Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)

NCT00255346 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2004-0817NCI-2012-01353
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myelodysplastic Syndromes; Agnogenic Myeloid Metaplasia; Myelofibrosis; Hypereosinophilic Syndrome; Polycythemia Vera; Mastocytosis; Leukemia, Myelomonocytic, Chronic; Acute Myeloid Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Participant Response Rate

  Response Rate is complete response plus partial response (CR+PR) for each disease category. Response Evaluation Criteria are as follows: Systemic Mastocytosis (SM): CR is the improvement of C-Findings, Tryptase \<20, and no organomegaly. PR is the improvement of C-Findings. Acute Myeloid Leukemia (AML)/MDS and CMML: CR is bone marrow blasts \</= 5%, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. PR is bone marrow blasts 6-25% but decreased by \> 50% and absolute neutrophil count, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. Primary Myelofibrosis (PMF): CR is bone marrow blasts \</= 5%, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. CR is PR plus one or more of the following: ANC \>/= 1000, decreased platelets by 50%, hemoglobin increase of 2g/dl or reduction splenomegaly and/or hepatomegaly by 50%. HES/CEL: CR is disappearance of eosinophilia \</= 10%, PR is reduction of eosinophilia by \>/= 50%

  Baseline to completion of 4 week cycle or until disease progression

Secondary Outcomes (1)

• Duration of Response (Survival)

  Baseline, once a week for a month, thereafter monthly, up to 10 years

Study Arms (5)

Acute myeloid leukemia (AML)

EXPERIMENTAL

Dasatinib 70 mg orally twice daily.

Drug: Dasatinib (BMS-354825)

MDS/CMML

EXPERIMENTAL

Dasatinib 70 mg orally twice daily.

Drug: Dasatinib (BMS-354825)

HES/CEL

EXPERIMENTAL

Dasatinib 70 mg orally twice daily.

Drug: Dasatinib (BMS-354825)

Primary myelofibrosis (PMF)

EXPERIMENTAL

Dasatinib 70 mg orally twice daily.

Drug: Dasatinib (BMS-354825)

Systemic Mastocytosis (SM)

EXPERIMENTAL

Dasatinib 70 mg orally twice daily.

Drug: Dasatinib (BMS-354825)

Interventions

Dasatinib (BMS-354825) DRUG

70 mg orally twice daily

Also known as: Sprycel

Acute myeloid leukemia (AML); HES/CEL; MDS/CMML; Primary myelofibrosis (PMF); Systemic Mastocytosis (SM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Complete Response (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.
• New York Heart Association (NYHA) Class \< 3
• Ph negative MPD including chronic myelomonocytic leukemia (CMML).

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Primary Myelofibrosis; Hypereosinophilic Syndrome; Polycythemia Vera; Mastocytosis; Leukemia, Myelomonocytic, Chronic; Leukemia

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Eosinophilia; Leukocyte Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Mast Cell Activation Disorders; Immune System Diseases; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

The outcome measures were collected and reported by participant diagnosis group. The Other Adverse Events and Serious Adverse Events were collected and recorded as a group for all participants registered on the study.

Results Point of Contact

• Title: Hagop Kantarjian, MD/Department Chair
• Organization: The University of Texas MD Anderson Cancer Center

hkantarjian@mdanderson.org

713-792-7026

Study Officials

• Hagop M Kantarjian, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2005
• First Posted: November 18, 2005
• Study Start: November 15, 2005
• Primary Completion: March 3, 2017
• Study Completion: March 3, 2017
• Last Updated: December 30, 2025
• Results First Posted: May 6, 2019

Record last verified: 2025-12

Locations

US (1)