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)

Overview

About this study

The main objective of this study is to evaluate the effectiveness of venetoclax in combination with azacitidine to improve Relapse Free Survival (RFS) in AML patients 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 effectiveness and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).

**Please note that at Mayo Clinic, this study will only be enrolling in Part 2 of the trial and will not be enrolling adolescents. We will be enrolling adult subjects only. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2.
  • Subject must be diagnosed with AML by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic SCT or have received allogeneic SCT within the past 60 days. All types and WHO categories of AML56 and any number of previous lines of therapy may be included.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/17/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mithun Shah, M.D., Ph.D.

Closed for enrollment

Contact information:

Chandra Hutchens M.A., M.B.A.

(507) 538-8955

Hutchens.Chandra@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Hemant Murthy, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available