A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

Phase 3

Completed

• Conditions: Myeloid Leukemia, Chronic
• Interventions: Drug: Dasatinib; Drug: Imatinib

• Registration Number: NCT00481247
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-31
• Study First Posted: 2007-06-01
• Study Start: 2007-09
• Primary Completion: 2009-12
• Results First Submitted: 2010-11-23
• Results First Submitted QC: 2011-02-18
• Results First Posted: 2011-03-15
• Study Completion: 2015-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-22
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 547

Inclusion Criteria

• Male or female, aged 18 years and older
• Chronic phase, Philadelphia Chromosome-positive chronic myeloid leukemia (CML)
• Eastern Cooperative Oncology Group Performance Status score of 0-2

Key

Exclusion Criteria

• Pleural Effusion
• Uncontrolled cardiovascular disease
• Significant bleeding disorder unrelated to CML
• Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dasatinib	Dasatinib	-
Imatinib	Imatinib	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months	Pretreatment, every 3 months up to 12 months	Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.

Secondary Outcome Measures

Name	Time	Method
Time to Confirmed Complete Cytogenic Response (cCCyR) Overall	Day 1 to 5 years	The time to cCCyR for all randomized participants is defined as the time from the randomization date until criteria are first met for complete cytogenic response (provided it is confirmed later). The time to cCCyR analysis censors nonresponders who do not progress at their last cytogenetic assessments and nonresponders who progress at the maximum time of all randomized participants.; .
Percentage of Participants With Major Molecular Response (MMR) at Any Time	Planned total follow-up duration of 5 years	Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
Percentage of Participants With Progression-free Survival (PFS)	Participants were followed-up for at least 5 years	PFS was defined as the time from randomization until progression (any progression/death within 30 days of last dosing date, or between 30-60 days of last dosing prior to start of secondary therapy). Those who did not progress/die or who progressed/died after 60 days of last dose were censored at last on-study hematologic/cytogenetic assessment; those with progression/death 30-60 days of last dosing date and after start date of secondary therapy censored at last on-study hematologic/cytogenetic assessment prior to start of secondary therapy; those who had not received study treatment censored on date randomized.
Time to Major Molecular Response (MMR) Overall	Day 1 to 5 years	The time to MMR for all randomized participants is defined as the time from randomization date until measurement criteria are first met for MMR. The time to MMR analysis censors nonresponders who do not progress at their last molecular assessments and nonresponders who progress at the maximum time of all randomized participants.
Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)	Years 2, 3, 4 and 5	Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.; Percentage of participants in cCCyR at years 2, 3, 4 and 5 was computed for all randomized participants who achieved cCCyR as measured from the time of first confirmation until the date of progression or death. Participants with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Participants without cCCyR are considered to have progressed on Day 1.
Percentage of Participants With Overall Survival (OS)	Participants were followed-up for at least 5 years	OS was defined as the time from randomization to the date of death. If the participant had not died, survival was censored on last date the participant was known to be alive.

Trial Locations

Locations (2)

Molecular Md; 🇺🇸 Portland, Oregon, United States

Local Institution; 🇹🇷 Kayseri, Turkey