Trial | NCT01423032  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    96
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.
Study Started
Sep 30
2001
Primary Completion
May 31
2009
Study Completion
May 31
2009
Last Update
Aug 25
2011
Estimate

Drug bendamustine

100 mg/m² iv, day 1+2, q4w

Drug Fludarabine

25 mg/m² iv, days 1-5, q4w

Bendamustine Experimental

Fludarabine Active Comparator

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)
No Results Posted