An Expanded Access Program for Decitabine in Patients With Myelodysplastic Syndrome (MDS)

• Status: No longer available
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag Farmaceutica Ltda.
• Collaborator: Janssen Korea, Ltd., Korea
• Treatments: Azacitidine; Decitabine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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