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Acute Myeloid Leukemia (AML)NCT03070093

Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

A study testing gilteritinib in people with Acute Myeloid Leukemia (AML) and FMS-like Tyrosine Kinase-3 (FLT3) Mutations, run by Astellas Pharma Global Development, Inc. at 39 sites in 3 countries.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission [CR], complete remission with incomplete hematologic recovery [CRi], complete remission with incomplete platelet… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gilteritinib
Type of treatment
Pill or oral medicine
How many people
Not given
Where
39 sitesin 3 countries
Study dates
Start not givento not given
Phase
Expanded access

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • Subject is considered an adult according to local regulation at the time of signing informed consent.
  • Subject has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) or therapy-related AML according to World Health Organization (WHO) classification.
  • Subject has presence of the FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD in bone marrow or peripheral blood. [Specific to investigational sites in Japan: FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD subjects will not be included.]
  • Subject has refractory or relapsed AML (with or without hematopoietic stem cell transplant [HSCT]) or AML in CRc (CR, CRi, CRp) with MRD by flow cytometry or genetic testing for the FLT3 mutation after induction/consolidation regimen or HSCT. [Specific to investigational sites in Japan: FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD subjects will not be included.]
  • Subject must wait for at least 5 half-lives after stopping therapy with any investigational agent and before starting ASP2215.
  • Subject must meet the following criteria as indicated on clinical laboratory tests:
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  • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x institutional upper limit of normal (ULN)
  • Serum total bilirubin ≤ 2.5 mg/dL, except for subjects with Gilbert's syndrome
  • Serum potassium and serum magnesium ≥ institutional lower limit of normal (LLN).
  • Subject is able to tolerate oral administration of study drug.
  • Subject who has developed overall grades II-IV acute graft-versus-host disease (GVHD) must satisfy the following criteria:
  • No requirement of > 0.5 mg/kg of prednisone (or equivalent) daily dose within 1 week of enrollment
  • No escalation of immunosuppression in terms of increase of corticosteroids or addition of new agent/modality in prior 2 weeks (note that increasing calcineurin inhibitors or sirolimus to achieve therapeutic trough levels is allowed)
  • Female subject must either:
  • Be of nonchildbearing potential:
  • Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
  • Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 1 month prior to screening.
  • Or, if of childbearing potential,
  • Agree not to try to become pregnant during the study and for at least 180 days after the final study drug administration
  • And have a negative urine pregnancy test at screening
  • And, if heterosexually active, agree to use consistently 2 forms of effective contraception per locally accepted standards (1 of which must be a barrier method) starting at screening and throughout the study period and for at least 180 days after the final study drug administration.
  • Female subject must agree not to breastfeed or donate ova starting at screening and throughout the study period, and for at least 180 days after the final study drug administration.
  • Male subject (even if surgically sterilized) and partners who are women of childbearing potential must agree to practice 2 forms of effective contraception per locally accepted standards
  • (1 of which must be a barrier method), starting at screening and throughout the study period and for 120 days after the final study drug administration.
  • Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.
  • Subject agrees not to participate in another interventional study for AML while on treatment.
  • Subject who has a diagnosis of HIV may be enrolled as long as the disease is under control on antiretroviral therapy. Precautions should be taken to modify highly active antiretroviral therapy (HAART) regimen to minimize drug interactions.
  • There is no comparable or satisfactory alternative therapy to treat the subject's AML.

Who cannot join

  • Subject is eligible to participate in an ongoing clinical study of ASP2215; or has previously participated in a randomized clinical study of ASP2215 with a primary endpoint of overall survival that is not closed for efficacy.
  • Subject with QTcF > 450 ms at screening based on local reading.
  • Subject with a known history of Long QT Syndrome at screening.
  • Subject was diagnosed with acute promyelocytic leukemia (APL).
  • Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
  • Subject has clinically significant coagulation abnormality unless secondary to AML.
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  • Subject has active hepatitis B or C or an active hepatic disorder.
  • Subject has uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, or New York Heart Association (NYHA) Class IV heart failure.
  • Subject requires treatment with concomitant drugs that are strong inducers of CYP3A.
  • Subject has any condition which makes the subject unsuitable for study participation.
  • Subject has hypersensitivity to any of the study drug components.

Trial locations and contacts

39 sites in 3 countries.

39 sites in 3 countries

United States32 sites

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87106

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • Rocky Mountain Cancer Center-M

    Aurora, Colorado, 80012

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • The Sidney Kimmel Comprehensive Cancer Center -Johns Hopkins University

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Northwestern University Medical Center

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • Ohio State University

    Columbus, Ohio, 43210

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Indiana Blood and Marrow Transplantation at Franciscan Health Indianapolis

    Indianapolis, Indiana, 45237

  • West Michigan Regional Cancer Center

    Kalamazoo, Michigan, 49007

  • UCLA

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • WVU Medicine Cancer

    Morgantown, West Virginia, 26506

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Tulane University

    New Orleans, Louisiana, 70112

  • Memorial Sloan Kettering

    New York, New York, 10021

  • Weill Cornell Medical College

    New York, New York, 10065

  • Memorial Healthcare System

    Pembroke Pines, Florida, 33028

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19066

  • UPCI

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Huntsman Cancer Institute University of Utah

    Salt Lake City, Utah, 84112

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Wake Forest Baptist Hospital

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada4 sites

  • Site CA15002

    Halifax, Nova Scotia

  • Site CA15001

    Montreal, Quebec, H1T 2M4

  • Site CA15003

    Toronto, Ontario

  • Site CA15005

    Vancouver

Other trials in Canada

Japan3 sites

  • Site JP81003

    Fukuoka

  • Site JP81001

    Nagoya, Aichi-ken

  • Site JP81002

    Shinagawa-ku, Tokyo

Other trials in Japan

About this study

Official title: A Multicenter, Open-label Treatment Protocol of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission [CR], complete remission with incomplete hematologic recovery [CRi], complete remission with incomplete platelet recovery [CRp]) with MRD without access to comparable or alternative therapy.

Read the detailed description

The United States Food and Drug Administration (FDA), the Japanese Ministry of Health, Labour and Welfare (MHLW) and Health Canada have approved ASP2215/Gilteritinib (XOSPATA®) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.

This treatment protocol is being conducted while phase 3 ASP2215 studies are ongoing in FLT3-mutated AML subjects.

Subjects will complete visits on cycle 1 - days 1, 4, 8, 15; cycle 2 - days 1, 15; cycles 3 to 6 - day 1; and day 1 of every 2 cycles thereafter (i.e., cycle 8 day 1, cycle 10 day 1, etc.) until discontinued from the study.

Subjects will be provided with study medication until the investigator determines the subject is no longer receiving clinical benefit.

An end of treatment visit will be performed within 7 days after last dose of investigational product (ASP2215), or prior to initiation of another anticancer therapy, whichever occurs earlier, followed by a 30-day follow-up. [Specific to investigational sites in Japan: Study population does not include subjects with FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD. Hence, efficacy (MRD response rate and duration of response) data will not be collected for subjects enrolled in Japan.]

Being tested
gilteritinib
Keywords
Acute myeloid leukemia (AML), FMS-like Tyrosine kinase-3 (FLT3) mutations, gilteritinib, Expanded access, ASP2215
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gilteritinibDrug

    Also called ASP2215

    oral

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT03070093
Sponsor's protocol ID
2215-CL-9100
Status last verified
Apr 2021
First submitted
28 Feb 2017
Last updated
20 Apr 2021
Results posted
No

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