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

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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