Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease
NCT04146038 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2023-05-24
Summary
This phase II trial studies the side effects of salsalate when added to venetoclax and decitabine or azacitidine in treating patients with acute myeloid leukemia or myelodysplasia/myeloproliferative disease that has spread to other places in the body (advanced). Drugs used in chemotherapy, such as salsalate, venetoclax, decitabine, and azacitidine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Conditions
- Acute Myeloid Leukemia
- Chronic Myelomonocytic Leukemia
- Myeloblasts 10 Percent or More of Bone Marrow Nucleated Cells
- Myelodysplastic Syndrome
- Myeloproliferative Neoplasm
- Recurrent Acute Myeloid Leukemia
- Refractory Acute Myeloid Leukemia
- Secondary Acute Myeloid Leukemia
Interventions
- DRUG
-
Given IV
- DRUG
-
Decitabine
Given IV
- DRUG
-
Salsalate
Given PO
- DRUG
-
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Rutgers, The State University of New Jersey
lead OTHER
Principal Investigators
-
Roger K Strair · Rutgers Cancer Institute of New Jersey
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-26
- Primary Completion
- 2021-10-25
- Completion
- 2022-10-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
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