search
Back to results

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

Primary Purpose

Chronic Myeloid Leukemia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
dasatinib
Sponsored by
Kanto CML Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring chronic myeloid leukemia, dasatinib, chronic phase myeloid leukemia

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dasatinib

Arm Description

Outcomes

Primary Outcome Measures

rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects

Secondary Outcome Measures

safety after treatment with dasatinib
rate of Complete Cytogenetic Response(CCyR)
rate of Complete Hematologic Response (CHR)
efficacy on patients with BCR-ABL point mutations
progression free survival

Full Information

First Posted
March 18, 2009
Last Updated
September 14, 2015
Sponsor
Kanto CML Study Group
Collaborators
Epidemiological and Clinical Research Information Network
search

1. Study Identification

Unique Protocol Identification Number
NCT00866736
Brief Title
A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
Official Title
A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kanto CML Study Group
Collaborators
Epidemiological and Clinical Research Information Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
chronic myeloid leukemia, dasatinib, chronic phase myeloid leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dasatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
dasatinib
Other Intervention Name(s)
BMS-354825
Intervention Description
100mg QD
Primary Outcome Measure Information:
Title
rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
safety after treatment with dasatinib
Time Frame
2 year
Title
rate of Complete Cytogenetic Response(CCyR)
Time Frame
2 year
Title
rate of Complete Hematologic Response (CHR)
Time Frame
2 year
Title
efficacy on patients with BCR-ABL point mutations
Time Frame
2 year
Title
progression free survival
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisashi Sakamaki, MD.PhD
Organizational Affiliation
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25501110
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs