Trial Outcomes & Findings for Decitabine and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, or Myeloproliferative Neoplasm (NCT NCT02121418)
NCT ID: NCT02121418
Last Updated: 2018-04-13
Results Overview
Compared to historical data of a completed Southwestern Oncology Group (SWOG) trial of azacitidine and gemtuzumab ozogamicin.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
At 6 months
Results posted on
2018-04-13
Participant Flow
Participant milestones
| Measure |
Treatment (Decitabine, Cytarabine)
Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Decitabine and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, or Myeloproliferative Neoplasm
Baseline characteristics by cohort
| Measure |
Treatment (Decitabine, Cytarabine)
n=12 Participants
Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsCompared to historical data of a completed Southwestern Oncology Group (SWOG) trial of azacitidine and gemtuzumab ozogamicin.
Outcome measures
| Measure |
Treatment (Decitabine, Cytarabine)
n=12 Participants
Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
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|---|---|
|
Overall Survival of Patients Over Age 60 With Newly Diagnosed AML/High Risk MDS
|
7 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsRate of Complete Response or Complete Response with Incomplete Count Recovery
Outcome measures
| Measure |
Treatment (Decitabine, Cytarabine)
n=12 Participants
Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
|
|---|---|
|
Response Rate
Complete Respnose
|
4 participants
|
|
Response Rate
Complete Response with Incomplete Count Recovery
|
3 participants
|
Adverse Events
Treatment (Decitabine, Cytarabine)
Serious events: 11 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Treatment (Decitabine, Cytarabine)
n=12 participants at risk
Patients receive decitabine IV daily on days 1-10 and cytarabine IV QD on days 1-7. Treatment repeats every 28-35 days for 2 courses in the absence of disease progression or unacceptable toxicity. After course 3, patients achieving remission will receive 1-2 more courses of therapy at the same dose. Patients in remission with significant side effects will receive decitabine and cytarabine at decreased doses. Patients not achieving remission will not receive any more treatment. 12 patients were consented and treated.
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|---|---|
|
Infections and infestations
Febrile Neutropenia
|
33.3%
4/12 • Number of events 5 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Infections and infestations
Pneumonia
|
50.0%
6/12 • Number of events 6 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Infections and infestations
MRSA Bacteremia
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Investigations
Hyponatremia
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Blood and lymphatic system disorders
Hypertension
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Infections and infestations
Staph Bacteremia
|
16.7%
2/12 • Number of events 2 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Investigations
Hypokalemia
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Skin and subcutaneous tissue disorders
Right cheek cellulitis
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Hepatobiliary disorders
Bacterial Liver Abscess
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Infections and infestations
Bacteremia
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
16.7%
2/12 • Number of events 2 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Cardiac disorders
Syncope
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Infections and infestations
C. Difficile Diarrhea
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Infections and infestations
Pyomyositis of B/L calf
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Cardiac disorders
Afibrillation
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Musculoskeletal and connective tissue disorders
Hypoxia
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Investigations
Hyperbilirubinemia
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Gastrointestinal disorders
Esophagogastric mucosal junction ulcer
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Infections and infestations
Clostridium Ramosum bacteremia
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Infections and infestations
Rothia Bacteremia
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Infections and infestations
Oral mucositis
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
|
Infections and infestations
Diverticulitis
|
8.3%
1/12 • Number of events 1 • 2 years
Other \[not including serious\] adverse events were not addressed.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place