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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT03625505

Public ClinicalTrials.gov record NCT03625505. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:02 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03625505
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
AbbVie
Industry
Enrollment
61 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 17, 2018
Primary completion
Aug 30, 2021
Completion
Aug 30, 2021
Last update posted
Sep 13, 2021

2018 – 2021

United States locations

U.S. sites
11
U.S. states
10
U.S. cities
11
Facility City State ZIP Site status
David Geffen School of Medicin /ID# 200166 Los Angeles California 90095
UC San Francisco Medical Center-Parnassus /ID# 200205 San Francisco California 94143-2202
Sylvester Comprehensive Cancer /ID# 200268 Miami Florida 33136-1002
Northwestern Memorial Hospital /ID# 200230 Chicago Illinois 60611-2927
Norton Cancer Institute /ID# 200623 Louisville Kentucky 40202-3700
Johns Hopkins University /ID# 200349 Baltimore Maryland 21287
Mayo Clinic - Rochester /ID# 200346 Rochester Minnesota 55905-0001
Hackensack Univ Med Ctr /ID# 200229 Hackensack New Jersey 07601
Weill Cornell Medical College /ID# 200109 New York New York 10065
Hosp of the Univ of Penn /ID# 200348 Philadelphia Pennsylvania 19104
MD Anderson Cancer Center at Texas Medical Center /ID# 206686 Houston Texas 77030-4000

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03625505, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 13, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03625505 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →