Trial · NCT02634827
Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation
NCT02634827, Phase 2, Terminated, Mayo Clinic; results first posted 2019-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation. Trials, record NCT02634827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02634827
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation
- NCT number
- NCT02634827
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, FLT3 Tyrosine Kinase Domain Point Mutation, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
- Interventions
- Decitabine, Laboratory Biomarker Analysis, Midostaurin
- First posted
- 2015-12-18
- Last updated
- 2019-08-07
- Results first posted
- 2019-08-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Complete Responses to Therapy, Where a Success is Defined as a CR or CRi as the Objective Status | Up to 2 years | 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. |
| Secondary | Duration of Complete Response, Defined for All Evaluable Patients Who Have Achieved a CR or CRi as the Date at Which the Patient's Objective Status is First Noted to be a CR or CRi to the Earliest Date Relapse is Documented | Up to 2 year | 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. |
| Secondary | Incidence of Adverse Events, Graded According to the NCI CTCAE Version 4.0 | Up to 2 years | 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. |
| Secondary | OS | Time from registration to death due to any cause, assessed up to 2 years | Estimated using the method of Kaplan-Meier. In addition, the overall survival rate at 1 year after registration will be reported. |
| Secondary | 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 | Up to 2 years | 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. |
| Secondary | PFS | Time from registration to the time of relapse or death due to any cause, assessed up to 2 years | Estimated using the method of Kaplan-Meier. In addition, the progression-free survival rate at 1 year after registration will be reported. |
| Other | FLT3 Mutation by ITD vs. TKD vs. Both, Assessed by Polymerase Chain Reaction (PCR), Western Blot, and Flow Cytometry | Up to day 1 of course 9 | 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. |
| Other | Minimal Residual Disease (MRD) Status, Assessed by PCR for FLT3 Mutation (if FLT3 is Repeated) or Flow Cytometry | Up to day 1 of course 9 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Complete Responses to Therapy, Where a Success is Defined as a CR or CRi as the Objective Status | Up to 2 years | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | ||
| SECONDARY | Duration of Complete Response, Defined for All Evaluable Patients Who Have Achieved a CR or CRi as the Date at Which the Patient's Objective Status is First Noted to be a CR or CRi to the Earliest Date Relapse is Documented | Up to 2 year | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | ||
| SECONDARY | Incidence of Adverse Events, Graded According to the NCI CTCAE Version 4.0 | Up to 2 years | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | ||
| SECONDARY | OS | Time from registration to death due to any cause, assessed up to 2 years | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | ||
| SECONDARY | 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 | Up to 2 years | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | ||
| SECONDARY | PFS | Time from registration to the time of relapse or death due to any cause, assessed up to 2 years | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | ||
| OTHER_PRE_SPECIFIED | FLT3 Mutation by ITD vs. TKD vs. Both, Assessed by Polymerase Chain Reaction (PCR), Western Blot, and Flow Cytometry | Up to day 1 of course 9 | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | ||
| OTHER_PRE_SPECIFIED | Minimal Residual Disease (MRD) Status, Assessed by PCR for FLT3 Mutation (if FLT3 is Repeated) or Flow Cytometry | Up to day 1 of course 9 | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Decitabine, Midostaurin) | 1 | |
| Overall Study | COMPLETED | Treatment (Decitabine, Midostaurin) | 1 | |
| Overall Study | NOT COMPLETED | Treatment (Decitabine, Midostaurin) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Decitabine, Midostaurin) | 0 | 0 |
| Total, other adverse events | Treatment (Decitabine, Midostaurin) | 0 | 0 |
| Total, serious adverse events | Treatment (Decitabine, Midostaurin) | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02634827
GET https://conductscience.org/api/trials/v1/NCT02634827/registered