Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT01876953|
Recruitment Status : Active, not recruiting
First Posted : June 13, 2013
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|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(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Recurrent Adult Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia||Drug: cytarabine Drug: idarubicin Drug: dasatinib Other: laboratory biomarker analysis||Phase 1 Phase 2|
I. Of the dose levels studied, to determine the maximum tolerated dose of dasatinib when given in combination with cytarabine and idarubicin for treatment of high risk acute myeloid leukemia (AML). (Phase I)
II. To determine the anti-tumor activity of dasatinib when given in combination with cytarabine and idarubicin, as assessed by complete remission rate (CR) and remission duration. (Phase II)
I. To document CR and survival outcomes (overall, event-free). (Phase I)
II. To estimate the survival probabilities (overall and event-free) and cumulative incidence of relapse/progression. (Phase II)
III. To describe and summarize all toxicities by organ and severity. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of dasatinib, followed by a phase II study.
Patients receive cytarabine intravenously (IV) continuously over 168 hours on days 1-7, dasatinib orally (PO) once daily (QD) on days 1-7, and idarubicin hydrochloride IV on days 1-3. Patients with non-responsive disease on day 30 may receive a second course of therapy (re-induction therapy) within 1 week in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 2 months for up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of the Combination of Dasatinib With Chemotherapy for High Risk Acute Myeloid Leukemia (AML) Patients|
|Actual Study Start Date :||September 10, 2013|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
Experimental: Treatment (cytarabine, idarubicin, and dasatinib)
Patients receive cytarabine IV continuously over 168 hours on days 1-7, dasatinib PO QD on days 1-7, and idarubicin hydrochloride IV on days 1-3. Patients with non-responsive disease on day 30 may receive a second course of therapy (re-induction therapy) within 1 week in the absence of unacceptable toxicity.
Other Names:Drug: idarubicin
Other Names:Drug: dasatinib
Other Names:Other: laboratory biomarker analysis
- Maximum tolerated dose of dasatinib, determined according to incidence of dose limiting toxicity (DLT), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: Up to 42 days ]
- CR rate (Phase II) [ Time Frame: Up to 2 years ]Remission rates will be calculated as the percent of evaluable patients that have a confirmed CR, and exact 95% confidence intervals will be calculated for these estimates.
- Remission duration (Phase II) [ Time Frame: Up to 2 years ]Will be estimated using the product-limit method of Kaplan and Meier.
- Overall survival (Phase II) [ Time Frame: Time from start of study therapy until death, or last contact, whichever comes first, assessed up to 2 years ]Will be estimated using the product-limit method of Kaplan and Meier.
- Event-free survival (Phase II) [ Time Frame: Time from start of study therapy until death, relapse/progression, receipt of anti-leukemia therapy, or last contact, whichever comes first, assessed up to 2 years ]Will be estimated using the product-limit method of Kaplan and Meier.
- Cumulative incidence of relapse/progression (Phase II) [ Time Frame: Up to 2 years ]
- Incidence of toxicities, graded according to NCI CTCAE version 4.0(Phase II) [ Time Frame: Up to 30 days ]Observed toxicities will be summarized in terms of type (organ affected or laboratory determination) severity (by NCI CTCAE v4.0), date of onset, duration, reversibility, and attribution. Tables will be created to summarize these toxicities and side effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876953
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Ahmed Aribi||City of Hope Medical Center|