Trial Outcomes & Findings for Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT01806571)
NCT ID: NCT01806571
Last Updated: 2023-05-31
Results Overview
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Up to 56 days
Results posted on
2023-05-31
Participant Flow
Participant milestones
| Measure |
Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)
INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
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|---|---|
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Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)
n=34 Participants
INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
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|---|---|
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Age, Continuous
|
58.6 years
n=99 Participants
|
|
Sex: Female, Male
Female
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10 Participants
n=99 Participants
|
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Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 56 daysThe proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Outcome measures
| Measure |
Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)
n=34 Participants
INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
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|---|---|
|
Proportion of Complete Responses (CR or CRi) During Induction Therapy
|
0.618 proportion of participants
|
SECONDARY outcome
Timeframe: 35 monthsDisease free survival time is defined for all evaluable patients who have achieved a CR or CRi as the time from registration to relapse or death due to any cause. The distribution of disease-free survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)
n=34 Participants
INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
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|---|---|
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Disease Free Survival(DFS) Rate
|
56.4 percentage of patients
Interval 41.6 to 76.6
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Patients that acheived a complete response.
The distribution of duration of complete response will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)
n=21 Participants
INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
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|---|---|
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Duration of Complete Response
|
NA Months
Interval 30.4 to
Median was not reached.
|
SECONDARY outcome
Timeframe: 35 monthsPopulation: All treated patients
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. This data will be reported in the Adverse Events section of the results.
Outcome measures
| Measure |
Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)
n=34 Participants
INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
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|---|---|
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Incidence of Adverse Events as Assessed by NCI CTCAE Version 4.0
|
34 Participants
|
SECONDARY outcome
Timeframe: 39 MonthsOverall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier(Kaplan E 1958).
Outcome measures
| Measure |
Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)
n=34 Participants
INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
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|---|---|
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Overall Survival(OS) Rate
|
70.6 percentage of patients alive
Interval 55.7 to 87.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineWill be summarized and used to help characterize the types of patients accrued to this trial.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineWill be summarized and used to help characterize the types of patients accrued to this trial.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsMRD status will be correlated with response using Fisher's exact test. In addition, the relationship between MRD status (positive vs. negative) and disease-free survival will be evaluated using landmark analyses.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)
Serious events: 31 serious events
Other events: 34 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)
n=34 participants at risk
INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
|
|---|---|
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Blood and lymphatic system disorders
Febrile neutropenia
|
52.9%
18/34 • Number of events 24 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Cardiac disorders
Atrial flutter
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Cardiac disorders
Heart failure
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Ear and labyrinth disorders
Vertigo
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Jejunal hemorrhage
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Rectal fistula
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Infections and infestations
Anorectal infection
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Infections and infestations
Appendicitis
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Infections and infestations
Catheter related infection
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Infections and infestations
Enterocolitis infectious
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
8.8%
3/34 • Number of events 3 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Infections and infestations
Lung infection
|
11.8%
4/34 • Number of events 4 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Infections and infestations
Sepsis
|
14.7%
5/34 • Number of events 6 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Alanine aminotransferase increased
|
20.6%
7/34 • Number of events 7 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Alkaline phosphatase increased
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Aspartate aminotransferase increased
|
14.7%
5/34 • Number of events 5 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Blood bilirubin increased
|
14.7%
5/34 • Number of events 7 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Ejection fraction decreased
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Lipase increased
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Serum amylase increased
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.8%
3/34 • Number of events 4 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.8%
4/34 • Number of events 5 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Psychiatric disorders
Confusion
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Renal and urinary disorders
Proteinuria
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.8%
3/34 • Number of events 3 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Vascular disorders
Hypertension
|
14.7%
5/34 • Number of events 7 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Vascular disorders
Hypotension
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
Other adverse events
| Measure |
Treatment (Nilotinib, Daunorubicin Hydrochloride, Cytarabine)
n=34 participants at risk
INDUCTION THERAPY: Patients receive daunorubicin hydrochloride IV over 10 minutes on days 1-3, cytarabine IV continuously on days 1-7, and nilotinib PO BID on days 4-14. Patients achieving CR or CRi proceed to consolidation therapy. Patients not achieving a significant decrease in bone marrow recovery or CR/CRi upon bone marrow recovery receive another course of induction therapy. CONSOLIDATION THERAPY: Patients receive cytarabine IV every 12 hours on days 1, 3, and 5, and nilotinib PO BID on days 4-14. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRi proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive nilotinib PO BID on days 1-84. Treatment repeats every 84 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cytarabine: Given IV Daunorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Nilotinib: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
94.1%
32/34 • Number of events 72 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.7%
5/34 • Number of events 5 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Cardiac disorders
Palpitations
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Eye disorders
Eye disorders - Other, specify
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Colitis
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Diarrhea
|
14.7%
5/34 • Number of events 7 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
8.8%
3/34 • Number of events 3 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Mucositis oral
|
14.7%
5/34 • Number of events 7 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Nausea
|
20.6%
7/34 • Number of events 7 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
4/34 • Number of events 4 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
General disorders
Edema face
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
General disorders
Edema limbs
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
General disorders
Fatigue
|
14.7%
5/34 • Number of events 6 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
General disorders
Fever
|
8.8%
3/34 • Number of events 3 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Infections and infestations
Catheter related infection
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Infections and infestations
Lung infection
|
8.8%
3/34 • Number of events 4 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Infections and infestations
Skin infection
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Alanine aminotransferase increased
|
44.1%
15/34 • Number of events 29 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Alkaline phosphatase increased
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Aspartate aminotransferase increased
|
44.1%
15/34 • Number of events 22 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Blood bilirubin increased
|
58.8%
20/34 • Number of events 35 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
CD4 lymphocytes decreased
|
29.4%
10/34 • Number of events 23 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Creatinine increased
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Ejection fraction decreased
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
64.7%
22/34 • Number of events 36 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Lipase increased
|
11.8%
4/34 • Number of events 4 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Lymphocyte count decreased
|
44.1%
15/34 • Number of events 25 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Neutrophil count decreased
|
100.0%
34/34 • Number of events 78 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Platelet count decreased
|
100.0%
34/34 • Number of events 79 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Serum amylase increased
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
Weight loss
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Investigations
White blood cell decreased
|
100.0%
34/34 • Number of events 77 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.8%
3/34 • Number of events 4 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.8%
3/34 • Number of events 3 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
23.5%
8/34 • Number of events 8 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • Number of events 5 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Renal and urinary disorders
Proteinuria
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Reproductive system and breast disorders
Scrotal pain
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.2%
13/34 • Number of events 20 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
73.5%
25/34 • Number of events 35 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.9%
1/34 • Number of events 1 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
|
Vascular disorders
Hypertension
|
5.9%
2/34 • Number of events 2 • Adverse events were collected over 35 months and mortality was collected over 39 months.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place