COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00049179
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 6, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with cytarabine in treating patients who have relapsed acute myeloid leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Drug: cytarabine Drug: gemtuzumab ozogamicin Phase 2

Detailed Description:


  • Determine the safety and efficacy of gemtuzumab ozogamicin and cytarabine in patients with relapsed acute myeloid leukemia.
  • Determine the frequency and severity of toxic effects of this regimen in CD33-positive patients.
  • Determine, preliminarily, the prognostic significance of drug resistance phenotype, cytogenetics, and molecular genetic characteristics of patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Induction: Patients receive gemtuzumab ozogamicin IV over at least 2 hours on days 1 and 8 and cytarabine IV continuously over days 1-7.
  • Consolidation: Beginning between days 28 and 75, patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status receive one course of gemtuzumab ozogamicin and cisplatin as in induction chemotherapy.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 10-28 months.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)
Study Start Date : April 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : October 2010

Intervention Details:
  • Drug: cytarabine
    ind and consol: 200 mg/m2/d continuous IV days 1-7
  • Drug: gemtuzumab ozogamicin
    ind and consol: 6 mg/m2 IV over 2 hrs day 1, 4mg/m2 IV over 2 hrs day 8

Primary Outcome Measures :
  1. CR [ Time Frame: After induction therapy is completed ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed acute myeloid leukemia (AML)

    • FAB M1-2 or M4-7
    • No blastic transformation of chronic myelogenous leukemia
  • In first relapse after prior complete response

    • Patients who relapsed after autologous or allogeneic bone marrow or peripheral blood stem cell transplantation are not eligible
  • CD33 positive
  • Prior myelodysplastic syndromes or secondary AML allowed
  • Concurrent enrollment on SWOG-9007 (cytogenetics protocol)
  • No clinical or documented CNS involvement with AML



  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


  • WBC no greater than 30,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 1.5 times ULN


  • Not specified


  • No unstable cardiac arrhythmias
  • No unstable angina


  • HIV negative
  • No other malignancy within the past 5 years except for the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix
    • Adequately treated stage I or II cancer currently in complete remission
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy

  • See Disease Characteristics
  • No prior gemtuzumab ozogamicin for AML


  • Prior hydroxyurea to control high cell counts allowed

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • At least 4 weeks since prior investigational agents and recovered

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00049179

Show Show 151 study locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: John E. Godwin, MD, MS Loyola University
Layout table for additonal information
Responsible Party: Southwest Oncology Group Identifier: NCT00049179    
Other Study ID Numbers: S0117
S0117 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by Southwest Oncology Group:
adult acute monocytic leukemia (M5b)
adult acute erythroid leukemia (M6)
adult acute megakaryoblastic leukemia (M7)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
recurrent adult acute myeloid leukemia
secondary acute myeloid leukemia
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological