A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Part of paid clinical trials in Los Angeles, California.

Sponsor
AbbVie
Study ID
NCT03441555
Phase
PHASE1
Status
Completed

Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    tablet, oral
  • Alvocidib — DRUG
    Intravenous

Study Details

An open-label, dose-escalation study to assess the safety and pharmacokinetics (PK), to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of alvocidib with venetoclax when co-administered in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML).

Key Dates

Start date
May 30, 2018
Status verified
Jan 2022
Primary completion
Jan 25, 2021
Completion
Jan 25, 2021

Study Design

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

Arms

  • Experimental: Venetoclax + Alvocidib
    Venetoclax administered orally once daily (QD) and Alvocidib administered as an intravenous infusion on Days 1, 2, and 3 for all 28-day treatment cycles. Different combinations of dose levels for venetoclax and alvocidib may be explored.

Primary Outcome Measure

Tmax of venetoclax [ Time Frame: Approximately 32 days after first dose of study drug ]

Locations (9)

FacilityCityStateZIPSite coordinators
USC Norris Cancer Center /ID# 170844Los AngelesCalifornia90033-
UC Irvine /ID# 201093OrangeCalifornia92868-
University of California, Davis Comprehensive Cancer Center /ID# 170799SacramentoCalifornia95817-
Sylvester Comprehensive Cancer /ID# 170761MiamiFlorida33136-1002-
Indiana Blood & Marrow Transpl /ID# 170793IndianapolisIndiana46237-
NYU Langone Medical Center /ID# 201559New YorkNew York10016-6402-
Weill Cornell Medical College /ID# 170800New YorkNew York10021-
Duke University Medical Center /ID# 170842DurhamNorth Carolina27710-3000-
University of Pittsburgh Medic /ID# 170790PittsburghPennsylvania15261-

Find similar trials in Los Angeles, CA

By research site
USC Norris Cancer Center· Los Angeles, CAUC Irvine· Orange, CAUniversity of California, Davis Comprehensive Cancer Center· Sacramento, CASylvester Comprehensive Cancer· Miami, FLIndiana Blood & Marrow Transpl· Indianapolis, INNYU Langone Medical Center· New York, NY

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