A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
Epidemiological and Clinical Research Information Network
Information provided by:
Kanto CML Study Group
ClinicalTrials.gov Identifier:
NCT00866736
First received: March 18, 2009
Last updated: September 14, 2015
Last verified: December 2010

March 18, 2009
September 14, 2015
March 2009
June 2012   (final data collection date for primary outcome measure)
rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00866736 on ClinicalTrials.gov Archive Site
  • safety after treatment with dasatinib [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • rate of Complete Cytogenetic Response(CCyR) [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • rate of Complete Hematologic Response (CHR) [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • efficacy on patients with BCR-ABL point mutations [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Myeloid Leukemia
Drug: dasatinib
100mg QD
Other Name: BMS-354825
Experimental: dasatinib
Intervention: Drug: dasatinib
Inokuchi K, Kumagai T, Matsuki E, Ohashi K, Shinagawa A, Hatta Y, Takeuchi J, Yoshida C, Wakita H, Kozai Y, Shirasugi Y, Fujisawa S, Iwase O, Yano S, Okamoto S, Oba K, Sakamoto J, Sakamaki H. Efficacy of molecular response at 1 or 3 months after the initiation of dasatinib treatment can predict an improved response to dasatinib in imatinib-resistant or imatinib-intolerant Japanese patients with chronic myelogenous leukemia during the chronic phase. J Clin Exp Hematop. 2014;54(3):197-204.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed Written Informed Consent
  • Subjects with chronic phase chronic myeloid leukemia (CML)
  • Subjects resistant/intolerant to imatinib
  • Subjects presenting:

    1. ECOG performance status (PS) score 0-2
    2. Adequate hepatic function
    3. Adequate renal function
    4. Adequate lung function

Exclusion Criteria:

  • Concurrent malignancy other than CML
  • Women who are pregnant or breastfeeding
  • Concurrent pleural effusion
  • Uncontrolled or significant cardiovascular disease
  • A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
  • Prior therapy with dasatinib
  • Subjects with T315I and/or F317L BCR-ABL point mutations
Both
15 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00866736
KCSG-01
Yes
Not Provided
Not Provided
Hisashi Sakamaki, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Kanto CML Study Group
Epidemiological and Clinical Research Information Network
Principal Investigator: Hisashi Sakamaki, MD.PhD Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Kanto CML Study Group
December 2010

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