A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 15, 2019

Primary Completion Date

March 14, 2022

Study Completion Date

March 14, 2022

Conditions
Acute Myeloid Leukemia (AML)Cancer
Interventions
DRUG

Venetoclax

Venetoclax tablets were to be taken orally once daily with a meal and water in the morning at approximately the same time each day. Tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing. On the days that the participant received either azacitidine or decitabine, venetoclax was dosed in clinic and administered prior to these agents.

DRUG

Azacitidine

The azacitidine infusion was prepared and administered per the package insert and given either subcutaneously or intravenously, per institutional practice.

DRUG

Decitabine

The decitabine infusion was prepared and administered per the package insert and given intravenously, per institutional practice.

Trial Locations (16)

29615

Prisma Health Cancer Inst - Eastside /ID# 211466, Greenville

46804

Fort Wayne Medical Oncology /ID# 223523, Fort Wayne

55404

Minnesota Oncology Hematology, PA /ID# 212837, Minneapolis

75230

Texas Oncology - Medical City Dallas /ID# 211503, Dallas

75702

Texas Oncology - Northeast Texas /ID# 213908, Tyler

78229

Texas Transplant Institute /ID# 213311, San Antonio

78705

Texas Oncology - Austin Midtown /ID# 212780, Austin

80124

Rocky Mountain Cancer Centers /ID# 211508, Lone Tree

80218

Colorado Blood Cancer Institute /ID# 212800, Denver

85284-1812

Arizona Oncology Associates, PC-HOPE /ID# 211509, Tempe

45236-2725

Oncology Hematology Care, Inc. /ID# 212779, Cincinnati

97401-6043

Willamette Valley Cancer Institute and Research Center /ID# 211504, Eugene

29414-7710

Charleston Oncology, P.A. /ID# 211471, Charleston

37404-3230

Tennessee Oncology - Chattanooga / McCallie /ID# 212717, Chattanooga

37203-1632

Tennessee Oncology-Nashville Centennial /ID# 210944, Nashville

78240-5251

Texas Oncology - San Antonio Medical Center /ID# 211510, San Antonio

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY