Status:
COMPLETED
An Efficacy and Safety Study of Decitabine in Participants With Myelodysplastic Syndrome (MDS)
Lead Sponsor:
Johnson & Johnson Taiwan Ltd
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the response rate of decitabine in previously treated and untreated Taiwanese participants with Myelodysplastic Syndrome (MDS - a disease associated with decre...
Detailed Description
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), multi-center (when more than 1 hospital or...
Eligibility Criteria
Inclusion
- Participants with documented pathological (bone marrow, no longer than 30 days before first dosing in study) evidence of Myelodysplastic syndromes (MDS) or of chronic myelomonocytic leukemia (CMML) by World health organisation classification
- Participants with international prognostic scoring system (IPSS) score equal to 0.5 or more (only for participants for whom IPSS is applicable)
- Participants with an Eastern oncology cooperative group (ECOG) performance status of 0-2
- Participants with adequate hepatic (liver) and renal (kidney) function as measured by pre-treatment laboratory criteria within 21 days of starting treatment with decitabine
- Participants must have recovered from toxic effects of previous therapy and not receiving any chemotherapy for a minimum of 4 weeks (6 weeks if the participants has been treated with a nitrosoureas) before to the first dose of study drug
Exclusion
- Participants with a diagnosis of acute myeloid leukemia (AML) (greater than 30 percent bone marrow blasts)
- Participants with AML with multilineage dysplasia (abnormal development or cell growth) following MDS (20-30 percent bone marrow blasts) can be enrolled. For these latter participants an observation period of 1 month is necessary to exclude those participants with rapid progression to full blown AML
- Participants with previous treatment with azacitadine or decitabine or hematopoietic stem cell transplantation less than 1 year prior to study enrollment
- Participants with past history of malignancy and received any treatment for this before malignancy within the last 3 years, except for superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia (CIN) or prostate intraepithelial neoplasia (PIN)
- Participants with known hepatitis B (surface antigen-positive) or active hepatitis C infection
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00744757
Start Date
August 1 2008
End Date
August 1 2012
Last Update
September 9 2013
Active Locations (6)
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1
Changhua, Taiwan
2
Kaohsiung City, Taiwan
3
Taichung, Taiwan
4
Tainan, Taiwan