Dasatinib as Therapy for Myeloproliferative Disorders (MPDs) - Full Text View

Purpose

The goal of this clinical research study is to learn if dasatinib can help to control myeloproliferative disorders. The safety and tolerability of dasatinib will also be studied.

Condition	Intervention	Phase
Acute Myeloid Leukemia Myelodysplastic Syndromes Agnogenic Myeloid Metaplasia Myelofibrosis Hypereosinophilic Syndrome Polycythemia Vera Mastocytosis Leukemia, Myelomonocytic, Chronic	Drug: Dasatinib (BMS-354825)	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

Genetics Home Reference related topics: PDGFRA-associated chronic eosinophilic leukemia PDGFRB-associated chronic eosinophilic leukemia core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA polycythemia vera primary myelofibrosis

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia Myelodysplastic Syndromes

Drug Information available for: Dasatinib

Genetic and Rare Diseases Information Center resources: Polycythemia Vera Myelodysplastic Syndromes Myelofibrosis Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Chronic Myelomonocytic Leukemia Chronic Myeloproliferative Disorders Hypereosinophilic Syndrome Mastocytosis Myelodysplastic/myeloproliferative Disease

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Participant Response Rate [ Time Frame: Baseline to completion of 4 week cycle or until disease progression ] [ Designated as safety issue: No ]
Response Rate is complete response plus partial response (CR+PR) for each disease category.

Secondary Outcome Measures:

Duration of Response (Survival) [ Time Frame: Baseline, once a week for a month, thereafter monthly ] [ Designated as safety issue: No ]
Response duration is from date of first response until relapse. Survival is from start of therapy. They will be done using the Kaplan-Meier estimators, the log-rank tests and the Cox-proportional hazards models.


Estimated Enrollment:	145
Study Start Date:	November 2005
Estimated Primary Completion Date:	November 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dasatinib Dasatinib 70 mg orally twice daily.	Drug: Dasatinib (BMS-354825) 70 mg orally twice daily Other Name: Sprycel

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients >/= 18 years old who meet the following eligibility criteria
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.
(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.
Agnogenic myeloid metaplasia - myelofibrosis (MMM)
Hypereosinophilic syndrome (HES)
Polycythemia vera (PV)
Mastocytosis
Serum bilirubin less than 2mg%, serum creatinine less than 2mg% unless abnormality is considered due to hematologic malignancy by investigator.
Eastern Cooperative Oncology Group (ECOG) Performance Status < 3
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.
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.
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.
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.
New York Heart Association (NYHA) Class < 3
Ph negative MPD including chronic myelomonocytic leukemia (CMML).

Exclusion Criteria:

Pregnant or breast-feeding women are excluded.
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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255346

Locations


United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Bristol-Myers Squibb

Investigators


Principal Investigator:	Hagop M Kantarjian, MD	M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site


Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00255346 History of Changes
Other Study ID Numbers:	2004-0817 NCI-2012-01353
Study First Received:	November 16, 2005
Last Updated:	July 12, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:


targeted therapy leukemia Acute myeloid leukemia (AML) Myelodysplastic syndrome (MDS) Agnogenic myeloid metaplasia - myelofibrosis (MMM)	Hypereosinophilic syndrome (HES) Polycythemia vera (PV) Mastocytosis CMML

Additional relevant MeSH terms:


Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia Syndrome Myelodysplastic Syndromes Preleukemia Primary Myelofibrosis Polycythemia Polycythemia Vera Myeloproliferative Disorders Metaplasia Mastocytosis Hypereosinophilic Syndrome Leukemia, Myelomonocytic, Chronic Neoplasms by Histologic Type	Neoplasms Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin Diseases Eosinophilia Leukocyte Disorders Myelodysplastic-Myeloproliferative Diseases Dasatinib Antineoplastic Agents Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016