Status:
COMPLETED
Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)
Lead Sponsor:
Celgene
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary purpose of this study is to determine the effectiveness and safety of azacitidine in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome (MDS).
Detailed Description
The study has 3 phases which include the Screening Phase, the Treatment Phase, and the Post-Treatment Phase and outlined as follows: Screening Phase: Subjects will provide informed consent prior to ...
Eligibility Criteria
Inclusion
- A diagnosis of RAEB or RAEB-T according to FAB classification for MDS and with an IPSS score of intermediate-2 or high risk or a diagnosis of myelodysplastic CMML per modified FAB criteria.
- Taiwanese males and females ≥ 18 years of age
- ECOG 0, 1, or 2;
- Adequate hepatic and renal organ function
Exclusion
- Previous treatment with azacitidine or decitabine
- Malignant disease diagnosed within prior 12 months
- Uncorrected red cell folate deficiency or vitamin B12 deficiency
- Diagnosis of metastatic disease
- Malignant hepatic tumors
- Known or suspected hypersensitivity to azacitidine or mannitol
- Prior transplantation or cytotoxic therapy, including azacitidine and chemotherapy, administered to treat MDS
- Treatment with erythropoietin or myeloid growth factors during the 21 days prior to Day 1 of Cycle 1 or androgenic hormones during the 14 days prior to Day 1 of Cycle 1;
- Active HIV or viral hepatitis type B or C
- Treatment with other investigational drugs within the previous 30 days prior to Day 1 of Cycle 1, or ongoing adverse events from previous treatment with investigational drugs, regardless of the time period;
- Pregnant or lactating females
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01201811
Start Date
October 1 2010
End Date
May 1 2013
Last Update
December 5 2019
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Changhua Christian Hospital
Changhua, Taiwan, 500
2
Chiayi Chang Gung Memorial Hospital
Chiayi City, Taiwan, 613
3
Buddhist Tzu Chi General Hospital-Hualien Tzu Chi Medical Center
Hualien City, Taiwan, 970
4
Kaohsiung Medical Hospital University
Kaohsiung City, Taiwan, 807