Study of Ibrutinib in Subjects With Acute Myeloid Leukemia

PHASE2TerminatedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

April 30, 2017

Study Completion Date

April 30, 2017

Conditions
Acute Myeloid Leukemia (AML)
Interventions
DRUG

Ibrutinib

Subjects will receive ibrutinib 560 mg once daily on a continuing basis.

DRUG

Ibrutinib + LD-AraC

Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.

DRUG

Ibrutinib+Azacitidine

Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles).

Trial Locations (9)

10461

Montefiore Einstein Center for Cancer Research, The Bronx

14263

Roswell Park Cancer Institute, Buffalo

21231

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

52242

University of Iowa, Iowa City

60637

The University of Chicago Medical Center, Chicago

77030

MD Anderson Cancer Center, Houston

91010

City of Hope, Duarte

95817

UC Davis Medical Center, Sacramento

98109

Fred Hutchinson Cancer Research Center, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmacyclics LLC.

INDUSTRY