Trial · NCT01802333
Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia
NCT01802333, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2018-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia. Trials, record NCT01802333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01802333
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia
- NCT number
- NCT01802333
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 754 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
- Interventions
- Allogeneic Hematopoietic Stem Cell Transplantation, Cytarabine, Daunorubicin Hydrochloride, Idarubicin, Laboratory Biomarker Analysis, Vorinostat
- First posted
- 2013-03-01
- Last updated
- 2018-12-19
- Results first posted
- 2018-12-19
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) | EFS assessed for up to 5 years, 2 year EFS reported | EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi. 2-year EFS by arm will be estimated using the Kaplan-Meier method. EFS will be compared between Arm I and Arm III and between Arm II and Arm III using Cox proportional hazards regression. |
| Primary | Rate of Allogeneic HCT | Up to 5 years | The goal of the transplant objective is to determine whether it is possible to conduct allogeneic HCT on 60% or more of adults with high-risk AML in first complete remission (alternative). If 40% or fewer of high-risk patients in CR can be transplanted, the proposed transplant support system will not be considered feasible. A one-sided binomial test compared to the null transplant rate will be conducted. |
| Secondary | Disease-free Survival (DFS) Among High Risk Patients | DFS assessed for up to 5 years, 2 year DFS reported | DFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery). DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. 2-year DFS for high risk patients will be estimated using the Kaplan-Meier method. |
| Secondary | EFS of Arm I Compared to Arm II | EFS assessed for up to 5 years, 2 year EFS reported | EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi. A two-sided test of the hazard ratio (HR) of 7:3: IA (versus the null hypothesis of HR =1) will be done using a proportional hazards regression model with the stratification factors included as covariates. 2-year EFS by arm will be estimated using the Kaplan-Meier method. |
| Secondary | Frequency and Severity of Toxicities | Up to 5 years | Number of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event. |
| Other | Prevalence of the Mutation NPM1 in Patients on This Study. | Baseline | To estimate the prevalence of the mutation NPM1 in this patient population. |
| Other | Prevalence of the Mutations IDH1, IDH2, TET2, DMT3A in Patients on This Study | Baseline | To estimate the prevalence of these mutations in this patient population. This objective will be analyzed as funding allows. |
| Other | Cytogenetic Risk Distribution of Patients on This Study | Baseline | To estimate the cytogenetic risk distribution of patients on this study. |
| Other | Overall Survival (OS) | OS assessed for up to 5 years, 2 year OS reported | To compare OS between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. OS is calculated for all patients from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. 2-year OS by arm will be estimated using the Kaplan-Meier method. |
| Other | Complete Response (CR) Rate | Up to 5 years | To compare the complete response rate between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat. Complete response is defined as: ANC \>= 1,000/mcl, platelet count \>= 100,000/mcl, \< 5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease (no requirements for marrow cellularity or hemoglobin concentration) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival (EFS) | EFS assessed for up to 5 years, 2 year EFS reported | Eligible patients | Proportion of participants | NUMBER |
| PRIMARY | Rate of Allogeneic HCT | Up to 5 years | Eligible patients with high-risk AML who achieved CR or CRi, regardless of treatment arm. | percentage of patients | NUMBER |
| SECONDARY | Disease-free Survival (DFS) Among High Risk Patients | DFS assessed for up to 5 years, 2 year DFS reported | Eligible, high risk patients, regardless of treatment arm. | Proportion of participants | NUMBER |
| SECONDARY | EFS of Arm I Compared to Arm II | EFS assessed for up to 5 years, 2 year EFS reported | Eligible patients | Proportion of participants | NUMBER |
| SECONDARY | Frequency and Severity of Toxicities | Up to 5 years | Eligible patients who started treatment | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Prevalence of the Mutation NPM1 in Patients on This Study. | Baseline | Eligible patients with known NPM1 status at baseline | percentage of patients | NUMBER |
| OTHER_PRE_SPECIFIED | Prevalence of the Mutations IDH1, IDH2, TET2, DMT3A in Patients on This Study | Baseline | There was not sufficient funding to test patients for IDH1, IDH2, TET2, or DMT3A. Therefore, this objective was not completed. | ||
| OTHER_PRE_SPECIFIED | Cytogenetic Risk Distribution of Patients on This Study | Baseline | Eligible patients with known cytogenetic risk at baseline | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Overall Survival (OS) | OS assessed for up to 5 years, 2 year OS reported | Eligible patients | Proportion of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Complete Response (CR) Rate | Up to 5 years | Eligible patients | Percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group620
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival (EFS) | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 0.36 | 95% Confidence Interval 0.30 to 0.42 | Proportion of participants | |
| Event-free Survival (EFS) | Arm II (High-dose Cytarabine, Idarubicin) | 0.41 | 95% Confidence Interval 0.35 to 0.46 | Proportion of participants | |
| Event-free Survival (EFS) | Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | 0.37 | 95% Confidence Interval 0.30 to 0.43 | Proportion of participants | |
| Rate of Allogeneic HCT | High Risk Patients in First Complete Remission | 65 | 95% Confidence Interval 56 to 74 | percentage of patients | |
| Disease-free Survival (DFS) Among High Risk Patients | High Risk Patients | 0.30 | 95% Confidence Interval 0.21 to 0.39 | Proportion of participants | |
| EFS of Arm I Compared to Arm II | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 0.36 | 95% Confidence Interval 0.30 to 0.42 | Proportion of participants | |
| EFS of Arm I Compared to Arm II | Arm II (High-dose Cytarabine, Idarubicin) | 0.41 | 95% Confidence Interval 0.35 to 0.46 | Proportion of participants | |
| Frequency and Severity of Toxicities | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | Abdominal distension | 1 | Participants | |
| Frequency and Severity of Toxicities | Arm II (High-dose Cytarabine, Idarubicin) | Abdominal distension | 0 | Participants | |
| Frequency and Severity of Toxicities | Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | Abdominal distension | 1 | Participants |
1 to 10 of 620Source ClinicalTrials.gov
See all 620 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 263 | |
| Overall Study | STARTED | Arm II (High-dose Cytarabine, Idarubicin) | 267 | |
| Overall Study | STARTED | Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | 224 | |
| Overall Study | High Risk Patients | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 60 | |
| Overall Study | High Risk Patients | Arm II (High-dose Cytarabine, Idarubicin) | 61 | |
| Overall Study | High Risk Patients | Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | 38 | |
| Overall Study | High Risk Patients Achieved CR/CRi | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 38 | |
| Overall Study | High Risk Patients Achieved CR/CRi | Arm II (High-dose Cytarabine, Idarubicin) | 40 | |
| Overall Study | High Risk Patients Achieved CR/CRi | Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | 29 | |
| Overall Study | Known NPM1 Status at Baseline | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 169 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events633
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 | Anemia | Blood and lymphatic system disorders | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 185 | 261 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (High-dose Cytarabine, Idarubicin) | 185 | 259 | |
| other | Anemia | Blood and lymphatic system disorders | Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | 137 | 211 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 158 | 261 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (High-dose Cytarabine, Idarubicin) | 170 | 259 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | 120 | 211 | |
| other | Sinus bradycardia | Cardiac disorders | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 11 | 261 | |
| other | Sinus bradycardia | Cardiac disorders | Arm II (High-dose Cytarabine, Idarubicin) | 9 | 259 | |
| other | Sinus bradycardia | Cardiac disorders | Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | 12 | 211 | |
| other | Sinus tachycardia | Cardiac disorders | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 44 | 261 |
1 to 10 of 633Source ClinicalTrials.gov
See all 633 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 126 | 261 |
| Total, all-cause mortality | Arm II (High-dose Cytarabine, Idarubicin) | 114 | 259 |
| Total, all-cause mortality | Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | 103 | 211 |
| Total, other adverse events | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 249 | 261 |
| Total, other adverse events | Arm II (High-dose Cytarabine, Idarubicin) | 254 | 259 |
| Total, other adverse events | Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | 206 | 211 |
| Total, serious adverse events | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 11 | 261 |
| Total, serious adverse events | Arm II (High-dose Cytarabine, Idarubicin) | 27 | 259 |
| Total, serious adverse events | Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | 75 | 211 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | 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.
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