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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 14 July 2014
Main ID:  NCT00255346
Date of registration: 16/11/2005
Primary sponsor: M.D. Anderson Cancer Center
Public title: Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)
Scientific title: Therapy of Myeloid Metaplasia-Myelofibrosis, Atypical Chronic Myeloid or Myelomonocytic Leukemia, C-Kit Positive Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (AML-MDS), Hypereosinophilic Syndrome, Polycythemia Vera, and Mastocytosis With Dasatinib (BMS-354825)
Date of first enrolment: November 2005
Target sample size: 145
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT00255346
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients >/= 18 years old who meet the following eligibility criteria

2. Patients must have one of the following hematopoietic malignancies: C-kit positive
(10% or more BM or PB MNC positive by flow) acute myeloid leukemia (AML excluding
acute promyelocytic leukemia) or myelodysplastic syndrome (MDS) of the following
types: Refractory-relapse AML-MDS including those who fail to achieve CR after the
first cycle of induction; Second or subsequent AML-MDS refractory-relapse; Newly
diagnosed AML-MDS patients over 60 years of age with karyotype other than t(15:17),
inv16, t(8:21), who do not want chemotherapy.

3. (Con't from # 2) Patients with MDS who do not want chemotherapy as initial treatment,
or who are not eligible for the treatments of higher priority.

4. Agnogenic myeloid metaplasia - myelofibrosis (MMM)

5. Hypereosinophilic syndrome (HES)

6. Polycythemia vera (PV)

7. Mastocytosis

8. Serum bilirubin less than 2mg%, serum creatinine less than 2mg% unless abnormality is
considered due to hematologic malignancy by investigator.

9. Eastern Cooperative Oncology Group (ECOG) Performance Status < 3

10. Patients must sign an informed consent indicating they are aware of the
investigational nature of this study, in keeping with the policies of the hospital.

11. Women of pregnancy potential must practice an effective method of birth control
during the course of the study, in a manner such that risk of failure is minimized.
Prior to study enrollment, women of childbearing potential (WOCBP) (defined as not
post-menopausal for 12 months or no previous surgical sterilization) must be advised
of the importance of avoiding pregnancy during trial participation and the potential
risk factors for an unintentional pregnancy.

12. Continued from #11: In addition, men enrolled on this study should understand the
risks to any sexual partner of childbearing potential and should practice an
effective method of birth control.Women and men must continue birth control for the
duration of the trial and at least 3 months after the last dose of study drug.

13. Inclusion of women and minorities: As per NIH policy, women and members of minorities
will be included in this protocol as they are referred in the relevant populations.
There are no exclusions of women or minorities based on the study objectives.

14. New York Heart Association (NYHA) Class < 3

15. Ph negative MPD including chronic myelomonocytic leukemia (CMML).

Exclusion Criteria:

1. Pregnant or breast-feeding women are excluded.

2. All WOCBP MUST have a negative pregnancy test prior to first receiving
investigational product. If the pregnancy test is positive, the patient must not
receive investigational product and must not be enrolled in the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Acute Myeloid Leukemia
Agnogenic Myeloid Metaplasia
Hypereosinophilic Syndrome
Leukemia, Myelomonocytic, Chronic
Mastocytosis
Myelodysplastic Syndromes
Myelofibrosis
Polycythemia Vera
Intervention(s)
Drug: Dasatinib (BMS-354825)
Primary Outcome(s)
Participant Response Rate [Time Frame: Baseline to completion of 4 week cycle or until disease progression]
Secondary Outcome(s)
Duration of Response (Survival) [Time Frame: Baseline, once a week for a month, thereafter monthly]
Secondary ID(s)
2004-0817
NCI-2012-01353
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bristol-Myers Squibb
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