Clinical Trials /

Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib

NCT01593254

Description:

The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.

Related Conditions:
  • Chronic Myeloid Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Open Label, Randomized Phase 2b Study of <span class="go-doc-concept go-doc-intervention">Dasatinib</span> vs <span class="go-doc-concept go-doc-intervention">Imatinib</span> in Patients With <span class="go-doc-concept go-doc-disease">Chronic Myeloid Leukemia</span> (<span class="go-doc-concept go-doc-disease">CML</span>) Who do Not Have Favorable <span class="go-doc-concept go-doc-intervention">Imatinib</span> Response (DASCERN)

Title

  • Brief Title: Open Label, Randomized Phase 2b Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who do Not Have Favorable Imatinib Response (DASCERN)
  • Official Title: 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
  • Clinical Trial IDs

    NCT ID: NCT01593254

    ORG ID: CA180-399

    NCI ID: 2011-006181-41

    Trial Conditions

    Chronic Phase Chronic Myeloid Leukemia

    Trial Interventions

    Drug Synonyms Arms
    Imatinib Gleevec, Glivec Arm 1: Imatinib (400 mg)
    Dasatinib Sprycel Arm 2: Dasatinib (100 mg)

    Trial Purpose

    The purpose of this study is to test the hypothesis that patients with CML who have not
    achieved optimal response after 3 months of treatment with imatinib will have a better
    response by switching to dasatinib compared to staying on their original imatinib regimen.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm 1: Imatinib (400 mg) Active Comparator Imatinib 400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months Imatinib
    Arm 2: Dasatinib (100 mg) Active Comparator Dasatinib 100 mg tablet by mouth QD up to 60 months Dasatinib

    Eligibility Criteria

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

    Inclusion Criteria:

    - Chronic Phase (CP)-CML Ph+ patients with CHR but with one log BCR-ABL reduction
    (BCR-ABL level >10% IS) 3 months of imatinib 400mg treatment. (Imatinib transient
    dose adjustments due to Adverse Event (AEs) are allowed with a maximum of 2 weeks
    interruption of treatment with imatinib (cumulative) within the 3 month period before
    randomization). Imatinib monotherapy must have been started within 6 months of CP-CML
    diagnosis (Ph + /BCR-ABL detection)

    - Currently tolerating imatinib 400mg QD. Patients with prior imatinib treatment
    interruption or dose reductions are required to be on treatment with 400 mg imatinib
    for two weeks immediately prior to randomization to ensure tolerance to imatinib

    - 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 the institutional
    ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 times
    the institutional ULN

    Exclusion Criteria:

    - Previous diagnosis of accelerated phase or blast crisis

    - Subjects with clonal evolution in Ph+ cells observed in 2 metaphases at baseline
    bone marrow cytogenetic test, unless the same abnormalities were present at
    diagnosis. Patients with no evidence of clonal evolution, including those patients
    whose cytogenetic testing fails or bone marrow aspiration is a dry tap at 3 months,
    are eligible for the study

    - Subjects with less than complete hematologic response (CHR) after 3 months of
    imatinib treatment or lost CHR after initial achievement

    - Documented T315I/A, F317L, or V299L mutations (if already available - not required
    for screening)

    - A serious uncontrolled medical disorder or active infection that would impair the
    ability of the subject to receive protocol therapy

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Proportion of subjects who achieve Major Molecular Response (MMR) rate

    Secondary Outcome Measures

    Time to MMR - Time to MMR is the time between randomization date and first date that MMR criteria are satisfied

    Time to MR4.5 - Time to Molecular response (MR)4.5 is the time between randomization date and first date that MR4.5 criteria are satisfied

    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

    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

    Trial Keywords