A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

Stopped early · Phase 3

Conditions studied: Acute Myeloid Leukemia (AML), Cancer

In brief

The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).

Key facts

Study ID

NCT04161885

Run by

AbbVie

People needed

465

Starts

2020-02-26

Expected to finish

2025-09-23

Last updated by the study team

2026-06-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2.
• Participant must be diagnosed with Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 60 days.
• Blast percentage in bone marrow before transplant must be < 10%.
• Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must be < 5% after transplant.
• Participant meet adequate renal, hepatic and hematologic criteria as described in the protocol.
• Participants >= 17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and participants between 12 to 16 years old must have a Lansky Play Performance Scale score > 40.

You may not qualify if…

• History of disease progression during prior treatment with venetoclax.
• History of any other malignancy within 2 years prior to study entry, except for: 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; Myelodysplastic Syndrome, Myeloproliferative neoplasm (only allowed if it transformed to AML and AML should be the indication for marrow transplantation).
• Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.

Where it is running

• University of Arizona Cancer Center - Tucson /ID# 242507 — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences /ID# 239804 — Little Rock, Arkansas, United States
• City of Hope /ID# 213681 — Duarte, California, United States
• UCHSC Anschultz Cancer Pavilion /ID# 215618 — Aurora, Colorado, United States
• Colorado Blood Cancer Institute /ID# 215980 — Denver, Colorado, United States
• Mayo Clinic Hospital Jacksonville /ID# 239710 — Jacksonville, Florida, United States
• AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985 — Orlando, Florida, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 215840 — Chicago, Illinois, United States
• The University of Chicago Medical Center /ID# 215616 — Chicago, Illinois, United States
• Loyola University Medical Ctr /ID# 215617 — Maywood, Illinois, United States
• Indiana Blood & Marrow Transpl /ID# 215842 — Indianapolis, Indiana, United States
• Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 213834 — New Orleans, Louisiana, United States
• University of Maryland, Baltimore /ID# 213855 — Baltimore, Maryland, United States
• Massachusetts General Hospital /ID# 215765 — Boston, Massachusetts, United States
• Karmanos Cancer Institute - Dresner Clinic /ID# 214581 — Detroit, Michigan, United States
• Masonic Cancer Center /ID# 239492 — Minneapolis, Minnesota, United States
• Mayo Clinic - Rochester /ID# 214685 — Rochester, Minnesota, United States
• University of Mississippi Medical Center /ID# 239343 — Jackson, Mississippi, United States
• The John Theurer Cancer /ID# 215251 — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute /ID# 217857 — Buffalo, New York, United States
• Columbia University Medical Center /ID# 240875 — New York, New York, United States
• Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680 — New York, New York, United States
• Weill Cornell Medical College /ID# 214887 — New York, New York, United States
• Montefiore Medical Center - Moses Campus /ID# 241669 — The Bronx, New York, United States
• Arizona Oncology - Scottsdale - Cancer Transplant Institute /ID# 239711 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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