Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423032
• Other study ID #: WISP_RI05
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 19, 2011
• Last updated: August 24, 2011
• Start date: September 2001
• Est. completion date: May 2009

Study information

• Verified date: August 2011
• Source: WiSP Wissenschaftlicher Service Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• bendamustine
100 mg/m² iv, day 1+2, q4w
• Fludarabine
25 mg/m² iv, days 1-5, q4w

Locations

Country	Name	City	State
Germany	Prof. Dr. Norbert Niederle	Leverkusen	NRW

Sponsors (4)

Lead Sponsor	Collaborator
WiSP Wissenschaftlicher Service Pharma GmbH	Klinikum Leverkusen gGmbH, Mundipharma Research GmbH & Co KG, ribosepharm GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	individual time-frame up to max. follow-up (Kaplan-Meier estimation)	the patients were followed on average for 36 months	No