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

Tracking Information

First Received Date ^ICMJE

August 19, 2011

Last Updated Date

August 24, 2011

Start Date ^ICMJE

September 2001

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01423032 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Lymphocytic Leukemia

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Bendamustine
Intervention: Drug: bendamustine
Active Comparator: Fludarabine
Intervention: Drug: Fludarabine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01423032

Other Study ID Numbers ^ICMJE

WISP_RI05

Has Data Monitoring Committee

Responsible Party

WiSP Wissenschaftlicher Service Pharma GmbH

Study Sponsor ^ICMJE

WiSP Wissenschaftlicher Service Pharma GmbH

Collaborators ^ICMJE

Klinikum Leverkusen gGmbH
ribosepharm GmbH
Mundipharma Research GmbH & Co KG

Investigators ^ICMJE

Study Chair:

Norbert Niederle, Prof, MD

Med. Klinik III, Klinikum Leverkusen gGmbH, Germany

Information Provided By

WiSP Wissenschaftlicher Service Pharma GmbH

Verification Date

August 2011

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

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