NCT01026376

Brief Summary

The purpose of this study is to provide Decitabine to patients with Myelodysplastic syndrome (MDS) of all FAB (French-American-British) subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups, including both previously treated and untreated patients.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2008

Typical duration for all trials

Geographic Reach
3 countries

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

3.4 years

First QC Date

December 3, 2009

Last Update Submit

April 17, 2013

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic SyndromesDecitabine

Interventions

decitabineDRUG

Cycles of 15mg/m2 infusion during 3h, 3 times a day, per 3 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have a diagnosis of MDS (de novo / primary or secondary) of all FAB subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups
  • Has an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2
  • Adequate hepatic and renal function as measured by the following pre-treatment laboratory criteria within 21 days of starting treatment with Decitabine (laboratory measure of liver function no more than 2.5 times the upper limit of normal, laboratory measure of total bilirubin and serum creatinine no more than 1.5 times the upper limit of normal)
  • Female patients must be postmenopausal, or surgically sterile, or abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study
  • Have a negative serum or urine pregnancy test at screening
  • Male subjects should be advised not father a child while on or within 2 months of completion of Decitabine therapy

You may not qualify if:

  • Have a diagnosis of AML (\>20% bone marrow blasts) or other progressive malignant disease
  • has previously been treated with Azacitidine or Decitabine
  • Have uncontrolled heart disease or uncontrolled congestive heart failure
  • Have uncontrolled restrictive or obstructive pulmonary disease
  • Have active viral or bacterial infection
  • Have known positive serology for HIV
  • Have a mental illness or any other condition that could prevent full cooperation with the treatment and monitoring requirements of the study
  • Have known hypersensitivity to any of the excipients of decitabine
  • Are pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Belo Horizonte, Brazil

Location

Unknown Facility

Botucatu, Brazil

Location

Unknown Facility

Brasília, Brazil

Location

Unknown Facility

Campinas, Brazil

Location

Unknown Facility

Fortaleza, Brazil

Location

Unknown Facility

Pinheiros, Brazil

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

São Paulol, Brazil

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Bangkok, Thailand

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Janssen-Cilag Farmaceutica Ltda. Clinical Trial

    Janssen-Cilag Farmaceutica Ltda.

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Study Start

June 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

April 18, 2013

Record last verified: 2013-04

Locations

TH(1)BR(9)HK(1)