Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia (AML)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT04926285
Phase
PHASE1
Status
Completed

Conditions

  • Relapsed or Refractory Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Omacetaxine — DRUG
    Escalating doses of Omacetaxine 0.625 mg/m2 q12h, 1.25 mg/m2 q12h, 2.0 mg/m2 q12h, and 2.5 mg/m2 q12h
  • Venetoclax — DRUG
    Venetoclax at 400mg

Study Details

This will be a single arm, open label Phase Ib dose-escalation study of the combination of VEN and OM, conducted using an innovative Bayesian Optimal Interval-design, to find the MTD in participants with AML failing treatment with venetoclax-containing regimens. Treatment plan will consist of an induction phase, followed by a consolidation phase if applicable.

Key Dates

Start date
Jun 21, 2022
Status verified
Mar 2026
Primary completion
Jan 29, 2024
Completion
Feb 6, 2025

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Omacetaxine 0.625 mg/m2 SQ injection q12h days 1-7 with Venetoclax 400 mg orally daily on days 4-28 Cycles are 28 days
  • Experimental: Cohort 2
    Omacetaxine 1.25 mg/m2 SQ injection q12h days 1-7 with Venetoclax 400 mg orally daily on days 4-28 Cycles are 28 days
  • Experimental: Cohort 3
    Omacetaxine 2.0 mg/m2 SQ injection q12h days 1-7 with Venetoclax 400 mg orally daily on days 4-28 Cycles are 28 days
  • Experimental: Cohort 4
    Omacetaxine 2.5 mg/m2 SQ injection q12h days 1-7 with Venetoclax 400 mg orally daily on days 4-28 Cycles are 28 days

Primary Outcome Measure

To establish the maximum tolerated dose (MTD) of Omacetaxine in combination with Venetoclax [ Time Frame: 42 Days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois Cancer CenterChicagoIllinois60612-

Find similar trials in Chicago, IL

By research site
University of Illinois Cancer Center· Chicago, IL

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