Trial · NCT01846624
Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT01846624, Phase 2, Terminated, David Iberri; results first posted 2018-09-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia. Trials, record NCT01846624. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01846624
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
- NCT number
- NCT01846624
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- David Iberri
- Conditions
Acute Myeloid Leukemia (AML) With Multilineage Dysplasia Following Myelodysplastic Syndrome, in Adults, AML (Adult) With 11q23 (MLL) Abnormalities, AML (Adult) With Del (5q), AML (Adult) With Inv (16) (p13; q22), AML (Adult) With t (16;16) (p13; q22), AML (Adult) With t (8; 21) (q22; q22), Secondary AML (Adult), Untreated AML (Adult)
- Interventions
- Decitabine, Midostaurin
- First posted
- 2013-05-03
- Last updated
- 2018-09-27
- Results first posted
- 2018-09-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Remission (CR) Rate | Up to 1 year | The complete remission (CR) rate, or complete response rate, is reported as the sum and proportion of participants that achieved CR or CR with incomplete blood count recovery (CRi), within 12 months of starting midostaurin treatment. * Complete remission (CR): Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) \> 1000/μL; platelet count \> 100,000/μL; independence of red cell transfusions. * CR with incomplete recovery (CRi): All CR criteria except for ANC \< 1000/μL or platelet count \< 100,000/μL. * Partial remission (PR): All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. |
| Secondary | Overall Response Rate (ORR) | up to 1 year | Overall response rate (ORR) was assessed as the number and proportion of participants who received midostaurin and achieved a partial response (PR), complete response (CR), or complete response with incomplete blood count recovery (CRi). * Complete remission (CR): Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) \> 1000/μL; platelet count \> 100,000/μL; independence of red cell transfusions. * CR with incomplete recovery (CRi): All CR criteria except for ANC \< 1000/μL or platelet count \< 100,000/μL. * Partial remission (PR): All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. |
| Secondary | Median Duration of Response (DoR) | Up to 1 year | Response was assessed by evaluations conducted every 3 cycles (12 weeks). Once documented as partial response (PR), complete response (CR), or complete response with incomplete blood count recover (CRi), response status was confirmed every 12 weeks. In responding participants, duration of response was assessed from the start of treatment through the last documented response before documented progressive disease or death. The outcome is reported as the median value for duration of response, with full range. * CR: Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; ANC \> 1000/μL; platelet \> 100,000/μL; independence of red cell transfusions. * CRi: All CR criteria except ANC \< 1000/μL or platelet count \< 100,000/μL. * PR: All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; \& decrease of pretreatment bone marrow blast percentage by at least 50%. |
| Secondary | Progression-free Survival (PFS) | Up to 2 years | Progression-free survival (PFS) is reported as the number and proportion of participants who did not receive hematopoietic cell transplantation, and who did not experience disease progression or death for any reason within 2 years after starting midostaurin treatment. Progressive disease: Bone marrow blasts ≥ 5%; or reappearance of blasts in the blood; or development of extramedullary disease. |
| Secondary | Overall Survival (OS) | Up to 2 years | Survival is reported as the number and proportion of participants that received midostaurin who remained alive 2 years after starting midostaurin treatment. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Remission (CR) Rate | Up to 1 year | Only participants that started midostaurin therapy are included in the complete response assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) | up to 1 year | Only participants that started midostaurin therapy are included in the response assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Duration of Response (DoR) | Up to 1 year | Does not include participants who did not achieve a documented clinical response. Participants who withdrew to receive hematopoietic cell transplant (HCT) are censored at the last assessment of response prior to HCT. | weeks | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Up to 2 years | Only participants that started midostaurin therapy, and did not withdraw for hematopoietic cell transplantation, are included in the progression-free survival assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | Up to 2 years | Only participants that started midostaurin therapy are included in the overall survival assessment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Remission (CR) Rate | Decitabine, Then Midostaurin | 8 | Participants | ||
| Overall Response Rate (ORR) | Decitabine, Then Midostaurin | 10 | Participants | ||
| Median Duration of Response (DoR) | Decitabine, Then Midostaurin | 24 | Full Range 12 to 36 | weeks | |
| Progression-free Survival (PFS) | Decitabine, Then Midostaurin | 0 | Participants | ||
| Overall Survival (OS) | Decitabine, Then Midostaurin | 2 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Decitabine, Then Midostaurin | 13 | |
| Overall Study | COMPLETED | Decitabine, Then Midostaurin | 12 | |
| Overall Study | NOT COMPLETED | Decitabine, Then Midostaurin | 1 |
Source ClinicalTrials.gov
Adverse events108
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arrhythmia | Cardiac disorders | Decitabine, Then Midostaurin | 5 | 13 | 5 |
| other | Hypertension | Cardiac disorders | Decitabine, Then Midostaurin | 2 | 13 | 2 |
| other | Hypotension | Cardiac disorders | Decitabine, Then Midostaurin | 1 | 13 | 1 |
| other | Headache | Nervous system disorders | Decitabine, Then Midostaurin | 1 | 13 | 1 |
| other | Hearing loss | Nervous system disorders | Decitabine, Then Midostaurin | 1 | 13 | 1 |
| other | Altered mental status | Nervous system disorders | Decitabine, Then Midostaurin | 2 | 13 | 2 |
| other | Confusion | Nervous system disorders | Decitabine, Then Midostaurin | 1 | 13 | 1 |
| other | Agitation | Nervous system disorders | Decitabine, Then Midostaurin | 1 | 13 | 1 |
| other | Delirium | Nervous system disorders | Decitabine, Then Midostaurin | 1 | 13 | 1 |
| other | Lighted-headed | Nervous system disorders | Decitabine, Then Midostaurin | 1 | 13 | 1 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Decitabine, Then Midostaurin | 11 | 13 |
| Total, other adverse events | Decitabine, Then Midostaurin | 13 | 13 |
| Total, serious adverse events | Decitabine, Then Midostaurin | 13 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19880497 | BACKGROUND |
Source PubMed
Grants0
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.
None in this release.
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/NCT01846624
GET https://conductscience.org/api/trials/v1/NCT01846624/events?page=2