Trial Outcomes & Findings for Phase II Study of Decitabine and Cytarabine for Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) (NCT NCT01829503)
NCT ID: NCT01829503
Last Updated: 2019-11-14
Results Overview
The number of participants who experienced either a Complete Response, Complete Response with Incomplete Count Recovery, Partial Response, or Progressive Disease. Complete response: Less than 5% blasts in an aspirate sample of a patient who has an absolute neutrophil count of \>1000µ/L and platelets \>100,000µ/L; Complete response with incomplete count recovery: Complete response except for residual neutropenia (\<1000µ/L) or thrombocytopenia (\<100,000µ/L) Partial response: Decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate; Progressive disease: Failure to achieve complete response or partial response
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Up to 38 months
Results posted on
2019-11-14
Participant Flow
Participant milestones
| Measure |
Decitabine + Cytarabine
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Decitabine and Cytarabine for Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Decitabine + Cytarabine
n=44 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Age, Continuous
|
76.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Acute myeloid leukemia (AML) Type
AML with MDS Changes
|
24 participants
n=5 Participants
|
|
Acute myeloid leukemia (AML) Type
Primary AML
|
12 participants
n=5 Participants
|
|
Acute myeloid leukemia (AML) Type
Treatment-Related AML
|
8 participants
n=5 Participants
|
|
Baseline ECOG Status
ECOG Status 0
|
7 participants
n=5 Participants
|
|
Baseline ECOG Status
ECOG Status 1
|
24 participants
n=5 Participants
|
|
Baseline ECOG Status
ECOG Status 2
|
13 participants
n=5 Participants
|
|
Charlson comorbidity index
4
|
1 participants
n=5 Participants
|
|
Charlson comorbidity index
5
|
5 participants
n=5 Participants
|
|
Charlson comorbidity index
6
|
20 participants
n=5 Participants
|
|
Charlson comorbidity index
>6
|
18 participants
n=5 Participants
|
|
FLT (FMS-like tyrosine kinase 3) and NPM1 (nucleophosmin) gene Status
Favorable
|
3 participants
n=5 Participants
|
|
FLT (FMS-like tyrosine kinase 3) and NPM1 (nucleophosmin) gene Status
Intermediate-1
|
16 participants
n=5 Participants
|
|
FLT (FMS-like tyrosine kinase 3) and NPM1 (nucleophosmin) gene Status
Intermediate-2
|
3 participants
n=5 Participants
|
|
FLT (FMS-like tyrosine kinase 3) and NPM1 (nucleophosmin) gene Status
Adverse
|
22 participants
n=5 Participants
|
|
FLT and NPM1 Status
FLT3 D835+
|
2 participants
n=5 Participants
|
|
FLT and NPM1 Status
FLT3-/NPM1-
|
3 participants
n=5 Participants
|
|
FLT and NPM1 Status
FLT3-/NPM1+
|
2 participants
n=5 Participants
|
|
FLT and NPM1 Status
FLT3+/NPM1-
|
2 participants
n=5 Participants
|
|
FLT and NPM1 Status
FLT3-+/NPM1+
|
2 participants
n=5 Participants
|
|
FLT and NPM1 Status
No data for FLT3 and NPM1 status
|
33 participants
n=5 Participants
|
|
Albumin
|
3.4 g/dL
n=5 Participants
|
|
Bilirubin
|
0.8 mg/dL
n=5 Participants
|
|
Creatinine
|
0.97 mg/dL
n=5 Participants
|
|
Hematocrit (volume of red blood cells / total volume of blood)
|
27.9 percentage of total blood volume
n=5 Participants
|
|
Lactate dehydrogenase (LDH)
|
233 IU/L
n=5 Participants
|
|
White Blood Cells (WBC)
|
5.25 10^9 white blood cells per liter
n=5 Participants
|
|
Bone marrow blasts (number of blasts/total cells in bone marrow)
|
56.65 percent of total white blood cell count
n=5 Participants
|
|
Peripheral Blood blasts (number of blasts/total white blood cell count)
|
13 percent
n=5 Participants
|
|
Platelets
|
54.5 10^9 cells per liter
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 38 monthsPopulation: Evaluable participants with known Clinical Response.
The number of participants who experienced either a Complete Response, Complete Response with Incomplete Count Recovery, Partial Response, or Progressive Disease. Complete response: Less than 5% blasts in an aspirate sample of a patient who has an absolute neutrophil count of \>1000µ/L and platelets \>100,000µ/L; Complete response with incomplete count recovery: Complete response except for residual neutropenia (\<1000µ/L) or thrombocytopenia (\<100,000µ/L) Partial response: Decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate; Progressive disease: Failure to achieve complete response or partial response
Outcome measures
| Measure |
Decitabine + Cytarabine
n=39 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Number of Participants by Best Clinical Response Experienced
Complete Response
|
20 Participants
|
|
Number of Participants by Best Clinical Response Experienced
Complete Response with Incomplete Count Recovery
|
6 Participants
|
|
Number of Participants by Best Clinical Response Experienced
Partial Response
|
6 Participants
|
|
Number of Participants by Best Clinical Response Experienced
Progressive Disease
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to 38 monthsPopulation: Evaluable participants with known Clinical Response (CR) (Complete Response, Complete Response with Incomplete Count Recovery, or Partial Response), and participants who had Progressive Disease.
The number of participants (out of 39) who experienced Clinical Response as Complete Response, or, Complete Response + Complete Response with Incomplete Count Recovery (exact Clopper-Pearson confidence interval).
Outcome measures
| Measure |
Decitabine + Cytarabine
n=39 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Proportion of Participants With Clinical Response (CR)
Complete
|
0.51 Proportion of participants
Interval 0.37 to 0.65
|
|
Proportion of Participants With Clinical Response (CR)
Complete + Complete with Incomplete Count Recovery
|
0.67 Proportion of participants
Interval 0.52 to 0.79
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: All study participants.
The number of participants (out of 44) experiencing adverse events, with CTCAE Grade ≥ 3 or Adverse Events Grade ≥ 4
Outcome measures
| Measure |
Decitabine + Cytarabine
n=44 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Numbers of Patients (Out of 44) Experiencing Adverse Events With CTCAE Grade ≥ 3 or Adverse Events Grade ≥ 4
Adverse Events Grade ≥ 3
|
44 Participants
|
|
Numbers of Patients (Out of 44) Experiencing Adverse Events With CTCAE Grade ≥ 3 or Adverse Events Grade ≥ 4
Adverse Events Grade ≥ 4
|
41 Participants
|
SECONDARY outcome
Timeframe: Up to one year (4 weeks, 8 weeks, and one year)Population: All study participants.
The proportion of all participants experiencing four and eight-week mortality, or, who were alive at one year.
Outcome measures
| Measure |
Decitabine + Cytarabine
n=44 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Proportion of Participants With Survival to Four and Eight Weeks and One Year
Death Within 4 Weeks
|
0.023 Proportion of participants
Interval 0.0012 to 0.1
|
|
Proportion of Participants With Survival to Four and Eight Weeks and One Year
Death Within 8 Weeks
|
0.091 Proportion of participants
Interval 0.032 to 0.2
|
|
Proportion of Participants With Survival to Four and Eight Weeks and One Year
Alive at One Year
|
0.48 Proportion of participants
Interval 0.35 to 0.61
|
SECONDARY outcome
Timeframe: Up to 38 months (median follow-up = 25.4 months)Population: All study participants.
Outcome measures
| Measure |
Decitabine + Cytarabine
n=44 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Overall Survival (OS)
|
10.8 months
Interval 9.6 to 16.0
|
SECONDARY outcome
Timeframe: Up to 38 months (median follow-up = 25.4 months)Population: Evaluable participants who experienced a Clinical Response (CR) of Complete Response.
Outcome measures
| Measure |
Decitabine + Cytarabine
n=20 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Overall Survival (OS) in Participants Who Experienced Complete Response
|
18.9 months
Interval 13.6 to
Upper bound of CI not reached.
|
SECONDARY outcome
Timeframe: Up to 38 months (median follow-up = 25.4 months)Population: Evaluable participants who experienced a Clinical Response (CR) of Complete Response, or Complete Response with Incomplete Count Recovery.
Outcome measures
| Measure |
Decitabine + Cytarabine
n=26 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Overall Survival (OS) in Participants Who Experienced Complete Response or Complete Response With Incomplete Count Recovery
|
15.7 months
Interval 12.4 to 29.0
|
SECONDARY outcome
Timeframe: Up to 38 months (median follow-up = 25.4 months)Population: Evaluable participants who experienced a Clinical Response (CR) of Complete Response, Complete Response with Incomplete Count Recovery, or, Partial Response.
Outcome measures
| Measure |
Decitabine + Cytarabine
n=32 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Overall Survival (OS) in Participants Who Experienced Complete Response, Complete Response With Incomplete Count Recovery, or Partial Response
|
15.7 months
Interval 10.6 to 21.5
|
SECONDARY outcome
Timeframe: Up to 38 months (median follow-up = 25.4 months)Population: All study participants.
Median number of months of survival per individual demographic characteristics and clinical measures.
Outcome measures
| Measure |
Decitabine + Cytarabine
n=44 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Age ≤ 75 years
|
12.4 months
Interval 10.4 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Age > 75 years
|
9.7 months
Interval 6.9 to 17.0
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Sex - Female
|
11.0 months
Interval 9.6 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Sex - Male
|
10.6 months
Interval 6.5 to 18.9
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
ECOG status 0
|
16.0 months
Interval 7.6 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
ECOG status 1
|
12.6 months
Interval 9.7 to 18.9
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
ECOG status 2
|
4.2 months
Interval 1.9 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Charlson co-morbidity status ≤ 6
|
14.3 months
Interval 10.4 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Charlson co-morbidity status > 6
|
7.4 months
Interval 3.6 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
FLT and NPM1 Status: favorable
|
18.9 months
Interval 6.9 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
FLT and NPM1 Status: intermediate
|
7.6 months
Interval 4.2 to 17.0
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
FLT and NPM1 Status: adverse
|
14.3 months
Interval 10.6 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
AML Type-Primary AML
|
10.3 months
Interval 4.2 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
AML Type-AML with MDS changes
|
11.5 months
Interval 7.6 to 17.0
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
AML Type-Treatment-related AML
|
12.4 months
Interval 6.5 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
WBC ≤ 5.25 µ/L
|
14.9 months
Interval 12.4 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
WBC > 5.25 µ/L
|
7.6 months
Interval 3.6 to 16.0
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Hematocrit ≤ 27.9%
|
13.0 months
Interval 6.9 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Hematocrit > 27.9%
|
10.5 months
Interval 7.6 to 21.5
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Platelets ≤ 54.5 µ/L
|
10.4 months
Interval 5.5 to 16.0
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Platelets > 54.5 µ/L
|
15.4 months
Interval 9.6 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Albumin ≤ 3.4 gm/dL
|
10.8 months
Interval 6.9 to 15.4
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Albumin > 3.4 gm/dL
|
13.6 months
Interval 7.6 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Creatinine ≤ 0.97 mg/dL
|
10.6 months
Interval 9.6 to 17.0
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Creatinine > 0.97 mg/dL
|
14.9 months
Interval 5.5 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Bilirubin ≤ 0.8 mg/dL
|
10.4 months
Interval 5.5 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Bilirubin > 0.8 mg/dL
|
13.6 months
Interval 7.6 to 21.5
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
LDH ≤ 233 IU/L
|
14.4 months
Interval 10.4 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
LDH > 233 IU/L
|
6.9 months
Interval 4.2 to 16.7
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Bone marrow blasts ≤ 53.65%
|
14.9 months
Interval 12.4 to 29.0
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Bone marrow blasts > 53.65%
|
7.6 months
Interval 4.2 to 16.7
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Peripheral blasts ≤ 13%
|
14.0 months
Interval 10.4 to
Upper bound of CI not reached.
|
|
Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)
Peripheral blasts > 13%
|
7.6 months
Interval 4.2 to
Upper bound of CI not reached.
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: Evaluable participants who experienced a Clinical Response (CR) of Complete Response or Complete Response with Incomplete Count Recovery.
Outcome measures
| Measure |
Decitabine + Cytarabine
n=26 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Relapse-Free Survival in Participants With Complete Response or Complete Response With Incomplete Count Recovery.
|
11.7 months
Interval 9.4 to 25.3
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: Evaluable participants who experienced a Clinical Response (CR) of Complete Response, Complete Response with Incomplete Count Recovery, or Partial Response.
Outcome measures
| Measure |
Decitabine + Cytarabine
n=29 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Relapse-Free Survival in Participants With Complete Response, Complete Response With Incomplete Count Recovery or Partial Response, and Received Maintenance Therapy
|
11.5 months
Interval 9.4 to 25.3
|
SECONDARY outcome
Timeframe: Baseline to Post-treatment, up to 5 yearsPopulation: Participants that received at least one cycle of treatment.
The FACT-Leu Health-related Quality of Life (HRQOL) Measure is a 27-item FACT-G scale plus a 17-item leukemia sub-scale. The FACT-G contains uses Likert scale 0-4, with 0 ="not at all" and 4 ="very much". The total score can be 0-108 and includes 7 items related Physical Well-being (PWB), 7 items related to Social Well-being (SWB), 6 items related to Emotional Well-being (EWB) and 7 items related to Functional Well-Being (FWB). Higher scores are better. Responses based on how patients felt in the past 7 days. FACT-Leu uses a Likert scale (0 to 4, with 0= "not at all" and 4= "very much"). The total score for the 17 items can be 0-68. Higher scores are better. The FACT-Leu total is the sum of FACT-G and FACT Leu and ranges from 0-176. Higher scores are better. FACT Trial Outcome Index is derived by adding scores on the PWB and FWB sub-scales to the leukemia sub-scales. The total for this index score is from 0-124. Higher scores are better.
Outcome measures
| Measure |
Decitabine + Cytarabine
n=35 Participants
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days.
|
|---|---|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Baseline FACT-LEU Subscale
|
52.05 units on a scale
Standard Error 1.68
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Baseline FACT Trial Outcome Index
|
92.90 units on a scale
Standard Error 3.60
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Baseline FACT-LEU Total
|
135.40 units on a scale
Standard Error 3.90
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Baseline FACT-G Total
|
83.57 units on a scale
Standard Error 2.44
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Baseline FACT-G - Physical Well-Being
|
22.75 units on a scale
Standard Error 1.12
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Baseline FACT-G - Social Well-Being
|
24.73 units on a scale
Standard Error 0.66
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Baseline FACT-G - Emotional Well-Being
|
17.30 units on a scale
Standard Error 0.77
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Baseline FACT-G - Functional Well-Being
|
17.16 units on a scale
Standard Error 1.26
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Post-treatment LEU Subscale
|
51.78 units on a scale
Standard Error 1.39
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Post-treatment FACT Trial Outcome Index
|
92.50 units on a scale
Standard Error 3.21
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Post-treatment FACT-LEU Total
|
137.26 units on a scale
Standard Error 3.97
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Post-treatment FACT-G Total
|
84.23 units on a scale
Standard Error 2.73
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Post-treatment FACT-G - Physical Well-Being
|
23.20 units on a scale
Standard Error 0.75
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Post-treatment FACT-G - Social Well-Being
|
24.72 units on a scale
Standard Error 0.74
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Post-treatment FACT-G - Emotional Well-Being
|
18.07 units on a scale
Standard Error 0.86
|
|
Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure
Post-treatment FACT-G - Functional Well-Being
|
16.62 units on a scale
Standard Error 1.46
|
Adverse Events
Decitabine + Cytarabine
Serious events: 30 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Decitabine + Cytarabine
n=44 participants at risk
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.8%
3/44
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
2.3%
1/44
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.4%
5/44
|
|
Cardiac disorders
Chest pain - cardiac
|
2.3%
1/44
|
|
Cardiac disorders
Sinus tachycardia
|
2.3%
1/44
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/44
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/44
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.3%
1/44
|
|
General disorders
Death NOS
|
4.5%
2/44
|
|
General disorders
Fever
|
4.5%
2/44
|
|
General disorders
General disorders and administration site conditions
|
2.3%
1/44
|
|
General disorders
Malaise
|
2.3%
1/44
|
|
General disorders
Multi-organ failure
|
2.3%
1/44
|
|
General disorders
Pain
|
2.3%
1/44
|
|
Infections and infestations
Infections and infestations
|
2.3%
1/44
|
|
Infections and infestations
Lung infection
|
2.3%
1/44
|
|
Infections and infestations
Sepsis
|
2.3%
1/44
|
|
Infections and infestations
Skin infection
|
2.3%
1/44
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
1/44
|
|
Injury, poisoning and procedural complications
Fracture
|
2.3%
1/44
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.3%
1/44
|
|
Injury, poisoning and procedural complications
Intraoperative venous injury
|
2.3%
1/44
|
|
Investigations
Creatinine increased
|
4.5%
2/44
|
|
Investigations
INR increased
|
2.3%
1/44
|
|
Investigations
Lymphocyte count decreased
|
2.3%
1/44
|
|
Investigations
Neutrophil count decreased
|
2.3%
1/44
|
|
Investigations
Platelet count decreased
|
2.3%
1/44
|
|
Investigations
White blood cell decreased
|
6.8%
3/44
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/44
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.3%
1/44
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.5%
2/44
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.3%
1/44
|
|
Nervous system disorders
Dizziness
|
2.3%
1/44
|
|
Nervous system disorders
Encephalopathy
|
2.3%
1/44
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.3%
1/44
|
|
Nervous system disorders
Stroke
|
2.3%
1/44
|
|
Nervous system disorders
Syncope
|
2.3%
1/44
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/44
|
|
Renal and urinary disorders
Renal and urinary disorders
|
2.3%
1/44
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
2/44
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.5%
2/44
|
|
Vascular disorders
Hypertension
|
4.5%
2/44
|
|
Vascular disorders
Hypotension
|
2.3%
1/44
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.3%
1/44
|
Other adverse events
| Measure |
Decitabine + Cytarabine
n=44 participants at risk
Participants received decitabine 20mg/m\^2 intravenously (IV) for five days followed by cytarabine 100mg/m\^2 continuous IV infusion over 24 hours for five days
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
11.4%
5/44
|
|
Blood and lymphatic system disorders
Anemia
|
72.7%
32/44
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
77.3%
34/44
|
|
Cardiac disorders
Atrial fibrillation
|
6.8%
3/44
|
|
Cardiac disorders
Sinus bradycardia
|
6.8%
3/44
|
|
Cardiac disorders
Pericardial effusion
|
9.1%
4/44
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
4/44
|
|
Eye disorders
Eye disorders
|
6.8%
3/44
|
|
Gastrointestinal disorders
Abdominal distension
|
6.8%
3/44
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
6.8%
3/44
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
5/44
|
|
Gastrointestinal disorders
Constipation
|
31.8%
14/44
|
|
Gastrointestinal disorders
Nausea
|
36.4%
16/44
|
|
Gastrointestinal disorders
Diarrhea
|
40.9%
18/44
|
|
General disorders
General disorders and administration site conditions
|
13.6%
6/44
|
|
General disorders
Non-cardiac chest pain
|
13.6%
6/44
|
|
General disorders
Pain
|
18.2%
8/44
|
|
General disorders
Chills
|
22.7%
10/44
|
|
General disorders
Fever
|
25.0%
11/44
|
|
General disorders
Fatigue
|
43.2%
19/44
|
|
General disorders
Edema limbs
|
47.7%
21/44
|
|
Infections and infestations
Bronchial infection
|
6.8%
3/44
|
|
Infections and infestations
Enterocolitis infectious
|
6.8%
3/44
|
|
Infections and infestations
Mucosal infection
|
9.1%
4/44
|
|
Infections and infestations
Skin infection
|
9.1%
4/44
|
|
Infections and infestations
Infections and infestations
|
18.2%
8/44
|
|
Infections and infestations
Lung infection
|
38.6%
17/44
|
|
Investigations
Investigations
|
11.4%
5/44
|
|
Investigations
Creatinine increased
|
18.2%
8/44
|
|
Investigations
Activated partial thromboplastin time prolonged
|
22.7%
10/44
|
|
Investigations
Alkaline phosphatase increased
|
22.7%
10/44
|
|
Investigations
Aspartate aminotransferase increased
|
22.7%
10/44
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
11/44
|
|
Investigations
INR increased
|
25.0%
11/44
|
|
Investigations
Blood bilirubin increased
|
31.8%
14/44
|
|
Investigations
Lymphocyte count decreased
|
52.3%
23/44
|
|
Investigations
Neutrophil count decreased
|
56.8%
25/44
|
|
Investigations
White blood cell decreased
|
77.3%
34/44
|
|
Investigations
Platelet count decreased
|
79.5%
35/44
|
|
Metabolism and nutrition disorders
Anorexia
|
6.8%
3/44
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.1%
4/44
|
|
Metabolism and nutrition disorders
Hypernatremia
|
9.1%
4/44
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
15.9%
7/44
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.5%
9/44
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.7%
10/44
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
27.3%
12/44
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
36.4%
16/44
|
|
Metabolism and nutrition disorders
Hypokalemia
|
52.3%
23/44
|
|
Metabolism and nutrition disorders
Hyponatremia
|
56.8%
25/44
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
61.4%
27/44
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
3/44
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
9.1%
4/44
|
|
Nervous system disorders
Dizziness
|
9.1%
4/44
|
|
Nervous system disorders
Headache
|
22.7%
10/44
|
|
Psychiatric disorders
Anxiety
|
6.8%
3/44
|
|
Psychiatric disorders
Depression
|
6.8%
3/44
|
|
Psychiatric disorders
Insomnia
|
11.4%
5/44
|
|
Renal and urinary disorders
Hematuria
|
31.8%
14/44
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
9.1%
4/44
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
11.4%
5/44
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
15.9%
7/44
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
18.2%
8/44
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.5%
9/44
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.5%
9/44
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.8%
14/44
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
34.1%
15/44
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.8%
3/44
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.8%
3/44
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.8%
3/44
|
|
Skin and subcutaneous tissue disorders
Purpura
|
15.9%
7/44
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.9%
7/44
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
15.9%
7/44
|
|
Vascular disorders
Hematoma
|
6.8%
3/44
|
|
Vascular disorders
Hypotension
|
6.8%
3/44
|
|
Vascular disorders
Vascular disorders
|
9.1%
4/44
|
|
Vascular disorders
Hypertension
|
27.3%
12/44
|
Additional Information
Dr. Annie P. Im
University of Pittsburgh Cancer Institute
Phone: 412-623-2393
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place