Germany
WiSP Wissenschaftlicher Service Pharma GmbH
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP