Clinical trial NCT00362466: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Leukemia
Keywords: Leukemia (chronic myeloid leukemia - chronic phase)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-08-10
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Complete Cytogenetic Response (CCyR) Rate at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Major Molecular Response (MMR) Rates
timeFrame: Month 3, Month 6, Month 12, Month 24 and Month 36
measure: CCyR Rates
timeFrame: Month 3, Month 12, Month 24 and Month 36
measure: Estimate Time to MMR and CCyR
timeFrame: throughout the study
measure: Progression Free Survival (PFS)
timeFrame: at 36 months
measure: Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
timeFrame: 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.
measure: Duration of CCyR and MMR
timeFrame: Throughout the study
measure: Best MMR Rates
timeFrame: throughout study
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Dr. Marshall Schreeder
state: Alabama
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Alhambra
country: United States
facility: Local Institution
state: California
city: Anaheim
country: United States
facility: Local Institution
state: California
city: Beverly Hills
country: United States
facility: Local Institution
state: California
city: Fullerton
country: United States
facility: Local Institution
state: California
city: La Jolla
country: United States
facility: Local Institution
state: California
city: La Verne
country: United States
facility: Local Institution
state: California
city: Long Beach
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Northridge
country: United States
facility: Local Institution
state: California
city: Oxnard
country: United States
facility: Local Institution
state: California
city: Redondo Beach
country: United States
facility: Local Institution
state: California
city: San Francisco
country: United States
facility: Local Institution
state: California
city: Santa Maria
country: United States
facility: Local Institution
state: California
city: Stanford
country: United States
facility: Local Institution
state: California
city: Aurora
country: United States
facility: Local Institution
state: Colorado
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Orlando
country: United States
facility: M.D. Anderson Cancer Center Orlando
state: Florida
city: Pembroke Pines
country: United States
facility: Local Institution
state: Florida
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Kansas City
country: United States
facility: Local Institution
state: Kansas
city: Hazard
country: United States
facility: Local Institution
state: Kentucky
city: Ann Arbor
country: United States
facility: Local Institution
state: Michigan
city: Rochester
country: United States
facility: Local Institution
state: Minnesota
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: Omaha
country: United States
facility: Local Institution
state: Nebraska
city: Las Vegas
country: United States
facility: Local Institution
state: Nevada
city: Hackensack
country: United States
facility: Local Institution
state: New Jersey
city: Buffalo
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Durham
country: United States
facility: Local Institution
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Tulsa
country: United States
facility: Local Institution
state: Oklahoma
city: Baltimore
country: United States
facility: Local Institution
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Sumter
country: United States
facility: Santee Hematology/Oncology
state: South Carolina
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: