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Phase IIb Study of Dasatinib Versus Imatinib in Patients With CML-CP Who Have Not Achieved an Early Optimal Response to Imatinib (Early switch)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01593254
First received: May 4, 2012
Last updated: November 6, 2014
Last verified: November 2014

May 4, 2012
November 6, 2014
August 2012
July 2019   (final data collection date for primary outcome measure)
Proportion of subjects who achieve Major Molecular Response (MMR) rate [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01593254 on ClinicalTrials.gov Archive Site
  • Molecular Response over time - Proportion of randomized subjects who achieve MMR, MR4 and MR4.5 at each time-point from Day 1 treatment with first line Imatinib [ Time Frame: Months 6, 12, 18, 24, 36, 48 & 60 ] [ Designated as safety issue: No ]

    MR4 = 4- log reduction in BCR-ABL transcript from the standardized baseline [0.01% International Standard (IS)]

    MR4.5 = 4.5- log reduction in BCR-ABL transcript from the standardized baseline [0.0032% International Standard (IS)]

  • Cytogenetic Response over time - proportion of randomized subjects who achieve Complete Cytogenetic Response (CCyR) or major cytogenetic response (MCyR) at each time-point from Day 1 treatment with first line Imatinib [ Time Frame: Months 6, 12 & 18 ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) - PFS is defined as the time from randomization date to progression date or death date, whichever occurs first. Subjects who neither progress nor die, will be censored [ Time Frame: Months 12, 18, 24, 36, 48 & 60 ] [ Designated as safety issue: No ]
  • Overall Survival (OS)- OS is defined as the time from randomization date to death date. Subjects who have not died, will be censored on the last date they are known to be alive [ Time Frame: Months 12, 18, 24, 36, 48 & 60 ] [ Designated as safety issue: No ]
  • Time to and duration of Response - Time to MMR is the time between randomization date and first date that MMR criteria are satisfied [ Time Frame: Months 6, 15, 18, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Time to and duration of Response - Time to MR4.5 is the time between randomization date and first date that MR4.5 criteria are satisfied [ Time Frame: Months 6, 12, 15, 18, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Time to and duration of Response - Time to MR4 is the time between randomization date and first date that MR4 criteria are satisfied [ Time Frame: Months 6, 12, 15, 18, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Time to and duration of Response - Time to CCyR is the time between randomization date and first date that CCyR criteria are satisfied [ Time Frame: Months 6, 12 and 18 ] [ Designated as safety issue: No ]
  • Time to and duration of Response - Time to MCyR is the time between randomization date and first date that MCyR criteria are satisfied [ Time Frame: Months 6, 12 and 18 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase IIb Study of Dasatinib Versus Imatinib in Patients With CML-CP Who Have Not Achieved an Early Optimal Response to Imatinib
An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib

The study purpose is to test the hypothesis that patients with Chronic phase-Chronic Myeloid Leukemia (CP-CML) with BCR-ABL transcript level > 10% International Standard (IS) after 3 months of treatment with first line Imatinib 400mg will achieve a greater rate of major molecular response (MMR) by early switching to Dasatinib therapy 100mg once daily (QD) compared with continued treatment with Imatinib at any dose.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Phase Chronic Myeloid Leukemia
  • Drug: Imatinib
    Other Name: Gleevac
  • Drug: Dasatinib
    Other Name: Sprycel
  • Experimental: Arm 1: Imatinib (≥400 mg)
    Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) depending on dose selected, up to 84 months
    Intervention: Drug: Imatinib
  • Experimental: Arm 2: Dasatinib (100 mg)
    Dasatinib 100 mg tablet by mouth QD up to 84 months
    Intervention: Drug: Dasatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
July 2019
July 2019   (final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • CP-CML Philadelphia chromosome positive (Ph+) patients with CHR but with BCR-ABL level >10% IS after 3 months of Imatinib 400 mg treatment. Imatinib monotherapy must have been started within 6 months of CP-CML diagnosis
  • Currently tolerating Imatinib 400 mg QD
  • Eastern Co-Operative Group (ECOG) performance status = 0 - 2
  • Adequate renal function defined as serum creatinine ≤ 3 times the institutional upper limit of normal (ULN)
  • Adequate hepatic function defined as:

    • Total Bilirubin ≤2.0 times institutional ULN
    • Alanine Aminotransferase (ALT) ≤2.5 times the institutional ULN
    • Aspartate Aminotransferase (AST) ≤2.5 times the institutional ULN
  • Serum Na, K, Mg, and total serum Ca or ionized Ca levels must be greater than or equal to the institutional lower limit of normal

Exclusion Criteria:

  • Accelerated Phase (AP)/ blast crisis (BP) diagnosis
  • Not in Complete Hematologic Response (CHR) by 3 month
  • Documented T315I/A, F317L, or V299L mutations
  • Prior Chronic Myeloid Leukemia (CML) treatment other than Imatinib
  • Serious, uncontrolled Medical condition
Both
18 Years and older
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
United States,   Argentina,   Austria,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   France,   Italy,   Korea, Republic of,   Poland,   Spain,   Thailand
 
NCT01593254
CA180-399, 2011-006181-41
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP