Trial Outcomes & Findings for Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation (NCT NCT02634827)
NCT ID: NCT02634827
Last Updated: 2019-08-07
Results Overview
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.
TERMINATED
PHASE2
1 participants
Up to 2 years
2019-08-07
Participant Flow
One (1) patient was accrued from December 2015 to June 2018 at Mayo Clinic. Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Participant milestones
| Measure |
Treatment (Decitabine, Midostaurin)
Patients receive decitabine intravenously (IV) over 1 hour on days 1-5 and midostaurin orally (PO) twice daily (BID) on days 8-21 of courses 1 and 2, and on days 1-28 of each subsequent course. Patients failing to achieve complete response (CR)/complete response with incomplete recovery (CRi)/partial response (PR)/morphologic leukemia-free state by end of course 2 receive midostaurin PO BID on days 1-28. Patients achieving CR/CRi/PR/morphologic leukemia-free state by end of course 8 may continue on current regimen. Patients failing to achieve a CR/CRi/PR/ morphologic leukemia-free state in bone marrow blasts by end of course 8 go to event monitoring. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
The distribution of duration of complete response will be estimated using the method of Kaplan-Meier. If there are a sufficient number of CR/CRi, a landmark analyses may be performed to compare duration of CR/CRi in patients who first achieved a CR/CRi at 2 months vs those who first achieved a CR/CRi at 8 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from registration to death due to any cause, assessed up to 2 yearsPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Estimated using the method of Kaplan-Meier. In addition, the overall survival rate at 1 year after registration will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Overall response rate, estimated by the total number of complete or partial responses (CR, CRi, morphologic leukemia-free state, or PR) divided by the total number of evaluable patients Exact binomial 95% confidence intervals for the true overall response rate will be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from registration to the time of relapse or death due to any cause, assessed up to 2 yearsPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Estimated using the method of Kaplan-Meier. In addition, the progression-free survival rate at 1 year after registration will be reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 1 of course 9Population: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Prognostic and predictive factors including age and FLT3 mutation by ITD vs. TKD vs. both will be assessed. These factors will be summarized and used to help characterize the types of patients accrued to this trial. In addition, differences in the distributions of these risk factors by clinical outcome will be explored (CR/CRi vs. not, OS and disease-free survival). Nonparametric quantitative comparisons by group will be made as appropriate (Fisher's exact or Wilcoxon rank sum). Kaplan-Meier methods and log rank statistics will be used to compare between groups for time to- event measures.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 1 of course 9Population: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
MRD 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 (Decitabine, Midostaurin)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place