Trial Outcomes & Findings for Trial of Decitabine in Patients With Acute Myeloid Leukemia (NCT NCT00260832)
NCT ID: NCT00260832
Last Updated: 2019-09-11
Results Overview
The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
485 participants
Primary outcome timeframe
The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
Results posted on
2019-09-11
Participant Flow
This study was recruited at 65 centers in 12 countries during the period of 2006 to 2009.
Prior to randomization, subjects indicated their preference for treatment, with physician's advice, or either cytarabine or supportive care in the event they were randomized to Arm A.
Participant milestones
| Measure |
Cytarabine or Supportive Care
Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
|
Dacogen (Decitabine) Only
20 mg/m\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
243
|
242
|
|
Overall Study
COMPLETED
|
15
|
31
|
|
Overall Study
NOT COMPLETED
|
228
|
211
|
Reasons for withdrawal
| Measure |
Cytarabine or Supportive Care
Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
|
Dacogen (Decitabine) Only
20 mg/m\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
26
|
19
|
|
Overall Study
Progression
|
116
|
96
|
|
Overall Study
Withdrawal by Subject
|
15
|
17
|
|
Overall Study
Physician Decision
|
15
|
9
|
|
Overall Study
Death
|
43
|
62
|
|
Overall Study
Other
|
10
|
7
|
|
Overall Study
Protocol Violation
|
3
|
1
|
Baseline Characteristics
Trial of Decitabine in Patients With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Cytarabine or Supportive Care
n=243 Participants
Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
|
Dacogen (Decitabine) Only
n=242 Participants
20 mg/m\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
|
Total
n=485 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.53 years
STANDARD_DEVIATION 5.67 • n=5 Participants
|
73.14 years
STANDARD_DEVIATION 5.24 • n=7 Participants
|
73.34 years
STANDARD_DEVIATION 5.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
213 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
422 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.Population: The primary population for all efficacy analyses was the Intent-to-treat (ITT) population defined as all subjects randomly allocated to a treatment arm.
The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
Outcome measures
| Measure |
Cytarabine or Supportive Care
n=243 Participants
Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
|
Dacogen (Decitabine) Only
n=242 Participants
20 mg/m\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
|
|---|---|---|
|
Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.
|
5.0 months
Interval 4.3 to 6.3
|
7.7 months
Interval 6.2 to 9.2
|
SECONDARY outcome
Timeframe: Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)Population: The primary population for all efficacy analyses was the ITT population defined as all participant randomly allocated to a treatment arm.
Morphologic CR plus CRp rate where Morphologic leukemia-free state defined as less that (\<) 5 percent (%) blasts in an aspirate sample with marrow spicules and a count of greater than or equal to (\>=) 200 nucleated cells (there should have been no blasts with Auer rods or persistence of extramedullary disease) plus absolute neutrophil count (ANC) greater than (\>)1,000 per microliter (/mcL), platelet count of \>=100,000/mcL, and the participant must have been independent of transfusions for at least 1 week before each assessment. There was no duration requirement for confirmation of this designation and Morphologic CR without the requirement of platelet count \>=100,000/mcL.
Outcome measures
| Measure |
Cytarabine or Supportive Care
n=243 Participants
Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
|
Dacogen (Decitabine) Only
n=242 Participants
20 mg/m\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
|
|---|---|---|
|
Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)
|
7.8 percentage of participants
|
17.8 percentage of participants
|
Adverse Events
Cytarabine or Supportive Care
Serious events: 162 serious events
Other events: 231 other events
Deaths: 0 deaths
Dacogen (Decitabine) Only
Serious events: 190 serious events
Other events: 237 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cytarabine or Supportive Care
n=237 participants at risk
Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
|
Dacogen (Decitabine) Only
n=238 participants at risk
20 mg/m\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
15.2%
36/237
|
20.2%
48/238
|
|
Infections and infestations
Sepsis
|
4.2%
10/237
|
6.3%
15/238
|
|
Infections and infestations
Septic Shock
|
3.4%
8/237
|
6.3%
15/238
|
|
Infections and infestations
Bronchopneumonia
|
5.1%
12/237
|
3.8%
9/238
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
13.9%
33/237
|
23.9%
57/238
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.6%
11/237
|
8.8%
21/238
|
|
Blood and lymphatic system disorders
Anemia
|
5.1%
12/237
|
6.3%
15/238
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.0%
7/237
|
6.3%
15/238
|
|
General disorders
Disease Progression
|
13.1%
31/237
|
11.3%
27/238
|
|
General disorders
Pyrexia
|
8.4%
20/237
|
9.7%
23/238
|
|
General disorders
General Physical Health Deterioration
|
5.9%
14/237
|
6.3%
15/238
|
|
Cardiac disorders
Atrial Fibrillation
|
4.2%
10/237
|
1.7%
4/238
|
Other adverse events
| Measure |
Cytarabine or Supportive Care
n=237 participants at risk
Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
|
Dacogen (Decitabine) Only
n=238 participants at risk
20 mg/m\^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
|
|---|---|---|
|
General disorders
Pyrexia
|
37.1%
88/237
|
47.9%
114/238
|
|
General disorders
Disease Progression
|
24.9%
59/237
|
23.1%
55/238
|
|
General disorders
Peripheral Edema
|
17.7%
42/237
|
21.0%
50/238
|
|
Infections and infestations
Pneumonia
|
21.1%
50/237
|
24.4%
58/238
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
14/237
|
14.7%
35/238
|
|
Infections and infestations
Oral Herpes
|
6.8%
16/237
|
10.5%
25/238
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
36.3%
86/237
|
44.5%
106/238
|
|
Blood and lymphatic system disorders
Anemia
|
30.8%
73/237
|
40.8%
97/238
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
22.8%
54/237
|
33.2%
79/238
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place