Gemtuzumab Ozogamicin in Treating Patients With Acute Myeloid Leukemia

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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)

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rate of serious adverse events

Secondary Outcome

 Overall response, defined as complete remission (CR) and CR with incomplete platelet recovery (CRp)

Condition

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Intervention

gemtuzumab ozogamicin

Study Arms / Comparison Groups

 Treatment (monoclonal antibody therapy)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

May 2012

Completion Date

September 2013

Primary Completion Date

September 2013

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Leslie Ellis, MD, , 



Administrative Informations


NCT ID

NCT01548911

Organization ID

IRB00019491

Secondary IDs

NCI-2012-00127

Responsible Party

Sponsor

Study Sponsor

Wake Forest University Health Sciences

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Leslie Ellis, MD, Principal Investigator, Wake Forest University Health Sciences


Verification Date

June 2018