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Gemtuzumab Ozogamicin in Treating Patients With Acute Myeloid Leukemia

Primary Purpose

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
gemtuzumab ozogamicin
laboratory biomarker analysis
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have confirmed relapsed or refractory acute myeloid leukemia and not a candidate for standard induction treatment after daunorubicin and cytosine arabinoside OR acute promyelocytic leukemia relapsed after all-trans retinoic acid (ATRA) or Arsenic trioxide therapy
  • Patients must have an initial diagnosis of acute myeloid leukemia or biphenotypic acute leukemia
  • Patients must have CD33 positivity of >= 30%
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 3
  • Karnofsky > 60%
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2 X institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • The effects of Mylotarg on the developing human fetus are unknown; for this reason and because Mylotarg class agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents for leukemia
  • Patients with known untreated Hepatitis C because veno-occlusive disease and liver enzyme abnormalities have been associated with Mylotarg
  • Uncontrolled intercurrent illness including, but not limited to active liver disease, ongoing or active sepsis requiring vasopressors or mechanical ventilation, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because Mylotarg is a Class D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Mylotarg, breastfeeding should be discontinued if the mother is treated with Mylotarg
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Mylotarg; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
  • Congestive Heart Failure (CHF) with an ejection fraction < 30%
  • Glomerular filtration rate (GFR) < 30ml/min
  • Active central nervous system (CNS) involvement of leukemia
  • Philadelphia chromosome + acute lymphoblastic leukemia (ALL)
  • Prior hematopoietic transplant in last 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment (monoclonal antibody therapy)

    Arm Description

    Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity.

    Outcomes

    Primary Outcome Measures

    Rate of serious adverse events
    95% confidence interval will be calculated. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Secondary Outcome Measures

    Overall response, defined as complete remission (CR) and CR with incomplete platelet recovery (CRp)
    Safety analysis of gemtuzumab ozogamicin as induction therapy for patients with relapsed AML
    Adverse event frequency and severity
    Overall survival (OS)
    Event-free survival (EFS)
    Disease free survival (DFS)

    Full Information

    First Posted
    February 14, 2012
    Last Updated
    June 29, 2018
    Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01548911
    Brief Title
    Gemtuzumab Ozogamicin in Treating Patients With Acute Myeloid Leukemia
    Official Title
    Safety and Efficacy of Gemtuzumab Ozogamicin (Mylotarg®) as for Treatment of Patients With CD33-Positive Acute Myeloid Leukemia (AML)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This clinical trial studies the side effects of gemtuzumab ozogamicin and how well it works in treating patients with acute myeloid leukemia. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them
    Detailed Description
    PRIMARY OBJECTIVES: I. To study safety and efficacy single agent Gemtuzumab Ozogamicin (Mylotarg®) as induction therapy for patients with Acute Myeloid Leukemia (AML) who have relapsed after standard treatments or who are not candidates for standard consolidation treatment after Daunorubicin and cytosine arabinoside. SECONDARY OBJECTIVES: I. To correlate morbidity and mortality with the use of gemtuzumab (gemtuzumab ozogamicin) to specific subtypes of leukemia. II. To correlate gemtuzumab response to degree of cluster of differentiation (CD) 33 positivity. III. To correlate FMS-Related Tyrosine Kinase 3 (FLT 3)/nucleophosmin (NPM) status and CD 33 positivity to gemtuzumab response. IV. To document incidence of sinusoidal obstruction syndrome with the use of gemtuzumab. OUTLINE: Patients receive gemtuzumab ozogamicin intravenously (IV) over 2 hours on days 1 and 15. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up monthly for 1 year.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Promyelocytic Leukemia (M3), Recurrent Adult Acute Myeloid Leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment (monoclonal antibody therapy)
    Arm Type
    Experimental
    Arm Description
    Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity.
    Intervention Type
    Drug
    Intervention Name(s)
    gemtuzumab ozogamicin
    Other Intervention Name(s)
    Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, CDP-771, CMA-676, Mylotarg
    Intervention Description
    Given IV
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Intervention Description
    Correlative studies
    Primary Outcome Measure Information:
    Title
    Rate of serious adverse events
    Description
    95% confidence interval will be calculated. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
    Time Frame
    Approximately 1 year
    Secondary Outcome Measure Information:
    Title
    Overall response, defined as complete remission (CR) and CR with incomplete platelet recovery (CRp)
    Time Frame
    At 28 days
    Title
    Safety analysis of gemtuzumab ozogamicin as induction therapy for patients with relapsed AML
    Description
    Adverse event frequency and severity
    Time Frame
    Approximately 1 year
    Title
    Overall survival (OS)
    Time Frame
    Approximately 1 year
    Title
    Event-free survival (EFS)
    Time Frame
    Approximately 1 year
    Title
    Disease free survival (DFS)
    Time Frame
    Approximately 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have confirmed relapsed or refractory acute myeloid leukemia and not a candidate for standard induction treatment after daunorubicin and cytosine arabinoside OR acute promyelocytic leukemia relapsed after all-trans retinoic acid (ATRA) or Arsenic trioxide therapy Patients must have an initial diagnosis of acute myeloid leukemia or biphenotypic acute leukemia Patients must have CD33 positivity of >= 30% Eastern Cooperative Oncology Group (ECOG) performance status =< 3 Karnofsky > 60% Total bilirubin within normal institutional limits Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2 X institutional upper limit of normal Creatinine within normal institutional limits OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal The effects of Mylotarg on the developing human fetus are unknown; for this reason and because Mylotarg class agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Patients may not be receiving any other investigational agents for leukemia Patients with known untreated Hepatitis C because veno-occlusive disease and liver enzyme abnormalities have been associated with Mylotarg Uncontrolled intercurrent illness including, but not limited to active liver disease, ongoing or active sepsis requiring vasopressors or mechanical ventilation, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study because Mylotarg is a Class D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Mylotarg, breastfeeding should be discontinued if the mother is treated with Mylotarg Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Mylotarg; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated Congestive Heart Failure (CHF) with an ejection fraction < 30% Glomerular filtration rate (GFR) < 30ml/min Active central nervous system (CNS) involvement of leukemia Philadelphia chromosome + acute lymphoblastic leukemia (ALL) Prior hematopoietic transplant in last 3 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leslie Ellis, MD
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Gemtuzumab Ozogamicin in Treating Patients With Acute Myeloid Leukemia

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