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Phase I/II Study of the Combination of Dasatinib With Chemotherapy for High Risk Acute Myeloid Leukemia (AML) Patients


Phase 1/Phase 2
18 Years
70 Years
Not Enrolling
Both
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

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Trial Information

Phase I/II Study of the Combination of Dasatinib With Chemotherapy for High Risk Acute Myeloid Leukemia (AML) Patients


PRIMARY OBJECTIVES:

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)

SECONDARY OBJECTIVES:

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 IV on days 1-3. Patients
with non-responsive disease on day 30 may receive a second course of therapy 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.


Inclusion Criteria:



- Patients diagnosed with AML meeting one of the following criteria:

- Newly diagnosed, age 60 and older

- High risk cytogenetics (National Comprehensive Cancer Network [NCCN] criteria)

- Relapsed or refractory to prior chemotherapy

- Secondary AML

- Any prior therapy must have been completed >= 2 weeks prior to enrollment and the
participant must have recovered to eligibility levels from prior toxicity

- Only one prior regimen is allowed for AML patients; note one prior regimen is
defined as follows:

- Induction chemotherapy followed by consolidation is considered one regimen

- Induction chemotherapy followed by re-induction in case of persistent
disease followed by consolidation is considered one regimen

- Hydroxyurea is allowed prior to enrollment to keep white blood cell (WBC) below
20 K

- Karnofsky performance status >= 60%

- Total bilirubin < 1.5 x institutional upper limit of normal

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 x institutional upper limit of normal

- Creatinine < 1.5 x institutional upper limit or normal OR creatinine clearance >= 60
mL/min for patients with creatinine levels above 1.5 x institutional upper limit of
normal

- Ejection fraction (EF) >= 45%

- Ability to understand and the willingness to sign a written informed consent document

- Patients should not be receiving any other investigational agents

Exclusion Criteria:

- Patients with clinically significant illness which would compromise participation in
the study, including, but not limited to: active or uncontrolled infection, immune
deficiencies or confirmed diagnosis of human immunodeficiency virus (HIV) infection,
active hepatitis B, active hepatitis C, or uncontrolled diabetes, uncontrolled
hypertension, symptomatic congestive heart failure, unstable angina pectoris,
myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmias; or
psychiatric illness/social situations that would limit compliance with study
requirements

- Patients with additional (other than AML) currently active primary malignancy other
than curatively treated carcinoma in situ (CIS) of the cervix, or basal or squamous
cell carcinoma of the skin; patients are not considered to have a "currently active"
malignancy if they have completed therapy for a prior malignancy and disease free
from prior malignancies for > 2 years

- Patients with active central nervous system (CNS) disease

- Active infections, including opportunistic infections

- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
within 14 days of the first administration of oral dasatinib

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

Up to 42 days

Safety Issue:

Yes

Principal Investigator

Ahmed Aribi

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Federal Government

Study ID:

12393

NCT ID:

NCT01876953

Start Date:

August 2013

Completion Date:

Related Keywords:

  • 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
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

City of Hope Medical CenterDuarte, California  91010