Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia … (NCT04146038) | Clinical Trial Compass
CompletedPhase 2
Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease
United States5 participantsStarted 2020-10-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically proven acute myelogenous leukemia (AML) or advanced myeloid malignancy \[myelodysplasia; chronic myelomonocytic leukemia (CMML); or chronic myeloproliferative disease (MPD) each with \>= 10% myeloblasts in blood or bone marrow\]
* For patients with de novo AML: must not be a candidate for standard induction therapy based upon age, co-morbidities, patient choice, high risk features known to have poor outcomes with standard induction therapy (ELN high risk disease by cytogenetics, deoxyribonucleic acid \[DNA\] mutation profile or TP53 mutation)
* Patients with advanced myelodysplastic syndrome (MDS), secondary AML, relapsed/refractory AML, prior hypomethylating agent are eligible
* Patients must give informed consent
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Total bilirubin \< 2 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 X institutional ULN
* Creatinine \< 2 mg/dL
Exclusion Criteria:
* White blood cell (WBC) uncontrolled (\> 15,000/uL) despite hydroxyurea or cytarabine x 3 days. Known central nervous system (CNS) AML
* Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient?s ability to complete the study, at the discretion of the investigator. P…
What they're measuring
1
Number of Participants Experiencing Adverse Events Incidence With of Salicylate + Venetoclax + Decitabine
Timeframe: During the first 2 cycles, 56 days total
Trial details
NCT IDNCT04146038
SponsorRutgers, The State University of New Jersey