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NCT04146038 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2023-05-24

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants Experiencing Adverse Events Incidence With of Salicylate + Venetoclax + Decitabine

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outcome · POSTED

Number of Participants With Complete or Partial Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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. Pregnant patients are excluded * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Salsalate or other agents used in the study. Examples include aspirin * The effects of venetoclax and decitabine or 5-azacytidine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 24 weeks after. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, therefore, known human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with treatment medications or other agents administered during the study
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Azacitidine
    2. Drug: Decitabine
    3. Drug: Salsalate
    4. Drug: Venetoclax
    label
    Treatment (salsalate, decitabine, azacitidine, venetoclax)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (salsalate, decitabine, azacitidine, venetoclax)
    description
    Given IV
    name
    Azacitidine
    other Names
    1. 5 AZC
    2. 5-AC
    3. 5-Azacytidine
    4. 5-AZC
    5. Azacytidine
    6. Azacytidine, 5-
    7. Ladakamycin
    8. Mylosar
    9. U-18496
    10. Vidaza
    type
    DRUG
  2. arm Group Labels
    1. Treatment (salsalate, decitabine, azacitidine, venetoclax)
    description
    Given IV
    name
    Decitabine
    other Names
    1. 5-Aza-2''-deoxycytidine
    2. Dacogen
    3. Decitabine for Injection
    4. Deoxyazacytidine
    5. Dezocitidine
    type
    DRUG
  3. arm Group Labels
    1. Treatment (salsalate, decitabine, azacitidine, venetoclax)
    description
    Given PO
    name
    Salsalate
    other Names
    1. Disalcid
    2. Mono-Gesic
    3. o-Salicylsalicylic Acid
    4. Salflex
    5. Salicylsalicylic Acid
    6. Salsitab
    type
    DRUG
  4. arm Group Labels
    1. Treatment (salsalate, decitabine, azacitidine, venetoclax)
    description
    Given PO
    name
    Venetoclax
    other Names
    1. ABT-0199
    2. ABT-199
    3. ABT199
    4. GDC-0199
    5. RG7601
    6. Venclexta
    7. Venclyxto
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
5
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Study drug associated adverse events during therapy
    measure
    Number of Participants Experiencing Adverse Events Incidence With of Salicylate + Venetoclax + Decitabine
    time Frame
    During the first 2 cycles, 56 days total
secondary Outcomes
  1. description
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
    measure
    Number of Participants With Complete or Partial Response
    time Frame
    During the first 2 cycles 56 days total
Full study description
brief 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.
detailed Description
PRIMARY OBJECTIVE: I. Determine the tolerability of the addition of standard dose salsalate to the standard treatment combination of venetoclax + hypomethylating agent (HMA) (decitabine or azacitidine \[5-azacytidine\]). SECONDARY OBJECTIVES: I. Determine the remission rate and, when feasible, perform exploratory studies of: Ia. Patterns of mutation clearance. Ib. Distribution of cells with low and high reactive oxygen species (ROS) content at various points during therapy. OUTLINE: CYCLE 1: Patients receive salsalate orally (PO) twice daily (BID) until completion of cycle 1. 24-48 hours later or concurrent with salsalate, patients begin to receive decitabine intravenously (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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      clinical indication matching status
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      id
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      link basis
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      nct id
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      occurrences
      1. context exact
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        exact text
        NCT04146038
        start
        0
      offset unit
      unicode_code_points
      query cond
      Juvenile Myelomonocytic Leukemia
      query disease state id
      ds-juvenile-myelomonocytic-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-juvenile-myelomonocytic-leukemia-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      664ef26f5c1f2ce3178f1b3a412fe6a1355b8cfee6e466443915a8c00391f6b7

    Preserved source evidence · Not medical advice