NCT01026376

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

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Janssen-Cilag Farmaceutica Ltda. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Myelodysplastic Syndromes (MDS), which includes a diverse group of bone marrow disorders that result in ineffective production of blood cells, frequently occurs in elderly patients. Historically, the available treatments for MDS have been symptomatic and supportive, and have not been shown to be effective in producing sustained improvement in hematopoiesis (production of all types of blood cells ) or in delaying leukemic evolution (leukemia is a serious disease in which too many white blood cells are produced, causing weakness and sometimes death). This project is an open-label (all people involved know the identity of the intervention), multicenter, international single arm, Phase 3b study to provide expanded access to Decitabine for patients with myelodysplastic syndromes (MDS). The purpose of this study is to provide Decitabine to patients with Myelodysplastic syndrome (MDS) according some medical classifications: FAB (French-American-British) subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups, including previously treated and untreated for MDS. The secondary objectives are to evaluate the safety and tolerability of Decitabine, as well as the overall response rate according to the International Working Group (IWG) 2000 and IWG 2006 response criteria, hematologic improvement, cytogenetic response rates (evaluation based on genetic), time to acute myeloid leukemia progression or death (evaluate the length of time that passes prior to onset of leukemia progression and/or death), blood product transfusion requirements per patient (with corresponding dates to collect the number of transfusion independent days), days in the hospital (including reason for hospitalization and the ward within the hospital where the hospitalizations occur) and, optionally, quality of life assessment (EORTC QLQ C-30). 3-day cycle: Decitabine will be administered as a 15mg/m2 administered by continuous infusion over 3 hours repeated every 8 hours for 3 days. 5-day cycle: Another optional schedule could be adopted (at discretion of investigators), Decitabine at a dose of 20mg/m² administered intravenously over 1 hour, once daily for 5 consecutive days, of a 4-week cycle. Treatment may be continued as long as the patient continues to benefit.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	decitabine	Cycles of 15mg/m2 infusion during 3h, 3 times a day, per 3 days
DRUG	decitabine	Cycles of 20mg/m2 infusion during 1h, once a day, per 5 days

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2009-12-04
• Last updated: 2013-04-18

Locations

11 sites across 3 countries: Brazil, Hong Kong, Thailand