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Clinical Trial VICCHEM1336

Title

A Randomized, Blinded, Placebo-Controlled, Dose Finding Study to Assess the Safety and Efficacy of the Oral Thrombopoietin Receptor Agonist, Eltrombopag, Administered to Subjects with Acute Myelogenous Leukaemia (AML) Receiving Induction Chemotherapy

Principal Investigator(s)

Stephen Strickland

Details

  • Protocol No. VICCHEM1336
  • Open Date: 12/09/2013
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: To assess the safety and tolerability of eltrombopag versus placebo in subjects receiving standard induction therapy for acute myeloid leukemia (AML)
  • Disease Sites: Leukemia
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Cytarabine (ARA-C); Daunorubicin (Daunomycin); Eltrombopag
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01890746
  • Secondary Protocol No: TRC117146

Description

The purpose of this study is to test a drug called eltrombopag in patients diagnosed with a disease called acute myelogenous leukemia (AML) who are scheduled to receive a standard treatment using a combination of 2 chemotherapy drugs. In this study, patients with AML will be treated with chemotherapy using 2 drugs called daunorubicin plus cytarabine. The study is being done to make sure that eltrombopag is safe and if it works as we think it should. Eltrombopag is an investigational treatment for a condition called thrombocytopenia. Thrombocytopenia means you have low levels of platelets in your blood. Platelets are very small cells that help you to control bleeding. Thrombocytopenia sometimes happens in patients with AML and in everyone treated with daunorubicin plus cytarabine. Eltrombopag is not yet approved for doctors to treat thrombocytopenia in patients with AML. We want to find out if it is safe for AML patients to receive eltrombopag and what effects, good or bad, it has on people with AML who are treated with daunorubicin plus cytarabine.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria
• Age >=18 years
• Diagnosed with AML according to the WHO 2008 classification. Note: subjects with secondary AML following Myelodysplastic syndrome or secondary to previous leukemogenic therapy are allowed provided that a record of previous MDS history or leukemogenic therapy history is available.
• Eligible for induction by daunorubicin + cytarabine.
• Eligible to give informed consent to participate in the study.
• Have adequate baseline organ function defined by the following criteria:
Total bilirubin <=1.5 x upper limit of normal (ULN) except for Gilbert's syndrome, or other conditions that are not indicative of inadequate liver function (i.e. elevation of indirect bilirubin (haemolytic) in the absence of alanine aminotransferase [ALT] abnormality).
ALT <=3 x ULN. Serum Creatinine <=2.5 x ULN.
• Adequate cardiac function with LVEF >=50% as assessed by echocardiogram (ECHO) or Multi Gated Acquisition Scan (MUGA.
• Subjects with a QT interval corrected for heart rate according to Bazett's formula (QTcB) <450millisecond (msec) or <480msec for subjects with bundle branch block. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period.
• Women must be either of non-childbearing potential or women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study.
• Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of randomization until 30 days after the last dose of investigational product.
• Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception during the study and for 30 days following the last dose of investigational product.
Exclusion Criteria
• A diagnosis of acute promyelocytic (M3) or acute megakaryocytic leukaemia (M7).
• Previous history of exposure to an anthracycline compound.
• Previous AML treatment (other than hydroxyurea).
• Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent.
• History of thromboembolic event or other condition requiring ongoing use of anticoagulation either with warfarin or low molecular-weight heparin. Note: Occlusion of a central line is not exclusion.
• Treatment with an investigational drug within 30 days or 5 half lives, whichever is longer, preceding the first dose of study medication.
• Current and continued use during study treatment period of known Breast cancer resistance protein (BCRP) inhibitors or known P-gp inhibitors.
• Known active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection.
• Known hypersensitivity to any of the study drugs or its excipients.