Clinical Trials /

Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Participants With Acute Myeloid Leukemia

NCT03737955

Description:

This phase II trial studies how well fractionated gemtuzumab ozogamicin works in treating measurable residual disease in participants with acute myeloid leukemia. Antibody-drug conjugates, such as gemtuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Participants With Acute Myeloid Leukemia
  • Official Title: Fractionated Gemtuzumab Ozogamicin to Eradicate Measurable Residual Disease in Acute Myeloid Leukemia Patients (GO for MRD)

Clinical Trial IDs

  • ORG STUDY ID: RG1018001
  • SECONDARY ID: NCI-2018-01613
  • SECONDARY ID: 9966
  • NCT ID: NCT03737955

Conditions

  • Acute Myeloid Leukemia
  • CD33 Positive
  • Minimal Residual Disease

Interventions

DrugSynonymsArms
Gemtuzumab OzogamicinCDP-771, Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, MylotargTreatment (gemtuzumab ozogamicin)

Purpose

This phase II trial studies how well fractionated gemtuzumab ozogamicin works in treating measurable residual disease in participants with acute myeloid leukemia. Antibody-drug conjugates, such as gemtuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells.

Detailed Description

      Participants receive gemtuzumab ozogamicin intravenously (IV) on days 1, 4, 7. Treatment
      continues for 35 days in the absence of disease progression or unacceptable toxicity.
      Non-responders without significant adverse events during the first course and responders, may
      receive a second course of gemtuzumab ozogamicin within 60 days after course 1.

      After completion of study treatment, participants are followed up for 6 months.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (gemtuzumab ozogamicin)ExperimentalParticipants receive gemtuzumab ozogamicin IV on days 1, 4, 7. Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Non-responders without significant adverse events during the first course and responders, may receive a second course of gemtuzumab ozogamicin within 60 days after course 1.
  • Gemtuzumab Ozogamicin

Eligibility Criteria

        Inclusion Criteria:

          -  Prior diagnosis of AML based on 2016 World Health Organization criteria.

          -  Patients must have MRD-level disease only and otherwise meet criteria for complete
             response (CR) or complete remission with incomplete hematologic recovery (CRi) per the
             2017 European LeukemiaNet response criteria (< 5% blasts in the marrow without a
             requirement for peripheral blood count recovery). MRD must be measurable by
             multiparameter flow cytometry (MPFC) and/or polymerase chain reaction (PCR)-based
             molecular markers and/or karotypic markers (e.g., classical cytogenetics or
             fluorescence in situ hybridization). MRD status will be centrally confirmed by the
             UW/FHCRC clinical laboratory in order to standardize response assessment following
             administration of study therapy.

          -  Patients must have received at least 1-2 cycles of standard induction chemotherapy
             prior to enrollment on the study. However, adult patients (>= 18 years of age) are
             eligible for participation at any time point in treatment (after induction, during or
             after consolidation, pre-transplant, or post-transplant). Pediatric patients (2-18
             years of age) must have MRD positivity during/after consolidation or post-transplant.

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (for adults) or
             Lansky performance status >= 40 (for children).

          -  Patient's AML blasts must have CD33 expression.

          -  For adults (>= 18 years of age): Serum creatinine =< 2.0 mg/dL.

          -  For adults (>= 18 years of age): Total bilirubin =< 2 x institutional upper limit of
             normal for age (unless known history of Gilbert's disease).

          -  For adults (>= 18 years of age): Aspartate aminotransferase (AST) and alanine
             aminotransferase (ALT) < 2.5 fold the institutional upper limit of normal for age
             (unless thought to be related to resolving infectious complications).

          -  For children (< 18 years of age): Glomerular filtration rate (GFR) in ml/min (age 2:
             63-175; age 3-12: 89-165; females 13 and older: 75-115; males 13 and older: 85-125).

          -  For children (< 18 years of age): Total bilirubin =< 2 x institutional upper limit of
             normal for age (unless known history of Gilbert's disease).

          -  For children (< 18 years of age): AST and ALT < 2.5 fold the institutional upper limit
             of normal for age (unless thought to be related to resolving infectious
             complications).

          -  Ability of patient or representative to provide written informed consent.

          -  Females of childbearing potential must have a negative pregnancy test prior to
             receiving GO.

        Exclusion Criteria:

          -  Subjects who have had chemotherapy or radiation therapy within 14 days prior to
             entering the study.

          -  Subjects may not be receiving other investigational agents.

          -  Uncontrolled or concurrent illness including, but not limited to, uncontrolled
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:2 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Clinical response rate
Time Frame:Up to 70 days
Safety Issue:
Description:Measured by clearance of measurable residual disease (MRD) with bone marrow evaluation after one or two cycles of therapy and compare responses (rate of eradication of MRD) based on CD33 SNP rs12459419 genotype.

Secondary Outcome Measures

Measure:Rate of sinusoidal obstructive syndrome (SOS)
Time Frame:Up to 6 months
Safety Issue:
Description:Measured by grade III/IV non-hematologic toxicities using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
Measure:Rate of allogeneic hematopoietic cell transplantation (HCT)
Time Frame:Up to 6 Months
Safety Issue:
Description:Measured by those receiving HCT

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Washington

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