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NCT Number: NCT01423032

Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Prof. Dr. Norbert Niederle

Leverkusen, North Rhine-Westphalia, D-51375, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bendamustine

Drug

100 mg/m² iv, day 1+2, q4w

Fludarabine

Drug

25 mg/m² iv, days 1-5, q4w

Primary outcomes

  1. progression-free survival

    Time frame: the patients were followed on average for 36 months

    individual time-frame up to max. follow-up (Kaplan-Meier estimation)

Sponsors and collaborators

Lead sponsor

WiSP Wissenschaftlicher Service Pharma GmbH

Other

Collaborators

  • Klinikum Leverkusen gGmbH
  • Mundipharma Research GmbH & Co KG
  • ribosepharm GmbH

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Aug 25, 2011
Registry last updated
Aug 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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