A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia
NCT ID: NCT03625505
Last Updated: 2021-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2018-10-18
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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).
Venetoclax
tablet, oral
Gilteritinib
tablet, oral
Dose Expansion Venetoclax + Gilteritinib
Participants will receive venetoclax in combination with gilteritinib at the dose determined in dose escalation portion.
Venetoclax
tablet, oral
Gilteritinib
tablet, oral
Interventions
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Venetoclax
tablet, oral
Gilteritinib
tablet, oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Should have failed at least 1 line of prior therapy (defined as failure to respond to therapy, and/or progression during or after therapy).
* Should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Should have adequate hematologic, kidney and liver function as described in the protocol.
* For participants enrolling into the Expansion Cohort only: a documented FMS-like Tyrosine Kinase (FLT3) mutation in bone marrow or peripheral blood, as described in the protocol.
Exclusion Criteria
* Has a history of other malignancies within 2 years prior to study entry, with exceptions as described in the protocol.
* Has active central nervous system leukemia.
* Has a history of chronic New York Heart Association (NYHA) class IV heart failure.
* Has a corrected QT interval of \> 450 ms.
* Has a chronic respiratory disease that requires continuous oxygen use.
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Genentech, Inc.
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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David Geffen School of Medicin /ID# 200166
Los Angeles, California, United States
UC San Francisco Medical Center-Parnassus /ID# 200205
San Francisco, California, United States
Sylvester Comprehensive Cancer /ID# 200268
Miami, Florida, United States
Northwestern Memorial Hospital /ID# 200230
Chicago, Illinois, United States
Norton Cancer Institute /ID# 200623
Louisville, Kentucky, United States
Johns Hopkins University /ID# 200349
Baltimore, Maryland, United States
Mayo Clinic - Rochester /ID# 200346
Rochester, Minnesota, United States
Hackensack Univ Med Ctr /ID# 200229
Hackensack, New Jersey, United States
Weill Cornell Medical College /ID# 200109
New York, New York, United States
Hosp of the Univ of Penn /ID# 200348
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 206686
Houston, Texas, United States
Countries
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References
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Daver N, Perl AE, Maly J, Levis M, Ritchie E, Litzow M, McCloskey J, Smith CC, Schiller G, Bradley T, Tiu RV, Naqvi K, Dail M, Brackman D, Siddani S, Wang J, Chyla B, Lee P, Altman JK. Venetoclax Plus Gilteritinib for FLT3-Mutated Relapsed/Refractory Acute Myeloid Leukemia. J Clin Oncol. 2022 Dec 10;40(35):4048-4059. doi: 10.1200/JCO.22.00602. Epub 2022 Jul 18.
Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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M16-802
Identifier Type: -
Identifier Source: org_study_id
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