NCT01831232 · REGISTRY CONDITION SEARCH

Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2017-11-17

This clinical trial studies idarubicin, cytarabine, and pravastatin sodium in treating patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving idarubicin and cytarabine together with pravastatin sodium may kill more cancer cells.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Good Complete Remission (CR)

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outcome · POSTED

Number of Participants With TRM.

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Survival

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outcome · POSTED

Number of Biomarker-positive Participants With Clinical Responses

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outcome · POSTED

Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of acute myeloid leukemia by World Health Organization (WHO) 2008 criteria, including patients with \>= 20% blasts in the bone marrow or peripheral blood (except acute promyelocytic leukemia), or myelodysplastic syndrome refractory anemia with excess blasts (RAEB)-2 by WHO classification or advanced myeloproliferative neoplasm with \>= 10% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) CMML-2 by WHO 2008 classification * Untreated AML or high-risk myelodysplastic syndrome (MDS) and a simplified TRM score of =\< 9.2 * Bilirubin \< 2.0 mg/ml * Any creatinine value is acceptable * Any performance status is eligible * Life expectancy otherwise \> 1 year * Patients are not excluded based on cardiac history * Females of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment * Patients must use an effective contraceptive method during the study and for a minimum of 90 days after study treatment * Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
healthy Volunteers: false
maximum Age: 74 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm 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.
intervention Names
Drug: pravastatin sodium
Drug: idarubicin
Drug: cytarabine
Other: laboratory biomarker analysis
label
Treatment (pravastatin sodium, idarubicin, and cytarabine)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (pravastatin sodium, idarubicin, and cytarabine)
description
Given PO
name
pravastatin sodium
other Names
PRAV
Pravachol
type
DRUG
arm Group Labels
Treatment (pravastatin sodium, idarubicin, and cytarabine)
description
Given IV
name
idarubicin
other Names
4-demethoxydaunorubicin
4-DMDR
DMDR
IDA
type
DRUG
arm Group Labels
Treatment (pravastatin sodium, idarubicin, and cytarabine)
description
Given IV
name
cytarabine
other Names
ARA-C
arabinofuranosylcytosine
arabinosylcytosine
Cytosar-U
cytosine arabinoside
type
DRUG
arm Group Labels
Treatment (pravastatin sodium, idarubicin, and cytarabine)
description
Correlative studies
name
laboratory biomarker analysis
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 24
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants With Good Complete Remission (CR)
time Frame
35 days
description
A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used. TRM: Treatment Related Mortality
measure
Number of Participants With TRM.
time Frame
28 days

secondary Outcomes

measure
Progression Free Survival (PFS)
time Frame
1 year after treatment with IAP
description
Amount of time a patient lives after treatment with IAP
measure
Overall Survival
time Frame
1 year after treatment with IAP
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).
measure
Number of Biomarker-positive Participants With Clinical Responses
time Frame
38 days after dosing
description
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)
measure
Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR)
time Frame
35 days

Full study description

brief Summary: This clinical trial studies idarubicin, cytarabine, and pravastatin sodium in treating patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving idarubicin and cytarabine together with pravastatin sodium may kill more cancer cells.
detailed Description: PRIMARY OBJECTIVES: I. To assess the rate of achieving a "good complete response (CR)" after treating patients with newly diagnosed acute myeloid leukemia (AML) with idarubicin, cytarabine and pravastatin (pravastatin sodium) (IAP). II. To determine the toxicity (death within 28 days of starting therapy = treatment related mortality or "TRM") with IAP in newly-diagnosed AML. SECONDARY OBJECTIVES: I. To determine rates of complete remission (CR), remission with incomplete blood count recovery (CRi), partial remission (PR), relapse-free survival and overall survival. II. To identify biomarkers (ie. changes in serum cholesterol) associated with clinical responses. OUTLINE: Patients receive pravastatin sodium orally (PO) once daily (QD) on days 1-8, idarubicin intravenously (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. After completion of study treatment, patients are followed up every 3 months for 2 years and then annually for 3 years.

Source references

Source notices and limitations

Discovery and provenance

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exact text
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query cond
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source file
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source url
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Preserved source evidence · Not medical advice