Study of Venetoclax in Combination With Decitabine in Subjects With Acute Myeloid Leukemia

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT03844815
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Decitabine — DRUG
    Decitabine will be administered intravenously at a dose of 20mg per day for 10 days during Cycle 1 (28 day cycle) Decitabine will be administered intravenously at a dose of 20mg per day for 10 days of Cycle 2 (28 day cycle). Decitabine will be administered intravenously at a dose of 20mg per day for 5 days of each 28 day maintenance cycle
  • Venetoclax — DRUG
    Venetoclax administered orally on days 1-21 of cycle 1, cycle 2 and maintenance (28 day cycles). Dose levels will be assigned at time of enrollment anywhere from 100mg-400mg. Dose escalation will follow the 3+3 study design.

Study Details

The main purpose of this study is to learn about the safety and tolerability of an experimental drug, Venetoclax, when it is given along with Decitabine in subjects diagnosed with acute myeloid leukemia (AML).

Key Dates

Start date
Nov 18, 2019
Status verified
Mar 2026
Primary completion
Dec 10, 2027
Completion
Dec 10, 2027

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Cycle 1 of Treatment will be Decitabine days 1-10 plus Venetoclax ramp up on days 1-3 followed by Venetoclax target dose on days 4-21 Cycle 2 of Treatment will be Decitabine days 1-10 plus Venetcolax target dose days 1-21 During maintenance Decitabine on days 1-5 plus Venetoclax days 1-21

Primary Outcome Measure

The rate of dose limiting toxicity (DLT) [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637-

Find similar trials in Chicago, IL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University Of Chicago Medicine Comprehensive Cancer Center· Chicago, IL

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