Trial of Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

NCT00760084 | Completed Phase 2 Results

• 1 other identifier: DACO-021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to provide decitabine to patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have completed participation per protocol in the DACO-018 study.

Conditions

Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Keywords

Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Dacogen; Decitabine

Outcome Measures

Primary Outcomes (1)

• The Number of Subjects With Adverse Events

  Generate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m\^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (\< 30% blasts) or AML (\> 30% blasts).

  3 months

Study Arms (1)

A

EXPERIMENTAL

Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.

Drug: Decitabine

Interventions

Decitabine DRUG

Decitabine is administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML; ≥ 30% blasts).

Also known as: Dacogen

A

Eligibility Criteria

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

You may qualify if:

• Must sign an Institutional Review Board (IRB) -approved informed consent form, indicating his/her awareness of the investigational nature of decitabine and its potential hazards prior to initiation of any study-specific procedures or treatment.
• Must have had one of the following:
• MDS (de novo or secondary) fitting any of the recognized French-American-British classifications
• chronic myelomonocytic leukemia (with WBC \<12,000/μL)
• AND
• an International Prognostic Scoring System score of ≥1.5 as determined by complete blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of study entry OR AML (≥ 30 % bone marrow blasts), except M3 or acute promyelocytic leukemia.
• Must be age 18 years or older.
• Must have completed participation per protocol in the MGI PHARMA DACO-018 decitabine trial.
• Must enroll in this trial no more than 8 weeks after discontinuation from the MGI PHARMA DACO-018 trial.
• Must have recovered from all toxic effects of all prior therapy.

You may not qualify if:

• Must not have any other active malignancy, other than basal or squamous cell skin carcinoma.
• Must not have received in the period after discontinuation from DACO-018 and enrollment into this trial any other chemotherapy agent, including investigational agents, for their disease.
• Must not have evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial, at the discretion of the principal investigator.
• Must not be pregnant or lactating.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

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: Yufang Lu, MD, PhD
• Organization: Eisai Inc.

888-422-4743

Study Officials

• Akhil Baranwal, MD

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: July 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: February 1, 2008
• Last Updated: August 8, 2011
• Results First Posted: August 2, 2011

Record last verified: 2011-08

Locations

US (1)