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
1 other identifier
interventional
65
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 18, 2009
CompletedFirst Posted
Study publicly available on registry
March 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedSeptember 15, 2015
December 1, 2010
3.3 years
March 18, 2009
September 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects
at 12 months
Secondary Outcomes (5)
safety after treatment with dasatinib
2 year
rate of Complete Cytogenetic Response(CCyR)
2 year
rate of Complete Hematologic Response (CHR)
2 year
efficacy on patients with BCR-ABL point mutations
2 year
progression free survival
2 year
Study Arms (1)
dasatinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Signed Written Informed Consent
- Subjects with chronic phase chronic myeloid leukemia (CML)
- Subjects resistant/intolerant to imatinib
- Subjects presenting:
- ECOG performance status (PS) score 0-2
- Adequate hepatic function
- Adequate renal function
- Adequate lung function
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677, Japan
Related Publications (1)
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. doi: 10.3960/jslrt.54.197.
PMID: 25501110DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hisashi Sakamaki, MD.PhD
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 18, 2009
First Posted
March 20, 2009
Study Start
March 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
September 15, 2015
Record last verified: 2010-12