A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT03730012
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Acute Myeloid Leukemia (AML)
  • Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation

Eligibility Criteria

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

Interventions

  • gilteritinib — DRUG
    Oral tablet
  • atezolizumab — DRUG
    Intravenous infusion

Study Details

The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and to determine the composite complete remission (CRc) rate for participants who either discontinued the study or completed 2 cycles of gilteritinib given in combination with atezolizumab. This study also evaluated pharmacokinetics (PK), response to treatment, remission and survival. Adverse events (AEs), clinical laboratory results, vital signs, electrocardiograms (ECGs), and Eastern Cooperative Oncology Group (ECOG) performance status scores were also assessed.

Key Dates

Start date
Jun 19, 2019
Status verified
Nov 2024
Primary completion
May 14, 2021
Completion
Jun 15, 2021

Study Design

Enrollment
11 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gilteritinib 120 mg + Atezolizumab 420 mg
    Participants received 120 milligrams (mg) giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 420 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab).
  • Experimental: Gilteritinib 120 mg + Atezolizumab 840 mg
    Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg administered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab).

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLT) [ Time Frame: Day 1 up to 28 days ]

Locations (12)

FacilityCityStateZIPSite coordinators
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-
Northwestern UniversityChicagoIllinois60611-
University of ChicagoChicagoIllinois60037-
University of KentuckyLexingtonKentucky40536-
Roswell Park Cancer Institute (RPCI)BuffaloNew York14263-
Columbia University Medical CenterNew YorkNew York10032-
Weill Cornell Medical CollegeNew YorkNew York10065-
The Ohio State University Comprehensive Cancer Center (OSUCCC)ColumbusOhio43210-
Vanderbilt Ingram Cancer CenterNashvilleTennessee37232-
Simmons Comprehensive Cancer CenterDallasTexas75390-
University of Texas MD AndersonHoustonTexas77030-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Los Angeles, CA

By research site
Ronald Reagan UCLA Medical Center· Los Angeles, CANorthwestern University· Chicago, ILUniversity of Chicago· Chicago, ILUniversity of Kentucky· Lexington, KYRoswell Park Cancer Institute (RPCI)· Buffalo, NYColumbia University Medical Center· New York, NY

Related Studies