Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

Sponsor

WiSP Wissenschaftlicher Service Pharma GmbH (Other)

Overall Status

Completed

CT.gov ID

NCT01423032

Collaborator

Klinikum Leverkusen gGmbH (Other), ribosepharm GmbH (Other), Mundipharma Research GmbH & Co KG (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Sep 1, 2001

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)