Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06158100 | RECRUITING | Acute Myeloid Leukemia

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)
Sponsor:

Antonio M Jimenez Jimenez

Information provided by (Responsible Party):

Antonio M Jimenez Jimenez

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

Condition or disease

Acute Myeloid Leukemia

Intervention/treatment

Venetoclax

Azacitidine

Donor Lymphocyte Infusion

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Study of 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)
Actual Study Start Date : 2024-12-04
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Male and female patients between the ages of 18-75.
  • 2. 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.
  • 3. 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
    • 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    • 5. Serum creatinine =\< 1.5 mg/dL or creatinine clearance greater or equal than 40 cc/min
    • 6. Serum bilirubin =\< 1.5 x upper limit of normal (ULN)
    • 7. Aspartate transaminase (AST) or alanine transaminase (ALT) =\< 2.5 x ULN
    • 8. Alkaline phosphatase =\< 2.5 x UL
    • 9. Negative serum or urine pregnancy test for women with reproductive potential.
    • 10. A negative donor-specific antibody (DSA) assay (i.e., Micro-Flow Imaging (MFI) \
    Exclusion Criteria
    • 1. Active disease (\>5% blasts or any evidence of extra-medullary disease) at the time of transplantation or at day +30
    • 2. Active acute graft-versus-host disease (aGVHD) requiring systemic IST or history of aGVHD grade III or higher.
    • 3. Active chronic GVHD requiring systemic immunosuppressive therapy (IST).
    • 4. Active uncontrolled systemic fungal, bacterial, or viral infection
    • 5. Known active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
    • 6. 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.
    • 7. 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.
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)

Location Details

NCT06158100

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33136