A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia

Part of paid clinical trials in Los Angeles, California.

Sponsor
AbbVie
Study ID
NCT03625505
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
  • Gilteritinib — DRUG
    tablet, oral

Study Details

A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy.

Key Dates

First listed
Aug 10, 2018
Start date
Oct 18, 2018
Status verified
Sep 2021
Primary completion
Aug 31, 2021
Completion
Aug 31, 2021

Study Design

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

Arms

  • Experimental: Dose Escalation Venetoclax + Gilteritinib
    Different combinations of dose levels for venetoclax in combination with gilteritinib will be administered to determine the recommended phase 2 dose (RPTD).
  • Experimental: Dose Expansion Venetoclax + Gilteritinib
    Participants will receive venetoclax in combination with gilteritinib at the dose determined in dose escalation portion.

Primary Outcome Measure

Recommended Phase 2 Dose (RPTD) of Co-administered Study Drugs [ Time Frame: Up to approximately 6 months after the last participant is enrolled ]

Locations (11)

FacilityCityStateZIPSite coordinators
David Geffen School of Medicin /ID# 200166Los AngelesCalifornia90095-
UC San Francisco Medical Center-Parnassus /ID# 200205San FranciscoCalifornia94143-2202-
Sylvester Comprehensive Cancer /ID# 200268MiamiFlorida33136-1002-
Northwestern Memorial Hospital /ID# 200230ChicagoIllinois60611-2927-
Norton Cancer Institute /ID# 200623LouisvilleKentucky40202-3700-
Johns Hopkins University /ID# 200349BaltimoreMaryland21287-
Mayo Clinic - Rochester /ID# 200346RochesterMinnesota55905-0001-
Hackensack Univ Med Ctr /ID# 200229HackensackNew Jersey07601-
Weill Cornell Medical College /ID# 200109New YorkNew York10065-
Hosp of the Univ of Penn /ID# 200348PhiladelphiaPennsylvania19104-
MD Anderson Cancer Center at Texas Medical Center /ID# 206686HoustonTexas77030-4000-

Find similar trials in Los Angeles, CA

By research site
David Geffen School of Medicin· Los Angeles, CAUC San Francisco Medical Center-Parnassus· San Francisco, CASylvester Comprehensive Cancer· Miami, FLNorthwestern Memorial Hospital· Chicago, ILNorton Cancer Institute· Louisville, KYJohns Hopkins University· Baltimore, MD

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