Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

This study has been withdrawn prior to enrollment.
(Business Objectives Changed)
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00872976
First received: March 31, 2009
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine the recommended dose for the combination of dasatinib and bendamustine in chronic lymphocytic leukemia (CLL).


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Dasatinib
Drug: Combination of Bendamustine + Dasatinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Trial of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Determine the maximum tolerated dose (MTD) as assessed by measuring dose limiting toxicities (DLT) at each dosing level [ Time Frame: From initial dose to the end of three cycles of treatment at each dosing level. Each cycle is 28 days, so approximately 91 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All response evaluable subjects Cohorts #1 and #2 are assessed for overall response rate(s): complete remission (CR); CR with incomplete marrow recovery (CRi); partial remission (PR); for progressive disease (PD) or stable disease (SD) [ Time Frame: From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days ] [ Designated as safety issue: No ]
  • The effects of treatment on various biological correlates will also be assayed [ Time Frame: From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort #1 Drug: Dasatinib
One Week Initial Treatment for Cohort #1: Dasatinib - Tablets/Oral Solution, at assigned dose level, once daily (QD)
Other Names:
  • BMS-354825
  • Sprycel
Drug: Combination of Bendamustine + Dasatinib

Dasatinib, Tablets/Oral Solution, Oral, 50 mg, then at 80 mg, at 80 mg, and at 100 mg, once daily (QD), at assigned ascending dose, for 28 day cycles for a maximum of six cycles

Bendamustine, injection, IV injection, 50 mg/m²/Day 1 and Day 2, then at 50 mg/m², at 70 mg/m², at 70 mg/m², at assigned ascending dose, once daily 30 minute IV infusion Day 1 and Day 2 for a maximum of six cycles

Other Names:
  • Sprycel
  • Treanda
Experimental: Cohort #2 Drug: Dasatinib
One Week Initial Treatment for Cohort #2: Dasatinib - Tablets/Oral Solution, at 100 mg, once daily (QD)
Other Names:
  • BMS-354825
  • Sprycel
Drug: Combination of Bendamustine + Dasatinib

Dasatinib, Tablets/Oral Solution, Oral, at 100 mg, once daily (QD), for 28 day cycles for maximum of six cycles

Bendamustine, injection, IV injection, 100 mg/m²/Day 1 and Day 2, once daily 30 minute IV infusion Day 1 and Day 2 for maximum of six cycles

Other Names:
  • Treanda
  • Sprycel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Cohort #1):

  • Diagnosis of B-CLL by NCI criteria
  • Require chemotherapy and have fully recovered from previous administered chemotherapy
  • Subjects must have progressed, failed to achieve a meaningful response, or relapsed/intolerant to prior therapy. Failing at least one purine analogue regimen
  • Subjects have received three or fewer prior treatment regimens
  • ECOG status of 0 - 2

Inclusion Criteria (Cohort #2):

  • If dose level + 3 is reached, the criteria is the same as outlined for Cohort #1, however the subjects should not have a history of prior chemotherapy (treatment naive)

Exclusion Criteria:

  • Unwilling or unable to use an acceptable method to avoid pregnancy
  • Uncontrolled or significant cardiovascular disease, including prolonged QTc interval
  • History of significant bleeding disorder, unrelated to CLL
  • Prior concurrent malignancy
  • Drugs that generally accepted to have the risk of causing Torsades de Pointes
  • Autoimmune hemolytic anemia requiring therapy or transfusion support
  • Autoimmune thrombocytopenia requiring steroid therapy or transfusion support
  • Richter's Syndrome
  • Transformation to prolymphocytic leukemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872976

Locations
United States, New York
Local Institution
New Hyde Park, New York, United States, 11040
United States, Ohio
Local Institution
Columbus, Ohio, United States, 43210
United States, Tennessee
Local Institution
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers squibb
ClinicalTrials.gov Identifier: NCT00872976     History of Changes
Other Study ID Numbers: CA180-182
Study First Received: March 31, 2009
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Nitrogen Mustard Compounds
Dasatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014