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Trial record 16 of 23 for:    "Bone Marrow Cancer" | "Protein Kinase Inhibitors"

Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00255346
Recruitment Status : Completed
First Posted : November 18, 2005
Results First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE November 16, 2005
First Posted Date  ICMJE November 18, 2005
Results First Submitted Date  ICMJE April 17, 2018
Results First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE November 15, 2005
Actual Primary Completion Date March 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
Participant Response Rate [ Time Frame: Baseline to completion of 4 week cycle or until disease progression ]
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%
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00255346 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
Duration of Response (Survival) [ Time Frame: Baseline, once a week for a month, thereafter monthly, up to 10 years ]
Response date to loss of response or last follow up.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)
Official Title  ICMJE 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)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
  • Agnogenic Myeloid Metaplasia
  • Myelofibrosis
  • Hypereosinophilic Syndrome
  • Polycythemia Vera
  • Mastocytosis
  • Leukemia, Myelomonocytic, Chronic
Intervention  ICMJE Drug: Dasatinib (BMS-354825)
70 mg orally twice daily
Other Name: Sprycel
Study Arms  ICMJE
  • Experimental: Acute myeloid leukemia (AML)
    Dasatinib 70 mg orally twice daily.
    Intervention: Drug: Dasatinib (BMS-354825)
  • Experimental: MDS/CMML
    Dasatinib 70 mg orally twice daily.
    Intervention: Drug: Dasatinib (BMS-354825)
  • Experimental: HES/CEL
    Dasatinib 70 mg orally twice daily.
    Intervention: Drug: Dasatinib (BMS-354825)
  • Experimental: Primary myelofibrosis (PMF)
    Dasatinib 70 mg orally twice daily.
    Intervention: Drug: Dasatinib (BMS-354825)
  • Experimental: Systemic Mastocytosis (SM)
    Dasatinib 70 mg orally twice daily.
    Intervention: Drug: Dasatinib (BMS-354825)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2017)
68
Original Enrollment  ICMJE
 (submitted: November 16, 2005)
120
Actual Study Completion Date  ICMJE March 3, 2017
Actual Primary Completion Date March 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00255346
Other Study ID Numbers  ICMJE 2004-0817
NCI-2012-01353 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Hagop M Kantarjian, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP