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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Bristol-Myers Squibb
Sponsor:
Collaborators:
ICON Clinical Research
PPD
Molecular MD
MultiPharma
Q2 solutions
Donald E. Morisky
MD Anderson Symptom Inventory (MDASI-CML)
OBiS, Inc
Steering Committee
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01593254
First received: May 4, 2012
Last updated: August 23, 2016
Last verified: August 2016

May 4, 2012
August 23, 2016
October 2012
January 2022   (final data collection date for primary outcome measure)
Percentage of patients achieving optimal response after 12 months of CML treatment [ Time Frame: 12 months after the first day treatment with first-line imatinib ] [ Designated as safety issue: No ]
Proportion of subjects who achieve Major Molecular Response (MMR) rate [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01593254 on ClinicalTrials.gov Archive Site
  • Time to Major Molecular Response (MMR) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Time to MMR is how fast patients achieve optimal response. It is the time between randomization date and first date that MMR criteria are satisfied.
  • Time to Molecular Response (MR)^4.5 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Time to MR^4.5 is how fast patients achieve a deeper response. It is the time between randomization date and first date that MR^4.5 criteria are satisfied.
  • Progression Free Survival (PFS) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    PFS is how long patients are likely to live without progression of their disease. It is the time from randomization date to progression date or death date, whichever occurs first.
  • Overall Survival (OS) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    OS is how long patients are likely to remain alive. It is the time from randomization date to death date.
  • 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 ]
Not Provided
Not Provided
 
Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable 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 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.
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 Names:
    • Gleevec
    • Glivec
  • Drug: Dasatinib
    Other Name: Sprycel
  • Active Comparator: Arm 1: Imatinib (≥400 mg)
    Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months
    Intervention: Drug: Imatinib
  • Active Comparator: Arm 2: Dasatinib (100 mg)
    Dasatinib 100 mg tablet by mouth QD up to 60 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
258
January 2022
January 2022   (final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Chronic Phase (CP)-CML Ph+ patients with complete hematologic response (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 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
Both
18 Years and older   (Adult, Senior)
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,   Hungary,   Italy,   Korea, Republic of,   Poland,   Spain,   Thailand
 
NCT01593254
CA180-399, 2011-006181-41
Yes
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
  • ICON Clinical Research
  • PPD
  • Molecular MD
  • MultiPharma
  • Q2 solutions
  • Donald E. Morisky
  • MD Anderson Symptom Inventory (MDASI-CML)
  • OBiS, Inc
  • Steering Committee
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2016

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