Trial Outcomes & Findings for Decitabine (DAC) w/ or w/o Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) (NCT NCT00414310)
NCT ID: NCT00414310
Last Updated: 2019-05-21
Results Overview
Complete Remission (CR): CR defined as normalization of peripheral blood and bone marrow with \< 5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 10\^9/ L, and a platelet count \> 100 x 10\^9/L). CRi or complete remission with incomplete platelet recovery is defined as above, but platelets \<100 x 109/L. Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. Clinical Benefit: In MDS/CMML, as per International Working Group (IWG) criteria, platelets increase by 50% and to above 30 x 10\^9/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 10\^9/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by \> 50%; or monocytosis reduction by \> 50% if pretreatment \> 5 x 10\^9/L. In addition to IWG criteria, in AML, a decrease in bone marrow blasts to \<5% also considered clinical benefit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
1 Year
Results posted on
2019-05-21
Participant Flow
Recruitment Period: 12/13/2006 to 07/05/2010. All recruitment done at The University of Texas MD Anderson Cancer Center.
Of the 153 participants registered on the study for Decitabine (DAC) with or without Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML), three were screen failures therefore 150 patients were randomized with 149 participants treated.
Participant milestones
| Measure |
Decitabine
Decitabine 20 mg/m\^2 intravenous (IV) over 1 hour daily for 5 days.
|
Decitabine + Valproic Acid
Decitabine 20 mg/m\^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
79
|
|
Overall Study
COMPLETED
|
70
|
79
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Decitabine
Decitabine 20 mg/m\^2 intravenous (IV) over 1 hour daily for 5 days.
|
Decitabine + Valproic Acid
Decitabine 20 mg/m\^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
|
|---|---|---|
|
Overall Study
Not treated
|
1
|
0
|
Baseline Characteristics
Decitabine (DAC) w/ or w/o Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Decitabine
n=71 Participants
Decitabine 20 mg/m\^2 intravenous (IV) over 1 hour daily for 5 days.
|
Decitabine + Valproic Acid
n=79 Participants
Decitabine 20 mg/m\^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=39 Participants
|
66 years
n=41 Participants
|
69 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=39 Participants
|
37 Participants
n=41 Participants
|
58 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=39 Participants
|
42 Participants
n=41 Participants
|
92 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=39 Participants
|
79 participants
n=41 Participants
|
150 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 1 YearPopulation: One enrolled participant on the Decitabine arm was not treated, therefore not evaluable for response.
Complete Remission (CR): CR defined as normalization of peripheral blood and bone marrow with \< 5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 10\^9/ L, and a platelet count \> 100 x 10\^9/L). CRi or complete remission with incomplete platelet recovery is defined as above, but platelets \<100 x 109/L. Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. Clinical Benefit: In MDS/CMML, as per International Working Group (IWG) criteria, platelets increase by 50% and to above 30 x 10\^9/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 10\^9/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by \> 50%; or monocytosis reduction by \> 50% if pretreatment \> 5 x 10\^9/L. In addition to IWG criteria, in AML, a decrease in bone marrow blasts to \<5% also considered clinical benefit.
Outcome measures
| Measure |
Decitabine
n=70 Participants
Decitabine 20 mg/m\^2 intravenous (IV) over 1 hour daily for 5 days.
|
Decitabine + Valproic Acid
n=79 Participants
Decitabine 20 mg/m\^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
|
|---|---|---|
|
Participant Response Rates to Decitabine With or Without Valproic Acid in MDS and AML
Complete Remission (CR)
|
22 Percentage of Participants
|
29 Percentage of Participants
|
|
Participant Response Rates to Decitabine With or Without Valproic Acid in MDS and AML
Complete Remission Without Platelet Recovery (CRi)
|
6 Percentage of Participants
|
9 Percentage of Participants
|
|
Participant Response Rates to Decitabine With or Without Valproic Acid in MDS and AML
Partial Remission (PD)
|
0 Percentage of Participants
|
1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: One enrolled participant on the Decitabine arm was not treated, therefore not evaluable for response.
The date of Response to the date of loss of response or last follow-up.
Outcome measures
| Measure |
Decitabine
n=70 Participants
Decitabine 20 mg/m\^2 intravenous (IV) over 1 hour daily for 5 days.
|
Decitabine + Valproic Acid
n=79 Participants
Decitabine 20 mg/m\^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
|
|---|---|---|
|
Response Duration
|
12.9 Months
Interval 1.0 to 55.0
|
6.3 Months
Interval 2.0 to 57.0
|
SECONDARY outcome
Timeframe: Up to 7 yearsPopulation: One enrolled participant on the Decitabine arm was not treated, therefore not evaluable for response.
Time from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Decitabine
n=70 Participants
Decitabine 20 mg/m\^2 intravenous (IV) over 1 hour daily for 5 days.
|
Decitabine + Valproic Acid
n=79 Participants
Decitabine 20 mg/m\^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
|
|---|---|---|
|
Overall Survival Rate
|
11.2 months
Interval 0.0 to 70.0
|
11.9 months
Interval 0.0 to 73.0
|
Adverse Events
Decitabine
Serious events: 43 serious events
Other events: 27 other events
Deaths: 0 deaths
Decitabine + Valproic Acid
Serious events: 49 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Decitabine
n=71 participants at risk
Decitabine 20 mg/m\^2 intravenous (IV) over 1 hour daily for 5 days.
|
Decitabine + Valproic Acid
n=79 participants at risk
Decitabine 20 mg/m\^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Edema
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
2.5%
2/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Blood and lymphatic system disorders
Gastrointestinal Hemorrhage
|
4.2%
3/71 • Number of events 4 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
Atrial flutter
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
bilateral deviationn eye
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
Cardiac Arrhythmia
|
2.8%
2/71 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
2.5%
2/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
cardiac hypotension
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
Cardiac infarction
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
Congestive Heart Failure
|
2.8%
2/71 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
3.8%
3/79 • Number of events 3 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
Hypotension
|
2.8%
2/71 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
Myocardial Infarction
|
2.8%
2/71 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
Pacemaker malfuncion
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
Pulmonary hypertension
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
Pulmonary Obstruction
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
3.8%
3/79 • Number of events 3 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
2.5%
2/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Back Pain
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Death
|
12.7%
9/71 • Number of events 9 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
6.3%
5/79 • Number of events 5 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Fall
|
2.8%
2/71 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Fatigue
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
fever
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
3.8%
3/79 • Number of events 3 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Joint pain
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Tumor lysis syndrome
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
2.5%
2/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Weakness
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Infections and infestations
Bacteremia
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
5.1%
4/79 • Number of events 4 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Infections and infestations
Infection other
|
14.1%
10/71 • Number of events 16 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
11.4%
9/79 • Number of events 9 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Infections and infestations
Neutropenic Fever
|
15.5%
11/71 • Number of events 13 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
27.8%
22/79 • Number of events 34 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Infections and infestations
Pancreatitis
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Infections and infestations
Pneumonia
|
14.1%
10/71 • Number of events 10 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
13.9%
11/79 • Number of events 13 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Altered Mental Status
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Anxiety and Depression
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Ataxia
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Confusion
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
encephalopathy
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Hallucinations
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
5.1%
4/79 • Number of events 4 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Stroke
|
2.8%
2/71 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
visual loss
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Renal and urinary disorders
acute renal failure
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Renal and urinary disorders
Renal Failure
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
2.5%
2/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
2.5%
2/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
2.5%
2/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Surgical and medical procedures
cholecystectomy
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
2.5%
2/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
Other adverse events
| Measure |
Decitabine
n=71 participants at risk
Decitabine 20 mg/m\^2 intravenous (IV) over 1 hour daily for 5 days.
|
Decitabine + Valproic Acid
n=79 participants at risk
Decitabine 20 mg/m\^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Edema: limb
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
Cardiac Arrhythmia
|
2.8%
2/71 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
2.5%
2/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Cardiac disorders
Cardiac General
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Eye disorders
Vision-blurred vision
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
4/71 • Number of events 4 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
5.1%
4/79 • Number of events 4 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
3/71 • Number of events 3 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
12.7%
10/79 • Number of events 12 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
General disorders
Fatigue
|
8.5%
6/71 • Number of events 6 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
11.4%
9/79 • Number of events 9 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
General disorders
Pain
|
4.2%
3/71 • Number of events 3 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
2.5%
2/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Infections and infestations
Cholecystitis
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Infections and infestations
Infection
|
11.3%
8/71 • Number of events 10 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
10.1%
8/79 • Number of events 11 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Infections and infestations
Neutropenic Fever
|
14.1%
10/71 • Number of events 13 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
15.2%
12/79 • Number of events 17 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Infections and infestations
Opportunistic infection
|
2.8%
2/71 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
3.8%
3/79 • Number of events 3 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Metabolism and nutrition disorders
Creatinine
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Metabolism and nutrition disorders
hyperbilirubinemia
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory-Other
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Confusion
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
3.8%
3/79 • Number of events 3 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
6.3%
5/79 • Number of events 5 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Mood alteration
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Neurology Other
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
5.1%
4/79 • Number of events 4 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Sensory Neuropathy
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
0.00%
0/79 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
7.6%
6/79 • Number of events 7 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Renal and urinary disorders
Renal Failure
|
5.6%
4/71 • Number of events 4 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Renal and urinary disorders
Renal Gentitourinary other
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
1.3%
1/79 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
0.00%
0/71 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
2.5%
2/79 • Number of events 2 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
1.4%
1/71 • Number of events 1 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
5.1%
4/79 • Number of events 4 • Adverse events reported during each treatment course every 4-8 weeks and extending 30 days beyond the last day of active treatment. Overall period: 12/2006 to 07/2011.
|
Additional Information
Hagop Kantarjian, MD/Chair, Leukemia Department
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7026
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place