Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT04146038
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Given IV
  • Decitabine — DRUG
    Given IV
  • Salsalate — DRUG
    Given PO
  • Venetoclax — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Oct 26, 2020
Status verified
Apr 2023
Primary completion
Oct 25, 2021
Completion
Oct 25, 2022

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (salsalate, decitabine, azacitidine, venetoclax)
    CYCLE 1: Patients receive salsalate PO BID until completion of cycle 1. 24-48 hours later or concurrent with salsalate, patients begin to receive decitabine IV for 10 days or azacitidine IV for 7 days. Starting 24 hour after salsalate, patients also receive venetoclax PO continuously until completion of cycle 1. CYCLE 2: Patients receive decitabine IV for 5 days or azacitidine IV for 7 days, salsalate PO BID, and venetoclax PO continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants Experiencing Adverse Events Incidence With of Salicylate + Venetoclax + Decitabine [ Time Frame: During the first 2 cycles, 56 days total ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-

Find similar trials in New Brunswick, NJ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Rutgers Cancer Institute of New Jersey· New Brunswick, NJ

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