NCT02203773 - Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML) | Biotech Hunter

Enrollment

212

Participants

Timeline

Start Date

October 6, 2014

Primary Completion Date

June 16, 2022

Study Completion Date

June 16, 2022

Conditions

Acute Myelogenous LeukemiaMyelogenous LeukemiaTreatment Naive AML

Interventions

DRUG

Posaconazole

Posaconazole will be administered orally twice a day on Cycle 1 Day 21 and once daily from Cycle 1 Day 22 to Cycle 1 Day 28.

DRUG

ABT-199

ABT-199 is taken orally once daily starting on Day 2 of cycle 1 and begin on day 1 of every other cycle thereafter. This is a dose escalation study, therefore the dose of ABT-199 will change.

DRUG

Decitabine

Decitabine will be administered by IV infusion over 1 hour beginning on Day 1 thru Day 5 of each Cycle for a minimum of 4 Cycles

DRUG

Azacitidine

Azacitidine will be administered by IV infusion over 10 to 40 minutes or subcutaneously based on the institutional guidelines, beginning on Day 1 through Day 7 of each Cycle, for a minimum of 4 Cycles.

Trial Locations (23)

2217

St George Hospital /ID# 130356, Kogarah

3000

Peter MacCallum Cancer Ctr /ID# 130352, Melbourne

3004

Alfred Health /ID# 130353, Melbourne

21287

Johns Hopkins University /ID# 129699, Baltimore

30322

Emory Midtown Infectious Disease Clinic /ID# 129715, Atlanta

31059

Duplicate_Hopital Universitaire Purpan /ID# 134389, Toulouse

33604

Hopital Haut-Lévêque /ID# 134388, Pessac

75010

AP-HP - Hopital Saint-Louis /ID# 130349, Paris

77030

University of Texas MD Anderson Cancer Center /ID# 127860, Houston

University of Texas MD Anderson Cancer Center /ID# 141581, Houston

80045

Univ of Colorado Cancer Center /ID# 127859, Aurora

81675

Duplicate_Klinikum Rechts der Isar /ID# 130347, Munich

89081

Universitaetsklinikum Ulm /ID# 130341, Ulm

91010

City of Hope /ID# 129718, Duarte

95817

University of California, Davis Comprehensive Cancer Center /ID# 129719, Sacramento

98109

University of Washington /ID# 129717, Seattle

60611-2927

Northwestern University Feinberg School of Medicine /ID# 128741, Chicago

60637-1443

The University of Chicago Medical Center /ID# 128742, Chicago

02215

Dana-Farber Cancer Institute /ID# 127857, Boston

10032-3729

Columbia University Medical Center /ID# 130289, New York

27710-3000

Duke Cancer Center /ID# 129720, Durham

04103

Universitaetsklinikum Leipzig /ID# 130346, Leipzig

01307

Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 130342, Dresden