STAT Inhibitor OPB-111077, Decitabine and Venetoclax in Treating Patients With Acute Myeloid Leukemia That Is Refractory, Relapsed or Newly Diagnosed and Ineligible for Intensive Chemotherapy

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT03063944
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • STAT Inhibitor OPB-111077 — DRUG
    Given PO
  • Decitabine — DRUG
    Given IV
  • Venetoclax — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of STAT inhibitor OPB-111077 when given together with decitabine and venetoclax in treating patients with acute myeloid leukemia that does not respond to treatment (refractory), has come back (relapsed), or is newly diagnosed and ineligible for intensive chemotherapy. STAT inhibitor OPB-111077 and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as venetoclax, 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. Giving STAT inhibitor OPB-111077, decitabine, and venetoclax may work better in treating patients with acute myeloid leukemia compared to decitabine alone.

Key Dates

Start date
Mar 17, 2017
Status verified
May 2025
Primary completion
Jan 18, 2024
Completion
Mar 4, 2024

Study Design

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

Arms

  • Experimental: Treatment (STAT inhibitor OPB-111077, venetoclax, decitabine)
    INDUCTION CYCLE 1: Patients receive STAT inhibitor OPB-111077 PO QD on days 1-28, and venetoclax PO QD on days 4-28 of cycle 1. Patients also receive decitabine IV over approximately 1 hour on days 4-8 of cycle 1. Patients who achieve complete remission (CR) after 1 cycle move on to Maintenance, and patients who do not achieve a CR move on to Cycle 2. INDUCTION CYCLE 2: Patients receive STAT inhibitor OPB-111077, venetoclax, and decitabine as in Induction Cycle 1. Patients who achieve CR, CRi, PR, or stable disease (or clinically significant hematologic improvement as determined by the investigator) move on to Maintenance. MAINTENANCE: Patients receive STAT inhibitor OPB-111077, venetoclax, and decitabine as in Induction Cycle 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of grade 4, non-hematologic dose limiting toxicities assessed by National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0 [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19171-

Find similar trials in Philadelphia, PA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

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