A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
AbbVie
Study ID
NCT02287233
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • AML
  • Acute Myelogenous Leukemia

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Venetoclax will be taken orally once daily.
  • Cytarabine — DRUG
    Low-dose cytarabine will be administered subcutaneously on Days 1 to 10 of each 28-day cycle.

Study Details

This study consists of two parts: A Phase 1 dose-escalation part that will evaluate the safety and pharmacokinetic profile of venetoclax in combination with low-dose cytarabine (LDAC), define the maximum tolerated dose (MTD), and generate data to support a recommended Phase 2 dose (RPTD) in treatment-naïve participants with acute myelogenous leukemia (AML); and a Phase 2 part that will evaluate if the RPTD has sufficient efficacy and acceptable toxicity to warrant further development of the combination therapy.

Key Dates

Start date
Dec 31, 2014
Status verified
Aug 2022
Primary completion
Aug 10, 2021
Completion
Aug 10, 2021

Study Design

Enrollment
94 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: 600 mg Venetoclax + LDAC
    Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
  • Experimental: Phase 1: 800 mg Venetoclax + LDAC
    Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
  • Experimental: Phase 2: 600 mg Venetoclax + LDAC
    Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Primary Outcome Measure

Phase 1: Number of Participants With Dose-limiting Toxicities [ Time Frame: Up to 28 days (Cycle 1) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Univ Kansas Med Ctr /ID# 131175Kansas CityKansas66160-
Weill Cornell Medical College /ID# 131170New YorkNew York10065-
University of Pittsburgh MC /ID# 131168PittsburghPennsylvania15260-
Vanderbilt University Medical Center /ID# 131177NashvilleTennessee37232-0011-
Fred Hutchinson Cancer Research Center /ID# 131178SeattleWashington98109-1024-

Find similar trials in Kansas City, KS

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Univ Kansas Med Ctr· Kansas City, KSWeill Cornell Medical College· New York, NYUniversity of Pittsburgh MC· Pittsburgh, PAVanderbilt University Medical Center· Nashville, TNFred Hutchinson Cancer Research Center· Seattle, WA

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