TriangleNCT01831232 · OUTCOME
Number of Biomarker-positive Participants With Clinical Responses
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants with clinical responses
- Interval / dispersion
- Not reported
- Time frame
- 38 days after dosing
What was measured
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).
Analysis population: Participants with biomarkers: FLT3-ITD positive, NPM1 positive or CEBPA
Groups in this outcome
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)
Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. pravastatin sodium: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies
| Group | Source count |
|---|---|
| Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- 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).
- groups
- description
- Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. pravastatin sodium: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies
- id
- OG000
- title
- Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)
- param Type
- NUMBER
- population Description
- Participants with biomarkers: FLT3-ITD positive, NPM1 positive or CEBPA
- reporting Status
- POSTED
- time Frame
- 38 days after dosing
- title
- Number of Biomarker-positive Participants With Clinical Responses
- type
- SECONDARY
- unit Of Measure
- participants with clinical responses
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice