Trial of Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome - Full Text View

Sponsored by:	Eisai Inc.
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00760084

Purpose

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	Intervention	Phase
Acute Myelogenous Leukemia Myelodysplastic Syndrome	Drug: Decitabine	Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: 5-Aza-2'-deoxycytidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Expanded Access Protocol to Administer Decitabine to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

To generate additional information about the overall safety profile [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To generate safety information of hepatically or renally impaired patients, as appropriate [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	July 2005
Study Completion Date:	February 2008
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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).

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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.
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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760084

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 Medical Research Inc.

More Information

Responsible Party:	Eisai Inc. ( Eisai Medical Services )
Study ID Numbers:	DACO-021
Study First Received:	September 24, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00760084
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Medical Research Inc.:

Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Dacogen
Decitabine

Study placed in the following topic categories:

Myelodysplastic syndromes
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Myelodysplasia
Acute myelogenous leukemia
Leukemia, Myeloid

Decitabine
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Bone Marrow Diseases
Acute myelocytic leukemia

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Pathologic Processes
Disease
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Syndrome
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009