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

• ClinicalTrials.gov Identifier: NCT00760084
• Recruitment Status: Completed
• First Posted: September 25, 2008
• Results First Posted: August 2, 2011
• Last Update Posted: August 8, 2011
• Sponsor: Eisai Inc.
• Information provided by: Eisai Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Myelogenous Leukemia; Myelodysplastic Syndrome	Drug: Decitabine	Phase 2

Detailed Description:

The objectives of this trial are:

• To generate additional information about the overall safety profile,
• To generate safety information of hepatically or renally impaired patients, as appropriate, and
• To generate safety information when patients are also taking concomitant medications and/or therapies without trial restrictions when 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 MDS or AML (≥ 30% blasts).

The purpose of this open-label, expanded-access trial is to provide decitabine to patients with AML or MDS who have completed participation per protocol in the DACO-018 study and for whom continuation of treatment with decitabine is indicated, per the opinion of the investigator. In order to continue treatment with decitabine, at a minimum, there must be no disease progression while the patient was participating in the DACO-018 trial and during the period after the patient discontinued from the DACO-018 study and before entering this trial. Patients must enroll in this trial within 8 weeks of discontinuing from the DACO-018 study and not have received any other chemotherapy for their disease during this interim period.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Expanded Access Protocol to Administer Decitabine to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
• Study Start Date: July 2005
• Actual Primary Completion Date: September 2005
• Actual Study Completion Date: February 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; 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; 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).; Other Name: Dacogen

Outcome Measures

Primary Outcome Measures :

1. The Number of Subjects With Adverse Events [ Time Frame: 3 months ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. 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.

2. Must have had one of the following:

   MDS (de novo or secondary) fitting any of the recognized French-American-British classifications

   OR

   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.

3. Must be age 18 years or older.
4. Must have completed participation per protocol in the MGI PHARMA DACO-018 decitabine trial.
5. Must enroll in this trial no more than 8 weeks after discontinuation from the MGI PHARMA DACO-018 trial.
6. Must have recovered from all toxic effects of all prior therapy.

Exclusion Criteria:

1. Must not have any other active malignancy, other than basal or squamous cell skin carcinoma.
2. 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.
3. 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.
4. Must not be pregnant or lactating.

Contacts and Locations

Locations

United States, Missouri

Washington University School of Medicine

St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Eisai Inc.

Investigators

• Study Director: Akhil Baranwal, MD; Eisai Inc.

More Information

• Responsible Party: Eisai Medical Services, Eisai Inc.
• ClinicalTrials.gov Identifier: NCT00760084
• Other Study ID Numbers: DACO-021
• First Posted: September 25, 2008
• Results First Posted: August 2, 2011
• Last Update Posted: August 8, 2011
• Last Verified: August 2011

Keywords provided by Eisai Inc.:

Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Dacogen; Decitabine

Additional relevant MeSH terms:

Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Syndrome; Disease; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Decitabine; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Enzyme Inhibitors