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Volasertib Combined With Induction Chemotherapy in Acute Myeloid Leukemia

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Descriptive Information
Brief Title † Volasertib Combined With Induction Chemotherapy in Acute Myeloid Leukemia
Official Title † A Phase I Trial of Volasertib (BI 6727), an Intravenous Polo-Like Kinase Inhibitor, in Combination With "7+3" Induction Chemotherapy for Patients With Acute Myeloid Leukemia
Brief Summary The study intervention involved in this study is the addition of a dose of volasertib as a part of the initial chemotherapy regimen for AML. The trial will involve a combination of the following drugs: - Volasertib (the study drug) - Idarubicin - Cytarabine
Detailed Description This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. As part of this research study, the participant will receive Volasertib in combination with two other chemotherapy drugs, Idarubicin and Cytarabine. The FDA (the U.S. Food and Drug Administration) has not approved volasertib as a treatment for any disease. Idarubicin and Cytarabine are chemotherapy agents that are commonly used to treat individuals diagnosed with AML. Volasertib inhibits proteins called "polo-like kinases," which are necessary for cell division. Volasertib binds to these proteins and this inhibits the growth of cancer cells. Volasertib has been used in laboratory studies and those studies suggest that volasertib may slow down the growth of Cancer. In a previous clinical trial in patients with the participant type of leukemia where Volasertib was given along with low doses of Cytarabine, this drug was found to have some clinical activity against AML. In this study, researchers would like to combine Volasertib with standard chemotherapy (Cytarabine and Idarubicin) in order to see if it can be given safely with chemotherapy in individuals with AML. The primary purpose of this research study is to determine the highest dose that Volasertib can be given with Idarubicin and Cytarabine without severe or unmanageable side effects. The dose identified in this study will be used in future research studies.
Study Phase Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Establishing The Maximum Tolerated Dose (MTD)
Secondary Outcome Measure † Rate of Complete Response
Condition † AML
Intervention † DrugVolasertib
Study Arms / Comparison Groups Volasertib with chemotherapy Patients enrolled on this trial will receive induction chemotherapy with "7+3" Cytarabine continuous infusion days 1-7 Idarubicin IV bolus on days 1, 2, and 3. Patients will receive Volasertib as an intravenous infusion over approximately 1 hour, according to dosing level, on day 8 Patients will receive Standard Anti Fungal and Standard Antibiotic during induction A bone marrow biopsy will be performed according to standard practice on day 14
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 † 0
Start Date † September 2016
Completion Date September 2022
Primary Completion Date September 2019
Eligibility Criteria † Inclusion Criteria: - Participants must have pathologically confirmed, newly diagnosed acute myeloid leukemia. - Adults, age 18 years or older at the time of diagnosis, eligible for standard induction chemotherapy according to their treating physician. - ECOG performance status 0-2 (Karnofsky ≥60%, see Appendix A) - Left ventricular ejection fraction > 50% as measured by echocardiogram or MUGA scan - Must not have received systemic antineoplastic therapy including radiation therapy within 14 days of the study enrollment, except hydroxyurea or 6-mercaptopurine for the purposes of cytoreduction as per the treating physician. Patients may also have received all-trans retinoic acid (ATRA) if there is an early suspicion of acute promyelocytic leukemia (APL, M3-AML), although if confirmed to have APL these patients will be excluded from the study. - Female patients of childbearing age must have negative pregnancy test. - Participants must have normal organ and marrow function as defined below: - total bilirubin
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT02905994
Organization ID 16-299
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Massachusetts General Hospital
Collaborators †† Boehringer Ingelheim
Investigators † Principal Investigator: Amir T Fathi, MD, PhD, Massachusetts General Hospital
Information Provided By
Verification Date February 2017
First Received Date † September 12, 2016
Last Updated Date February 15, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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