Clinical Trials /

Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia

NCT01869803

Description:

This clinical trial studies gemtuzumab ozogamicin in treating patients with relapsed or refractory acute myeloid leukemia or acute promyelocytic 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.

Related Conditions:
  • Acute Biphenotypic Leukemia
  • Acute Myeloid Leukemia
  • Acute Promyelocytic Leukemia
Recruiting Status:

Approved for marketing

Trial Eligibility

Document

Title

  • Brief Title: Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia
  • Official Title: Compassionate Use of Gemtuzumab Ozogamicin (Mylotarg) for Treatment of Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML) or Acute Promyelocytic Leukemia (APL)

Clinical Trial IDs

  • ORG STUDY ID: CCCWFU# 99213
  • SECONDARY ID: NCI-2013-00965
  • SECONDARY ID: P30CA012197
  • NCT ID: NCT01869803

Conditions

  • 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)
  • Childhood Acute Promyelocytic Leukemia (M3)
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
gemtuzumab ozogamicinCalicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, CDP-771, CMA-676, Mylotarg

Purpose

This clinical trial studies gemtuzumab ozogamicin in treating patients with relapsed or refractory acute myeloid leukemia or acute promyelocytic 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 provide patients with acute myeloid leukemia (AML) or acute promyelocytic leukemia
      (APL), who have relapsed or who are refractory to standard treatments, with access to
      gemtuzumab ozogamicin (Mylotarg) when no other comparable or satisfactory alternative therapy
      is available.

      II. To carefully monitor safety and to report safety information from patients receiving
      Mylotarg in this setting.

      OUTLINE:

      Patients receive gemtuzumab ozogamicin intravenously (IV) over 2 hours on days 1 and 15.

      After completion of study treatment, patients are followed up every month for 1 year.
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of relapsed or refractory AML and not candidate for standard consolidation
             treatment after daunorubicin and cytosine arabinoside OR diagnosis of APL relapsed
             after tretinoin (ATRA) and arsenic trioxide therapy or APL with persisting or rising
             blasts, and no other comparable or satisfactory alternative therapy available
             (including patients not eligible for, or who have access to, investigational therapies
             via a clinical trial)

          -  Patients must have an initial diagnosis of AML, biphenotypic acute leukemia, or APL

          -  Patients must have cluster of differentiation (CD)33 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 glutamate pyruvate transaminase [SGPT])
             =< 2 x institutional upper limit of normal

          -  It is deemed ethical to provide an experimental drug (e.g., Mylotarg) that is
             associated with hepatotoxicity (veno-occlusive disease [VOD]) and myelosuppression

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to receiving Mylotarg
             and for the duration of treatment; should a woman become pregnant or suspect she is
             pregnant while receiving treatment with Mylotarg, she should inform her treating
             physician immediately

          -  Ability to understand and the willingness to sign a written Institutional Review Board
             (IRB)-approved informed consent document

        Exclusion Criteria:

          -  Patients may not currently be receiving any other investigational agents for leukemia

          -  Patients with known untreated hepatitis C

          -  Uncontrolled intercurrent illness including, but not limited to active liver disease,
             or psychiatric illness/social situations that would limit compliance with study
             requirements

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with Mylotarg

          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy are ineligible; appropriate studies will be undertaken in patients receiving
             combination antiretroviral therapy when indicated

          -  Patients with a known hypersensitivity to gemtuzumab ozogamicin or its parts:
             recombinant humanized anti-CD33 monoclonal (hP67.6) antibody, calicheamicin
             derivatives or other ingredients
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Details

Phase:
Primary Purpose:Expanded Access
Overall Status:Approved for marketing
Lead Sponsor:Wake Forest University Health Sciences

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