Trial · NCT00840177
S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia
NCT00840177, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2020-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia. Trials, record NCT00840177. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00840177
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia
- NCT number
- NCT00840177
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 115 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Leukemia
- Interventions
- cytarabine, idarubicin, pravastatin sodium
- First posted
- 2009-02-10
- Last updated
- 2023-05-03
- Results first posted
- 2020-01-13
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 (Including CR With Incomplete Recovery) | Up to 5 years after registration | Participants who achieved morphological complete remission with or without incomplete blood count recovery. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL. |
| Secondary | Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0 | Up to 5 years post registration | 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 | Correlation Between Pre-study Cytogenetic Features and Response | 5 years | |
| Other | Overall Survival (OS) | OS assessed for up to 5 years, median OS reported | OS is calculated for all participants from the date of initial registration on study until death from any cause. Observations for participants last known to be alive were censored. |
| Other | Relapse-free Survival (RFS) | RFS assessed for up to 5 years, median RFS reported | RFS is calculated for participants who have achieved a complete response (CR) or CR with incomplete blood count recovery (CRi). RFS 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. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL. |
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 (Including CR With Incomplete Recovery) | Up to 5 years after registration | Eligible participants who started treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0 | Up to 5 years post registration | Eligible patients who were assessed for adverse events | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Correlation Between Pre-study Cytogenetic Features and Response | 5 years | |||
| OTHER_PRE_SPECIFIED | Overall Survival (OS) | OS assessed for up to 5 years, median OS reported | Eligible participants who started treatment | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Relapse-free Survival (RFS) | RFS assessed for up to 5 years, median RFS reported | Eligible participants who started treatment | months | MEDIAN |
Source ClinicalTrials.gov
Results by group294
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 (Including CR With Incomplete Recovery) | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month | 27 | Participants | ||
| Complete Remission (CR) Rate (Including CR With Incomplete Recovery) | Poor-risk Cohort: MDS Transformed to AML | 14 | Participants | ||
| Complete Remission (CR) Rate (Including CR With Incomplete Recovery) | Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission | 14 | Participants | ||
| Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0 | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 | Participants | |
| Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0 | Poor-risk Cohort: MDS Transformed to AML | ALT, SGPT (serum glutamic pyruvic transaminase) | 2 | Participants | |
| Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0 | Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission | ALT, SGPT (serum glutamic pyruvic transaminase) | 2 | Participants | |
| Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0 | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month | AST, SGOT | 0 | Participants | |
| Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0 | Poor-risk Cohort: MDS Transformed to AML | AST, SGOT | 3 | Participants | |
| Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0 | Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission | AST, SGOT | 1 | Participants | |
| Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0 | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month | Acidosis (metabolic or respiratory) | 0 | Participants |
1 to 10 of 294Source ClinicalTrials.gov
See all 294 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month | 36 | |
| Overall Study | STARTED | Poor-risk Cohort: MDS Transformed to AML | 29 | |
| Overall Study | STARTED | Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission | 50 | |
| Overall Study | Treated | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month | 36 | |
| Overall Study | Treated | Poor-risk Cohort: MDS Transformed to AML | 29 | |
| Overall Study | Treated | Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission | 46 | |
| Overall Study | Assessed for AEs | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month | 35 | |
| Overall Study | Assessed for AEs | Poor-risk Cohort: MDS Transformed to AML | 29 | |
| Overall Study | Assessed for AEs | Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission | 46 | |
| Overall Study | COMPLETED | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month | 18 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events447
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 | Blood/Bone Marrow-Other | Blood and lymphatic system disorders | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Mnths | 2 | 35 | |
| other | Blood/Bone Marrow-Other | Blood and lymphatic system disorders | Poor-risk Cohort: MDS Transformed to AML | 2 | 29 | |
| other | Blood/Bone Marrow-Other | Blood and lymphatic system disorders | Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission | 0 | 46 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Mnths | 21 | 35 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Poor-risk Cohort: MDS Transformed to AML | 22 | 29 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission | 33 | 46 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Mnths | 13 | 35 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Poor-risk Cohort: MDS Transformed to AML | 21 | 29 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission | 23 | 46 | |
| other | Lymphatics-Other | Blood and lymphatic system disorders | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Mnths | 0 | 35 |
1 to 10 of 447Source ClinicalTrials.gov
See all 447 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Mnths | 27 | 36 |
| Total, all-cause mortality | Poor-risk Cohort: MDS Transformed to AML | 20 | 29 |
| Total, all-cause mortality | Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission | 41 | 46 |
| Total, other adverse events | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Mnths | 34 | 35 |
| Total, other adverse events | Poor-risk Cohort: MDS Transformed to AML | 28 | 29 |
| Total, other adverse events | Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission | 45 | 46 |
| Total, serious adverse events | Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Mnths | 5 | 35 |
| Total, serious adverse events | Poor-risk Cohort: MDS Transformed to AML | 8 | 29 |
| Total, serious adverse events | Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission | 10 | 46 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29618479 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
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/NCT00840177
GET https://conductscience.org/api/trials/v1/NCT00840177/results?page=2