Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01201811
First received: September 13, 2010
Last updated: August 14, 2013
Last verified: August 2013

September 13, 2010
August 14, 2013
October 2010
May 2013   (final data collection date for primary outcome measure)
Proportion of participants with a hematologic response (defined as Complete Response and Partial Response), and Hematologic Improvement based on International Working Group 2000 response criteria for Myelodysplastic Syndromes. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Proportion of participants with a hematologic response (defined as Complete Response and Partial Response), and Hematologic Improvement based on International Working Group 2000 response criteria for Myelodysplastic Syndromes.
Same as current
Complete list of historical versions of study NCT01201811 on ClinicalTrials.gov Archive Site
  • Number of red blood cell transfusions [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Number of platelet transfusions [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Number of infections requiring intravenous antibiotics [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Safety (type, frequency, severity, and relationship of adverse events to azacitidine) [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Steady-state plasma azacitidine concentrations [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)
A Phase 4, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes.

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).

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 undergoing any study-related procedures. Screening procedures are to take place within 28 days prior to the initiation of azacitidine treatment (Day 1, Cycle 1). Subject eligibility will be based on central pathology review. Bone marrow aspirate and bone marrow biopsy will be collected at screening and sent for morphological assessment by a central pathology reviewer prior to the subject receiving IP. The central pathology reviewer will document the MDS classification according to the FAB and WHO criteria (Appendix A and B, respectively).

A standard cytogenetic metaphase preparation will be prepared from the bone marrow aspirate and sent to the local or central laboratory (for sites without local analysis capability) for the cytogenetic analysis prior to receiving IP.

The IPSS score will be calculated using the central reviewer's pathology report for bone marrow blast percentage, local cytogenetic assessment for karyotype, and central laboratory report for number of cytopenias (Appendix D).

Treatment Phase:

The first dose of azacitidine for each subject begins on Day 1 of Cycle 1. All subjects will receive azacitidine 75 mg/m2/day SC for 7 days every 28 days for up to 6 cycles, unless they are discontinued from treatment. Visits during the treatment phase are to be scheduled weekly for the first 2 cycles, then every other week for all subsequent cycles throughout the rest of the study. Safety and efficacy measures are to be performed weekly, every other week, every 4 weeks, or at 24 weeks, depending on the procedure.

Post-Treatment Phase:

All discontinued subjects, regardless of reason for discontinuation, should undergo end-of-study procedures at the time of study discontinuation. Subjects will have a follow-up visit for the collection of adverse events up to 28 days after last IP dose.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelodysplastic Syndromes
Drug: Azacitidine
Subjects will receive azacitidine 75 mg/m2/day SC for 7 days every 28 days for up to 6 cycles, unless they are discontinued from the treatment. In addition, subjects may receive best supportive care as needed, including antibiotics and transfusions, per Investigator discretion.
Experimental: Single-Arm
Azacitidine 75 mg/m^2/day Subcutaneous for 7 days Day every 28 days for up to 6 cycles
Intervention: Drug: Azacitidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
42
September 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01201811
AZA-MDS-001
No
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: C L Beach, PharmD Celgene Corporation
Celgene Corporation
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP