A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy

Leukemia Clinical Trial

Official title:

An Open-Label Randomized Phase III Study of Dasatinib vs. High-Dose (600 mg) Imatinib Mesylate in the Treatment of Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Are Imatinib Failures or Who Have Had a Suboptimal Response After 3-18 Months of Therapy With 400 mg Imatinib

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00362466
• Other study ID #: CA180-044
• Status: Terminated
• Phase: Phase 3
• First received: August 9, 2006
• Last updated: November 18, 2009
• Start date: April 2007
• Est. completion date: June 2008

Study information

• Verified date: November 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women =18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg

• Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis

• Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2

• Adequate hepatic and renal function

Exclusion Criteria:

• Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant

• Previous diagnosis of accelerated/blast crisis CML

• Subjects with clonal evolution in Ph+ cells observed in =2 metaphases

• Previous documentation of T315I mutation

• Uncontrolled or significant cardiovascular disease

• Serious uncontrolled medical disorder/active infection

• History of significant bleeding disorder unrelated to CML

• Intolerance to imatinib =400 mg

• Concurrent malignancies other than CML

Study Design

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Drug:
• Dasatinib
Tablets, Oral, Once daily, 5-7 years
• Imatinib
Tablets, Oral, Once daily, 5-7 years

Locations

Country	Name	City	State
United States	Local Institution	Alhambra	California
United States	Local Institution	Anaheim	California
United States	Local Institution	Ann Arbor	Michigan
United States	Local Institution	Aurora	Colorado
United States	Local Institution	Baltimore	Pennsylvania
United States	Local Institution	Beverly Hills	California
United States	Local Institution	Buffalo	New York
United States	Local Institution	Chicago	Illinois
United States	Local Institution	Cleveland	Ohio
United States	Local Institution	Dallas	Texas
United States	Local Institution	Durham	North Carolina
United States	Local Institution	Fullerton	California
United States	Local Institution	Hackensack	New Jersey
United States	Local Institution	Hazard	Kentucky
United States	Local Institution	Houston	Texas
United States	Dr. Marshall Schreeder	Huntsville	Alabama
United States	Local Institution	Indianapolis	Indiana
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Kansas City	Kansas
United States	Local Institution	La Jolla	California
United States	Local Institution	La Verne	California
United States	Local Institution	Las Vegas	Nevada
United States	Local Institution	Little Rock	Arkansas
United States	Local Institution	Long Beach	California
United States	Local Institution	Los Angeles	California
United States	Local Institution	Los Angeles	California
United States	Local Institution	Los Angeles	California
United States	New York Presbyterian Hospital	New York	New York
United States	Local Institution	Northridge	California
United States	Local Institution	Oklahoma City	Oklahoma
United States	Local Institution	Omaha	Nebraska
United States	M.D. Anderson Cancer Center Orlando	Orlando	Florida
United States	Local Institution	Oxnard	California
United States	Local Institution	Pembroke Pines	Florida
United States	Local Institution	Pittsburgh	Pennsylvania
United States	Local Institution	Redondo Beach	California
United States	Local Institution	Rochester	Minnesota
United States	Local Institution	San Francisco	California
United States	Local Institution	Santa Maria	California
United States	Local Institution	St. Louis	Missouri
United States	Local Institution	Stanford	California
United States	Santee Hematology/Oncology	Sumter	South Carolina
United States	Local Institution	Tulsa	Oklahoma
United States	New York Medical College	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Cytogenetic Response (CCyR) Rate at Month 6		Month 6	No
Secondary	Major Molecular Response (MMR) Rates		Month 3, Month 6, Month 12, Month 24 and Month 36	No
Secondary	CCyR Rates		Month 3, Month 12, Month 24 and Month 36	No
Secondary	Estimate Time to MMR and CCyR		throughout the study	No
Secondary	Progression Free Survival (PFS)		at 36 months	No
Secondary	Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs		From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible.	Yes
Secondary	Duration of CCyR and MMR		Throughout the study	No
Secondary	Best MMR Rates		throughout study	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm