Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

The main objective of this study is to evaluate the efficacy 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 efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).

Official Title

A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)

Keywords

Acute Myeloid Leukemia (AML) Cancer Venetoclax Azacitidine Stem Cell Transplantation (SCT) Best Support Care (BSC) Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Best Supportive Care (BSC)

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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 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 14 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 CAN'T join 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.
  • 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.

Locations

  • University of California, Los Angeles /ID# 218199 not yet accepting patients
    Los Angeles California 90095 United States
  • City of Hope /ID# 213681 accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT04161885
Phase
Phase 3
Study Type
Interventional
Last Updated