Acute Myeloid Leukemia Clinical Trial

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)

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 allogeneic hematopoietic cell transplantation, and to assess if the combination treatment is well tolerated and prevents disease relapse after transplant.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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)
Exclusion Criteria:

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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

25

Study ID:

NCT06158100

Recruitment Status:

Not yet recruiting

Sponsor:

Antonio M Jimenez Jimenez

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There is 1 Location for this study

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University of Miami
Miami Florida, 33136, United States More Info
Antonio M Jimenez Jimenez, MD
Contact
305-243-3379
[email protected]
Antonio M Jimenez Jimenez, MD
Principal Investigator
Trent Wang, MD
Principal Investigator
Justin Watts, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

25

Study ID:

NCT06158100

Recruitment Status:

Not yet recruiting

Sponsor:


Antonio M Jimenez Jimenez

How clear is this clinincal trial information?

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