Trial · NCT01831232
Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
NCT01831232, Not applicable, Completed, Fred Hutchinson Cancer Center; results first posted 2017-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes. Trials, record NCT01831232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01831232
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
- NCT number
- NCT01831232
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 24 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Refractory Anemia With Excess Blasts, Untreated Adult Acute Myeloid Leukemia
- Interventions
- pravastatin sodium, idarubicin, cytarabine, laboratory biomarker analysis
- First posted
- 2013-04-15
- Last updated
- 2017-11-17
- Results first posted
- 2017-11-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Good Complete Remission (CR) | 35 days | A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used. Definition of Good CR: Conventional criteria for CR (absolute neutrophil count \> 1,000/uL, platelet count \> 100,000/uL, marrow with \<5% morphologic blasts) and additionally the requirements that marrow Minimal Residual Disease (MRD) - detected by 10-color flow cytometry or conventional cytogenetic evaluation - be absent and that the above blood counts be obtained. |
| Primary | Number of Participants With TRM. | 28 days | A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used. TRM: Treatment Related Mortality |
| Secondary | Progression Free Survival (PFS) | 1 year after treatment with IAP | |
| Secondary | Overall Survival | 1 year after treatment with IAP | Amount of time a patient lives after treatment with IAP |
| Secondary | Number of Biomarker-positive Participants With Clinical Responses | 38 days after dosing | Biomarkers: FLT3-ITD positive, NPM1 positive, CEBPA. A "good CR" is defined as \<5% blasts in the marrow by morphologic evaluation along with the absence of any MRD by flow cytometry or cytogenetics and recovery of blood counts (platelets \>100,00 and absolute neutrophil count \>1,000) by day 35 after induction. Cheson AML Response Criteria is used for Morphologic Leukemia Free State, Morphologic Complete Remission, Cytogenetic Complete Remission (CRc), Molecular Complete Remission (CRm), Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Partial Remission (PR), Treatment Failure, Recurrence (Progressive Disease). |
| Secondary | Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR) | 35 days | Complete remission (CR) - includes patients with good CR and CR with minimal residual disease (MRD); remission with incomplete blood count recovery (CRi), partial remission (PR) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Good Complete Remission (CR) | 35 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With TRM. | 28 days | participants | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) | 1 year after treatment with IAP | Patients who had a good complete remission (CR), CR with evidence of minimal residual disease (MRD), or complete remission with incomplete blood count recovery (CRi) following treatment. Cheson AML Response Criteria are used to assess response.Good CR is defined as \<5% blasts in marrow, no MRD and recovery of blood counts by day 35 after induction. | percentage of patients with PFS | NUMBER |
| SECONDARY | Overall Survival | 1 year after treatment with IAP | percentage of patients surviving | NUMBER | |
| SECONDARY | Number of Biomarker-positive Participants With Clinical Responses | 38 days after dosing | Participants with biomarkers: FLT3-ITD positive, NPM1 positive or CEBPA | participants with clinical responses | NUMBER |
| SECONDARY | Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR) | 35 days | All patient who received IAP treatment were assessed for response. The number of participants with CR, CRi and PR are included in the table below. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Good Complete Remission (CR) | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 12 | Participants | ||
| Number of Participants With TRM. | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 2 | 95% Confidence Interval 1 to 27 | participants | |
| Progression Free Survival (PFS) | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 52.6 | 95% Confidence Interval 28.7 to 71.9 | percentage of patients with PFS | |
| Overall Survival | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 53.5 | 95% Confidence Interval 32 to 71 | percentage of patients surviving | |
| Number of Biomarker-positive Participants With Clinical Responses | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 0 | participants with clinical responses | ||
| Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR) | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | CR | 15 | Participants | |
| Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR) | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | CRi | 2 | Participants | |
| Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR) | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | PR | 0 | 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 | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 24 | |
| Overall Study | COMPLETED | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 24 | |
| Overall Study | NOT COMPLETED | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 0 |
Source ClinicalTrials.gov
Adverse events13
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 | Febrile neutropenia Grade 3 | Blood and lymphatic system disorders | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 17 | 24 | 17 |
| other | Febrile neutropenia Grade 4 | Blood and lymphatic system disorders | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 1 | 24 | 1 |
| other | Rash Grade 3 | Skin and subcutaneous tissue disorders | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 3 | 24 | 3 |
| other | Hand-foot syndrome Grade 3 | Skin and subcutaneous tissue disorders | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 2 | 24 | 2 |
| other | Septic shock (Grade 4) | Infections and infestations | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 1 | 24 | 1 |
| other | Diarrhea Grade 3 | Gastrointestinal disorders | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 6 | 24 | 6 |
| other | Nausea/Vomiting | Gastrointestinal disorders | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 4 | 24 | 4 |
| other | Mucositis | Gastrointestinal disorders | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 3 | 24 | 3 |
| other | Transaminitis Grade 3 | Investigations | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 2 | 24 | 2 |
| other | Colon pneumatosis Grade 3 | Gastrointestinal disorders | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 1 | 24 | 1 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 6 | 24 |
| Total, other adverse events | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 24 | 24 |
| Total, serious adverse events | Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 2 | 24 |
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 |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | 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/NCT01831232
GET https://conductscience.org/api/trials/v1/NCT01831232/registered