Status:
SUSPENDED
Venetoclax in Combination With Azacitidine (VEN/AZA) Followed by Donor Lymphocyte Infusion (DLI) for Patients With Very High-Risk Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
Lead Sponsor:
Antonio M Jimenez Jimenez
Collaborating Sponsors:
AbbVie
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see the effects of an investigational combination treatment of venetoclax, azacitidine, and donor lymphocyte infusion (DLI) in patients with high-risk AML receiving all...
Eligibility Criteria
Inclusion
- Male and female patients between the ages of 18-75.
- Patients with a histologic diagnosis of AML in morphological remission (\<5% bone marrow (BM) blasts) prior to allogeneic hematopoietic cell transplantation and very high-risk for relapse defined as: (i) Presence of measurable residual disease (MRD) by multicolor flow cytometry (MFC) prior to transplant and receiving a reduced intensity conditioning (RIC) or nonmyeloablative (NMA) regimen (ii) Presence of MRD by MFC at day +30 post-transplant (iii) All patients with monosomal karyotype (MK) and those with 17p/tumor protein p53 (TP53) mutated disease irrespective of MRD status and intensity of conditioning regimen.
- Adequate hematopoietic recovery after HCT, defined as:
- Absolute neutrophil count (ANC) \>= 1 x 10\^9/L without daily use of myeloid growth factors
- Platelet count \>= 50 x 10\^9/L without platelet transfusion within 1 week
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Serum creatinine =\< 1.5 mg/dL or creatinine clearance greater or equal than 40 cc/min
- Serum bilirubin =\< 1.5 x upper limit of normal (ULN)
- Aspartate transaminase (AST) or alanine transaminase (ALT) =\< 2.5 x ULN
- Alkaline phosphatase =\< 2.5 x UL
- Negative serum or urine pregnancy test for women with reproductive potential.
- A negative donor-specific antibody (DSA) assay (i.e., Micro-Flow Imaging (MFI) \<m3000) for recipients of any mismatched graft (including haploidentical) HCT.
Exclusion
- Active disease (\>5% blasts or any evidence of extra-medullary disease) at the time of transplantation or at day +30
- Active acute graft-versus-host disease (aGVHD) requiring systemic IST or history of aGVHD grade III or higher.
- Active chronic GVHD requiring systemic immunosuppressive therapy (IST).
- Active uncontrolled systemic fungal, bacterial, or viral infection
- Known active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- Significant active cardiac disease within the previous 6 months, including: New York Heart Association (NYHA) class III or IV congestive heart failure. Unstable angina, angina requiring surgical or medical intervention, and/or myocardial infarction.
- History of any other malignancy within 2 years prior to study entry, except for: adequately treated in situ carcinoma of the cervix 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.
Key Trial Info
Start Date :
December 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06158100
Start Date
December 4 2024
End Date
December 31 2027
Last Update
August 6 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136