Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

NCT00872976 | Withdrawn Phase 1

• 1 other identifier: CA180-182
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose (MTD) as assessed by measuring dose limiting toxicities (DLT) at each dosing level

  From initial dose to the end of three cycles of treatment at each dosing level. Each cycle is 28 days, so approximately 91 days

Secondary Outcomes (2)

• 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)

  From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days

• The effects of treatment on various biological correlates will also be assayed

  From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days

Study Arms (2)

Cohort #1

EXPERIMENTAL

Drug: Dasatinib; Drug: Combination of Bendamustine + Dasatinib

Cohort #2

EXPERIMENTAL

Drug: Dasatinib; Drug: Combination of Bendamustine + Dasatinib

Interventions

Dasatinib DRUG

One Week Initial Treatment for Cohort #1: Dasatinib - Tablets/Oral Solution, at assigned dose level, once daily (QD)

Also known as: BMS-354825, Sprycel

Cohort #1

Combination of Bendamustine + Dasatinib DRUG

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

Also known as: Sprycel, Treanda

Cohort #1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Local Institution

New Hyde Park, New York, 11040, United States

Location

Local Institution

Columbus, Ohio, 43210, United States

Location

Local Institution

Nashville, Tennessee, 37203, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Dasatinib; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Butyrates; Acids, Acyclic; Carboxylic Acids; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 22, 2013

Record last verified: 2013-07

Locations

US (3)