Clinical Trials /

Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML

NCT02109627

Description:

The purpose of this study is to see if ficlatuzumab when combined with cytarabine, a standard treatment for AML, is safe to give to patients and to determine the best dose to give. The study doctors want to see what effects, good and/or bad, the study drug has on subjects and their AML. The study will look at what side effects subjects may have and how subjects feel after receiving the study drug.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML
  • Official Title: Phase Ib Study of Ficlatuzumab With High Dose Cytarabine (HiDAC) in Relapsed and Refractory AML

Clinical Trial IDs

  • ORG STUDY ID: 139510
  • SECONDARY ID: NCI-2015-00749
  • NCT ID: NCT02109627

Conditions

  • Acute Myeloid Leukemia
  • Relapsed Acute Myeloid Leukemia
  • Refractory Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
FiclatuzumabFiclatuzumab, Cytarabine
CytarabineHiDACFiclatuzumab, Cytarabine

Purpose

The purpose of this study is to see if ficlatuzumab when combined with cytarabine, a standard treatment for AML, is safe to give to patients and to determine the best dose to give. The study doctors want to see what effects, good and/or bad, the study drug has on subjects and their AML. The study will look at what side effects subjects may have and how subjects feel after receiving the study drug.

Trial Arms

NameTypeDescriptionInterventions
Ficlatuzumab, CytarabineExperimentalFiclatuzumab 5-20 mg/kg; intravenous; Days 0, 14, 28, 42; Number of cycles: until progression or unacceptable toxicity develops. Cytarabine 2 g/m2; intravenous; Days 2-7; Number of cycles: until progression or unacceptable toxicity develops.
  • Ficlatuzumab
  • Cytarabine

Eligibility Criteria

        Inclusion Criteria:

          -  Relapsed or refractory AML as defined by one of the following criteria:

               1. First relapse within 12 months after date of first CR or CRi

               2. Persistent AML documented by bone marrow biopsy at least 28 days after day 1 of
                  the first induction cycle of cytotoxic chemotherapy

               3. Hypercellular bone marrow with greater than 20% cellularity and 10% blasts at
                  least 14 days after first induction cycle day 1

          -  Age >=18

          -  Prior induction therapy had to include no more than two cycles of cytotoxic
             chemotherapy and at least one induction cycle must have consisted of an anthracycline
             or anthracenedione and cytarabine combination with a reasonable schedule/dose
             according to the discretion of the investigator

          -  Histologically confirmed AML by hematopathology review performed within four weeks
             prior to study entry

          -  Ejection fraction >=40% by transthoracic echocardiogram or radionuclide
             ventriculogram, i.e. MUGA scan

          -  Treatment for non-hematologic malignancy greater than 6 months prior to enrollment is
             acceptable.

          -  Transplantation for AML (allogeneic or autologous) allowed unless within 90 days of
             study entry

          -  No active graft versus host disease (GVHD) or immunosuppression for prevention or
             treatment of GVHD within two weeks of study entry

          -  Prior treatment of myelodysplastic syndrome or myeloproliferative neoplasm with
             hypomethylating agent acceptable.

          -  Cytoreduction therapy with plasmapheresis or hydroxyurea acceptable.

          -  Females must have a negative serum pregnancy test 24 hours prior to the start of
             treatment or be surgically or biologically sterile or postmenopausal (amenorrheic for
             at least 12 months)

          -  Adequate liver function as defined by total bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL for
             patients with known Gilbert's syndrome) and AST/ALT ≤ 3 times upper limit of normal,
             unless these are thought to be due to AML

          -  Adequate renal function with creatinine ≤ 2.0 mg/dL

          -  The effects of ficlatuzumab on the developing human fetus are unknown. For this reason
             and because cytarabine is pregnancy category D, women of child-bearing potential and
             men must agree to use adequate contraception: hormone, barrier method of birth
             control, or abstinence prior to study entry and for the duration of study
             participation. Should a woman become pregnant or suspect she is pregnant while she or
             her partner is participating in this study, she should inform her treating physician
             immediately. Men treated or enrolled on this protocol must also agree to use adequate
             contraception prior to the study, for the duration of study participation, and at
             least one month after completion of study drug administration.

          -  Ability to understand a written informed consent document, and the willingness to sign
             it

        Exclusion Criteria:

          -  Acute promyelocytic leukemia (FAB M3 AML)

          -  More than 2 cycles of prior induction therapy for AML

          -  Allogeneic or autologous transplant for AML with infusion of stem cells within 90 days
             of study entry or on active immunosuppressive therapy for (GVHD) within 2 weeks before
             study entry

          -  Cytarabine containing regimen in excess of 2 g/m2/day within 6 months of study entry

          -  Chemotherapy, radiation, or immunotherapy, within 2 weeks prior to study entry, other
             than those specified in the inclusion criteria (hydroxyurea and hypomethylating
             agents)

          -  Known active HIV, hepatitis B or C or infection. Exception for patients with hepatitis
             B on antivirals and low viral load, to be determined at the discretion of the
             investigator.

          -  Uncontrolled infection

          -  Uncontrolled intercurrent illness or psychiatric illness/social situations that would
             limit compliance with study requirements

          -  Active second malignancy that in the opinion of the PI may interfere with or be
             adversely affected by this treatment.

          -  Prior exposure to the investigational agent or anti-c-Met, anti-HGF or anti-VEGF
             directed therapy within six months prior to study entry

          -  Prior grade 4 toxicity attributed to cytarabine

          -  Known or suspected drug sensitivity to cytarabine or the investigational agent
             ficlatuzumab

          -  Inability to provide consent

          -  Pregnant women are excluded from this study because the effect of ficlatuzumab on the
             developing fetus remains unknown and that cytarabine is a pregnancy risk category D
             drug with known teratogenic or abortifacient effects. Because of the potential adverse
             events in nursing infants secondary to treatment of the mother with ficlatuzumab and
             cytarabine, breastfeeding should be discontinued while on study. Patients who become
             pregnant while on study will be removed from the study once the pregnancy is
             confirmed.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-Limiting Toxicity (DLT) for ficlatuzumab when administered with HiDAC
Time Frame:Up to 2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Preliminary activity of ficlatuzumab in combination with HiDAC in patients with relapsed or refractory AML
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Functional status for patients receiving ficlatuzumab and HiDAC
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Quality of life for patients receiving ficlatuzumab and HiDAC
Time Frame:Up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:C. Babis Andreadis

Trial Keywords

  • Acute Myeloid Leukemia
  • Ficlatuzumab
  • High Dose Cytarabine
  • antibody

Last Updated

August 18, 2019