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)

Conditions

Acute Myeloid Leukemia Hematopoietic Cell Transplant (HCT)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-12-04

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT06158100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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) \<m3000) for recipients of any mismatched graft (including haploidentical) HCT.	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.

Inclusion Criteria

Exclusion 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) \<m3000) for recipients of any mismatched graft (including haploidentical) HCT.

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.

Contacts and Locations

Principal Investigator

Antonio M Jimenez Jimenez, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: Antonio M Jimenez Jimenez

Antonio M Jimenez Jimenez, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-04

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-12-04

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Hematopoietic Cell Transplant (HCT)

Additional Relevant MeSH Terms

Acute Myeloid Leukemia