Ibrutinib, Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Not Recruiting

Trial ID: NCT02635074


This phase I trial studies the side effects and best dose of ibrutinib when given together with idarubicin and cytarabine in treating patients with acute myeloid leukemia that has returned after a period of improvement or has not responded to previous treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib together with idarubicin and cytarabine may kill more cancer cells.

Official Title

A Phase I Dose Escalation Study of Ibrutinib With Idarubicin/Cytarabine for Relapsed/Refractory Acute Myeloid Leukemia

Stanford Investigator(s)

Rondeep Brar
Rondeep Brar

Clinical Associate Professor, Medicine - Hematology



   - Previous morphologically-confirmed diagnosis of acute myeloid leukemia (AML) based on
   World Health Organization (WHO) Criteria

   - At least one prior chemotherapy regimen to treat AML

   - Disease relapse or refractory disease as shown by > 5% blasts in the bone marrow (not
   attributable to another cause). Administration of hydrea to control high WBC count is

   - Age ≥ 18 years

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, or Karnofsky
   Performance Status (KPS) ≥ 60%

   - Life expectancy > 4 weeks

   - Platelet count ≥ 10,000/mm3 within 72 hours of initiating the Induction Cycle
   (platelet transfusion support is allowed)

   - Serum creatinine ≤ 2.0 mg/dL within 72 hours of initiating the Induction Cycle

   - Total bilirubin ≤ 2.1 mg/dL within within 72 hours of initiating the Induction Cycle
   (EXCEPTION: If elevation is not due to liver dysfunction, and is due primarily to
   elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome, or hemolysis
   of non-hepatic origin)

   - Serum glutamic oxaloacetic transaminase (SGOT) [aspartate aminotransferase (AST) ] ≤
   3.0 X upper limit of normal (ULN) within 72 hours of initiating the Induction Cycle

   - Serum glutamic pyruvic transaminase (SGPT) [alanine aminotransferase (ALT)] ≤ 3.0 X
   ULN within 72 hours of initiating the Induction Cycle

   - Baseline prothrombin time (PT)/international normalized ratio (INR) ratio < 3 X ULN
   within 7 days of initiating the Induction Cycle (for subjects with correctable
   coagulation abnormalities, coagulation factor support per institutional standard of
   care for AML is allowed)

   - Partial thromboplastin time (PTT) < 3 X ULN within 7 days of initiating the Induction
   Cycle (for subjects with correctable coagulation abnormalities, coagulation factor
   support per institutional standard of care for AML is allowed)

   - Negative pregnancy test within 14 days prior to study treatment (for Women of
   reproductive potential only)

   - Women of child-bearing potential and men must agree (in ICF) to use adequate
   contraception (eg, hormonal or barrier methods of birth control; abstinence;
   sterilized partner) for the duration of study participation

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


   - Received anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or
   investigational therapy) within 2 weeks prior to starting study treatment [EXCEPTION:
   Hydroxyurea (hydrea) to control high white blood cell count is permitted]

   - Receiving any other investigational agents within 14 days or 5 effective half lives
   (whichever is shorter) prior to 1st dose of ibrutinib

   - Prior treatment with ibrutinib

   - Known unresolved toxicities due to prior anticancer therapy [≥ Grade 2, by Common
   Terminology Criteria for Adverse Events (CTCAE) v4.03] unless otherwise defined in the
   inclusion/exclusion criteria (EXCEPTION: alopecia)

   - Known acute promyelocytic leukemia (French-American-British Class M3-AML)

   - Known active central nervous system (CNS) leukemia

   - Prior bone marrow transplant presenting with active uncontrolled graft vs host disease

   - Known congenital bleeding disorders, such as hemophilia

   - Known history of stroke or intracranial hemorrhage within 6 months prior to study

   - Concomitant use of warfarin or other vitamin K antagonists

   - Requires treatment with strong CYP3A inhibitors at the time of study enrollment.
   Washout period is 5 effective half-lives is required prior to 1st dose of ibrutinib

   - Requires treatment with strong CYP3A inducers at the time of study enrollment. Washout
   period is 5 effective half-lives is required prior to 1st dose of ibrutinib

   - Known active uncontrolled systemic infection

   - Major surgery within 4 weeks of 1st dose of ibrutinib

   - Unable to swallow capsules

   - Known Malabsorption syndrome

   - Known Disease significantly affecting gastrointestinal function

   - Resection of the stomach or small bowel

   - Uncontrolled symptomatic inflammatory bowel disease

   - Ulcerative colitis

   - Bowel obstruction, partial or complete

   - Congestive heart failure with ejection fraction (EF) < 45%

   - Uncontrolled cardiac disease, including uncontrolled cardiac arrhythmia or coronary
   artery disease (CAD) with active symptoms due to CAD defined as unstable angina

   - History of allergic reactions attributed to compounds of similar chemical or biologic
   composition to ibrutinib; idarubicin; or cytarabine

   - Uncontrolled intercurrent illness including, but not limited to:

   - Active infection

   - Psychiatric illness/social situations that would limit compliance with study

   - Pregnant

   - Lactating

   - Known positive HIV

   - Known active hepatitis C

   - Unable to understand the purpose and risks of the study and to provide a signed and
   dated informed consent form (ICF) and authorization to use protected health
   information (in accordance with national and local subject privacy regulations)


drug: Cytarabine

drug: Ibrutinib

drug: Idarubicin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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