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Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)

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: NCT00067808
Recruitment Status : Completed
First Posted : August 28, 2003
Results First Posted : May 26, 2011
Last Update Posted : August 7, 2012
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if decitabine (given at 3 different doses) can help to control Myelodysplastic Syndrome (MDS). The safety of these 3 treatments will also be studied.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia Drug: Decitabine Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Randomized Study of Three Different Schedules of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) in Myelodysplastic Syndrome (MDS)
Study Start Date : October 2003
Primary Completion Date : May 2009
Study Completion Date : May 2009


Arm Intervention/treatment
Active Comparator: Decitabine 10 mg/m^2 IV
10 mg/m^2 intravenous (IV) over 1 hour daily for 10 days
Drug: Decitabine
10 mg/m^2 by vein over 1 hour daily for 10 days
Other Name: Dacogen
Active Comparator: Decitabine 20 mg/m2 IV
20 mg/m2 IV over 1 hour daily for 5 days
Drug: Decitabine
20 mg/m2 by vein (IV) over 1 hour daily x 5 days
Other Name: Dacogen
Active Comparator: Decitabine 20 mg/m2 SQ
20 mg/m2 subcutaneous (SQ) daily for 5 days
Drug: Decitabine
20 mg/m2 subcutaneous (SQ) daily x 5 days
Other Name: Dacogen



Primary Outcome Measures :
  1. Participant Responses [ Time Frame: Response to treatment after 8 weeks of therapy ]
    Objective responses by International Working Group criteria: 'Complete Response' (CR) defined as Normalization of the peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 109/ L, and a platelet count > 100 x 109/L); 'Other Response' including Partial Remission (PR) defined as above, except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment combined with participants who meet all criteria for CR except for platelet recovery to >100 x 109/L; and 'No Response'.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. MDS and 5% or more marrow blasts, or IPSS risk intermediate 1-2 or high risk; or chronic myelomonocytic leukemia
  2. Performance status 0-2 (Eastern Cooperative Oncology Group (ECOG) scale); adequate hepatic (bilirubin < 2 mg/dl) and renal functions (creatinine <2mg/dl); New York Heart Association (NYHA) cardiac status III-IV excluded.
  3. Signed informed consent
  4. No prior intensive combination chemotherapy or high-dose ara-C (>/= 1g/m2 per dose). Prior biologic therapies, targeted therapies and single agent chemotherapy allowed.
  5. Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. Use of Hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy.

Exclusion Criteria:

  1. Nursing and pregnant females are excluded. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  2. Patients with active and uncontrolled infections
  3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067808


Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eisai Inc.
Investigators
Principal Investigator: Hagop M Kantarjian, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00067808     History of Changes
Other Study ID Numbers: ID03-0180
First Posted: August 28, 2003    Key Record Dates
Results First Posted: May 26, 2011
Last Update Posted: August 7, 2012
Last Verified: August 2012

Keywords provided by M.D. Anderson Cancer Center:
Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
MDS
Decitabine
Dacogen
Methylation

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Myelodysplastic-Myeloproliferative Diseases
Decitabine
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors