Clinical Trials /

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)

NCT03070093

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Available

Trial Eligibility

Document

Title

  • Brief Title: 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)
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: 2215-CL-9100
  • NCT ID: NCT03070093

Conditions

  • Acute Myeloid Leukemia (AML)
  • FMS-like Tyrosine Kinase-3 (FLT3) Mutations

Interventions

DrugSynonymsArms
gilteritinibASP2215

Purpose

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.

Detailed Description

      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.]
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        Inclusion Criteria:

          -  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:

               -  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.

        Exclusion Criteria:

          -  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.

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:

Details

Phase:
Primary Purpose:Expanded Access
Overall Status:Available
Lead Sponsor:Astellas Pharma Global Development, Inc.

Trial Keywords

  • Acute myeloid leukemia (AML)
  • FMS-like Tyrosine kinase-3 (FLT3) mutations
  • gilteritinib
  • Expanded access
  • ASP2215

Last Updated

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