Know Cancer

forgot password

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)

Phase 2
18 Years
Open (Enrolling)
Acute Myeloid Leukemia, Myelodysplastic Syndromes, Agnogenic Myeloid Metaplasia, Myelofibrosis, Hypereosinophilic Syndrome, Polycythemia Vera, Mastocytosis, Leukemia, Myelomonocytic, Chronic

Thank you

Trial Information

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)

Dasatinib is an experimental anti-cancer drug that is designed to block the function of
BCR-ABL, which is the abnormal protein responsible for causing leukemia in some cells.

If you are found to be eligible to take part in this study, you will take dasatinib by mouth
twice a day. If you have mastocytosis, you will take dasatinib by mouth once a day. A
treatment cycle will be defined as 4 weeks (28 days) + 7 days. You will be instructed to
take dasatinib in the morning (between about 6:00 a.m.-10:00 a.m.) and in the evening
(between about 6:00 p.m.-10:00 p.m.).

Blood tests (about 2 - 3 teaspoons) will be done once a week for a month, then once a month
for 5 years, then once every 6 months (if your doctor thinks it is needed) for the remainder
of your treatment on this study. A bone marrow biopsy will be done after 1-2 months of
therapy to document response.

Dasatinib will be given for as long as you are responding. You will be taken off study if
the disease gets worse or intolerable side effects occur.

This is an investigational study. Dasatinib is authorized for use in research only. A
total of 145 patients will take part in this study. All will be treated at MD Anderson.

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participant Response Rate

Outcome Time Frame:

Baseline to completion of 4 week cycle or until disease progression

Safety Issue:


Principal Investigator

Hagop M Kantarjian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
  • Agnogenic Myeloid Metaplasia
  • Myelofibrosis
  • Hypereosinophilic Syndrome
  • Polycythemia Vera
  • Mastocytosis
  • Leukemia, Myelomonocytic, Chronic
  • targeted therapy
  • leukemia
  • Acute myeloid leukemia (AML)
  • Myelodysplastic syndrome (MDS)
  • Agnogenic myeloid metaplasia - myelofibrosis (MMM)
  • Hypereosinophilic syndrome (HES)
  • Polycythemia vera (PV)
  • Mastocytosis
  • CMML
  • Primary Myelofibrosis
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Chronic
  • Mastocytosis
  • Urticaria Pigmentosa
  • Mastocytoma
  • Metaplasia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Polycythemia
  • Polycythemia Vera
  • Hypereosinophilic Syndrome



The University of Texas M.D. Anderson Cancer Center Houston, Texas