Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia

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Brief Title

Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia

Official Title

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

Brief Summary

      This phase I/II trial studies the side effects and best dose of dasatinib when given together
      with cytarabine and idarubicin hydrochloride and to see how well they work in treating
      patients with acute myeloid leukemia that is likely to come back or spread. Dasatinib may
      stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs
      used in chemotherapy, such as cytarabine and idarubicin hydrochloride, work in different ways
      to stop the growth of cancer cells, either by killing the cells or by stopping them from
      dividing. Giving dasatinib together with cytarabine and idarubicin hydrochloride may be a
      better treatment for acute myeloid leukemia.
    

Detailed Description

      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 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 Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Maximum Tolerated Dose of Dasatinib (Phase I)

Secondary Outcome

 Overall Survival (Phase II)

Condition

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Intervention

cytarabine

Study Arms / Comparison Groups

 Dasatinib 100mg/day + Cytarabine 200mg/m2/day + Idarubicin 12mg/m2/day
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

September 13, 2013

Completion Date

April 25, 2018

Primary Completion Date

April 25, 2018

Eligibility Criteria

        Inclusion Criteria:

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

               -  Newly diagnosed, age 60 and older

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

               -  Relapsed or refractory to prior chemotherapy

               -  Secondary AML

          -  Any prior chemotherapy must have been completed >= 2 weeks prior to day 1 of study
             treatment and the participant must have recovered to eligibility levels from prior
             toxicity

               -  Only one prior regimen is allowed for relapsed 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 day 1 of study treatment 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 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

          -  Patients with Chronic Myelogenous Leukemia (CML) in Myeloid blasts crisis

          -  Active infections, including opportunistic infections

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ahmed Aribi, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01876953

Organization ID

12393

Secondary IDs

NCI-2013-01141

Responsible Party

Sponsor

Study Sponsor

City of Hope Medical Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Ahmed Aribi, Principal Investigator, City of Hope Medical Center


Verification Date

March 2022