|
Main
|
|
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:
|
10 December 2012 |
|
Main ID: |
NCT00255346 |
|
Date of registration:
|
16/11/2005 |
|
Primary sponsor: |
|
|
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
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Hagop M Kantarjian, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
M.D. Anderson Cancer Center |
| | |
|
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. 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. 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)
|
|
Patient 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
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|