Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure

NCT00113321 | Terminated Phase 2 Results

• 1 other identifier: 2004-0468
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To study if decitabine can help to control Myelodysplastic Syndrome (MDS) in patients who have failed on therapy with azacytidine, the current standard of therapy.

Conditions

Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia

Keywords

Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia; Azacytidine Failure; Decitabine

Outcome Measures

Primary Outcomes (1)

• Overall Response

  Participants with Overall Response, categorized as 'Complete Response' to represent remission or 'No Complete Response' for lack of remission. Response evaluation after completing one course of therapy (8-12 weeks), then bone marrow aspiration to document remission every 1-3 courses.

  Blood tests baseline and after completing 8-12 weeks of therapy

Study Arms (1)

Decitabine

EXPERIMENTAL

20 mg/m2 by vein (IV) over 1 hour daily x 5 days.

Drug: Decitabine

Interventions

Decitabine DRUG

20 mg/m2 IV over 1 hour daily x 5 days.

Also known as: Dacogen®

Decitabine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• MDS and 5% or more marrow blasts, or IPSS risk intermediate 1-2 or high risk; or chronic myelomonocytic leukemia. Patients must have failed therapy with azacytidine.
• Performance status 0-2 (ECOG scale); adequate hepatic (bilirubin \< 2 mg/dl) and renal functions (creatinine \<2mg/dl); New York Heart Association (NYHA)cardiac status III-IV excluded.
• Signed informed consent.
• No prior intensive combination chemotherapy or high-dose ara-C (\>/= 1g/m\*2 per dose). Prior biologic therapies, targeted therapies and single agent chemotherapy allowed.
• 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.

You may not qualify if:

• 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.
• Patients with active and uncontrolled infections.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Eisai Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Hagop Kantarjian, M.D., Professor
• Organization: The University of Texas M. D. Anderson Cancer Center

eharriso@mdanderson.org

713/792-7026

Study Officials

• Hagop Kantarjian, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 7, 2005
• First Posted: June 8, 2005
• Study Start: March 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: August 7, 2012
• Results First Posted: February 21, 2011

Record last verified: 2012-08

Locations

US (1)