An Efficacy and Safety Study of Decitabine in Participants With Myelodysplastic Syndrome (MDS)
|ClinicalTrials.gov Identifier: NCT00744757|
Recruitment Status : Completed
First Posted : September 1, 2008
Results First Posted : August 15, 2013
Last Update Posted : September 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome||Drug: Decitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Multi-center Study of 5-AZA-2'-Deoxycytidine (Decitabine) Single Agent in Taiwanese Patients With Myelodysplastic Syndrome (MDS)|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||August 2012|
Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
Decitabine 20 mg per m^2 will be administered intravenous infusion over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
- Percentage of Participants With Response [ Time Frame: Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal) ]Percentage of participants with response: complete response (CR) or partial response (PR) according to International Working Group (IWG) 2006 criteria was evaluated. CR in bone marrow is defined as<=to 5% myeloblasts with normal maturation of all cell lines and persistent dysplasia was noted in peripheral blood hemoglobin >=11 gram (g) per deciliter (dl), platelets >=100*10^9 liter (l), neutrophils >=1.0*10^9 l, Blasts 0%. Partial response is defined as all CR criteria if abnormal before treatment except: bone marrow blasts decreased by >=50% over pre-treatment but still >=5%.
- Percentage of Participants With Hematologic Treatment Response [ Time Frame: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7 and 8, each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal) ]Hematologic treatment response was assessed as per IWG 2006 criteria. This is measured in erythroid(HI-E), platelet(HI-P) and neutrophil(HI-N) lineages. HI-E response(pre-treatment<11 gram per deciliter [g/dl]):hemoglobin increase by>=1.5 g/dl and relevant reduction in RBC transfusions by 4 RBC transfusions/8week. HI-P response (pre-treatment<100*109/l):absolute increase of >=30*10^9/l for participants starting with>20*10^9/l and increase from <20*10^9/l to>20*10^9/l and by at least 100%. HI-N response (pre-treatment<1.0*10^9/l): at least 100% increase and an absolute increase >0.5*10^9/l.
- Percentage of Participants With Cytogenetic Response [ Time Frame: Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal) ]Cytogenetic responses was assessed as per IWG 2006 criteria which define complete response as disappearance of the chromosomal abnormality without appearance of new ones and partial response as at least 50 percent reduction of the chromosomal abnormality.
- Time to Acute Myeloid Leukemia (AML) Progression or Death [ Time Frame: Start of treatment until disease progression or death (whichever occur first) or up to 736 days ]Time to AML is defined as greater than 30 percent of blasts in bone marrow or the time to death was calculated from the date of treatment start until disease progression to AML or until death, which ever occurred first. Participants who were still alive and did not progress to AML were censored at the moment of last visit.
- Overall Survival [ Time Frame: Start of treatment until disease progression or death (whichever occur first) or up to 736 days ]Overall survival was defined as the time from the date of treatment start until death (whatever the cause). It was calculated from Kaplan-Meier estimates. Participants still alive were censored at the moment of last visit or contact.
- Percentage of Participants With Transfusion Dependency [ Time Frame: 8 weeks before first dose until disease progression or death (whichever occur first) or up to 736 days ]Transfusion requirements for both red blood cells as well as platelets were recorded for each participant.
- Percentage of Participants With Transfusion Independency [ Time Frame: 8 weeks before first dose and 736 days of treatment ]Transfusion independent participants were calculated from all the participants who required transfusion in the duration of 8 weeks before first dose until disease progression or death or up to 736 days. Transfusion independence was defined as lack of requirement for transfusions for at least 8 weeks.
- Duration for Hospitalization [ Time Frame: Cycle 1 up to Cycle 8, each cycle of 28 days. ]Duration of hospitalization was calculated for each participant, using the sum of all hospital days by subtracting the date of discharge from the date of admission.
- Number of Events Which Led to Hospitalization [ Time Frame: Start of treatment until disease progression or death or up to Cycle 8, each cycle of 28 days ]The events (reasons) for hospitalizations such as infection, transfusion, acute choleycystitis, allergic transfusion reaction, dyspnoea with right pleural effusion, febrile neutropenia, fever, for decitabine, Myelodysplastic Syndrome (MDS) hematuria, paronychia, pneumonia, heart failure, peri-anal abscess (PAA), pancytopenia,fluctuated neutropenia fever, right dorsal foot cellulitis, Right lower (Rt.Lw) lung pneumonia with impending respiratory (resp) failure, Serious adverse event (SAE)+schedule hospitalization for decitabine, septic shock and not available were reported.
- Quality of Life Assessment [ Time Frame: Day 1 of Cycle 1 and Cycle 8 (each cycle of 28 days) ]The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1=Not at All' to 4=Very Much') and 2 questions: Q29 on overall health and Q30 on overall quality of life uses 7-point scale ranging from 1=Very Poor to 7=Excellent. Higher score indicates better quality of life.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744757
|Tau-Yuan County 333, Taiwan|
|Study Director:||Johnson & Johnson Taiwan, Ltd. Clinical Trial||Johnson & Johnson Taiwan Ltd|