Acute Myeloid Leukemia Clinical Trial

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

Summary

A study evaluating the effectiveness and safety of venetoclax, in combination with azacitidine or decitabine, in an outpatient setting for treatment-naïve participants with AML who are ineligible for intensive chemotherapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant has confirmation of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria.
Participant is deemed by the investigator to be an appropriate candidate for outpatient ramp-up of venetoclax.
Participant is not eligible to receive treatment with standard cytarabine and anthracycline induction regimens.
Participant has not received prior treatment for AML (treatment naïve) with the exception of hydroxyurea.
Participant has no evidence of spontaneous tumor lysis syndrome (TLS) at Screening.
Participant can have progressed from myelodysplastic syndrome (MDS) or be considered to have secondary AML and could have been treated with growth factors or other agents with the exception of hypomethylating agents.
Participant has adequate kidney, liver and hematology laboratory values as detailed in the protocol.
Has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 3.

Exclusion Criteria:

Has a history of the following conditions:

Acute promyelocytic leukemia
Known active central nervous system involvement with AML
Positive for HIV (HIV testing is not required)
Positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months
Cardiovascular disability status of New York Heart Association Class > 2
Chronic respiratory disease that requires continuous oxygen or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study
Malabsorption syndrome or other condition that precludes enteral route of administration

Has a history of other malignancies within 2 years prior to study entry, with the exception of:

Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast
Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

54

Study ID:

NCT03941964

Recruitment Status:

Completed

Sponsor:

AbbVie

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There are 16 Locations for this study

See Locations Near You

Arizona Oncology Associates, PC-HOPE /ID# 211509
Tempe Arizona, 85284, United States
Colorado Blood Cancer Institute /ID# 212800
Denver Colorado, 80218, United States
Rocky Mountain Cancer Centers /ID# 211508
Lone Tree Colorado, 80124, United States
Fort Wayne Medical Oncology /ID# 223523
Fort Wayne Indiana, 46804, United States
Minnesota Oncology Hematology, PA /ID# 212837
Minneapolis Minnesota, 55404, United States
Oncology Hematology Care, Inc. /ID# 212779
Cincinnati Ohio, 45236, United States
Willamette Valley Cancer Institute and Research Center /ID# 211504
Eugene Oregon, 97401, United States
Charleston Oncology, P.A. /ID# 211471
Charleston South Carolina, 29414, United States
Prisma Health Cancer Inst - Eastside /ID# 211466
Greenville South Carolina, 29615, United States
Tennessee Oncology - Chattanooga / McCallie /ID# 212717
Chattanooga Tennessee, 37404, United States
Tennessee Oncology-Nashville Centennial /ID# 210944
Nashville Tennessee, 37203, United States
Texas Oncology - Austin Midtown /ID# 212780
Austin Texas, 78705, United States
Texas Oncology - Medical City Dallas /ID# 211503
Dallas Texas, 75230, United States
Texas Transplant Institute /ID# 213311
San Antonio Texas, 78229, United States
Texas Oncology - San Antonio Medical Center /ID# 211510
San Antonio Texas, 78240, United States
Texas Oncology - Northeast Texas /ID# 213908
Tyler Texas, 75702, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

54

Study ID:

NCT03941964

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

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