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Gemtuzumab Ozogamicin and Cyclosporine in Treating Older 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: NCT00089050
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : November 30, 2011
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

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. Cyclosporine may increase the effectiveness of gemtuzumab ozogamicin by making cancer cells more sensitive to the drug. Combining gemtuzumab ozogamicin with cyclosporine may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemtuzumab ozogamicin together with cyclosporine works in treating older patients with relapsed acute myeloid leukemia.

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

Detailed Description:



  • Determine the efficacy of gemtuzumab ozogamicin and cyclosporine, in terms of the complete remission rate, in older patients with relapsed acute myeloid leukemia.
  • Determine the toxicity and pharmacokinetics of this regimen in these patients.


  • Correlate clinical response with laboratory studies of drug susceptibility in patients treated with this regimen.

OUTLINE: Patients receive cyclosporine IV continuously over 72 hours on days 1-3 and 15-17. Eight hours after initiation of each cyclosporine infusion, patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3 years.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60
Study Start Date : May 2004
Actual Study Completion Date : March 2006

Primary Outcome Measures :
  1. Efficacy in terms of complete remission rate
  2. Toxicity
  3. Pharmacokinetics

Secondary Outcome Measures :
  1. Correlate clinical response to laboratory studies of drug susceptibility

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.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate

    • More than 20% blasts by morphologic criteria
    • Relapsed disease ≥ 3 months after prior complete remission
  • Blasts CD33-positive by flow cytometry
  • No primary hematologic disorder that preceded initial presentation with AML
  • No documented secondary AML related to prior chemotherapy or toxin exposure
  • No acute promyelocytic leukemia (FAB M3)
  • Not a candidate for transplant therapy
  • No active CNS leukemia



  • 60 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • WBC ≤ 30,000/mm^3 (hydroxyurea allowed)


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 1.5 times ULN


  • Creatinine ≤ 1.5 mg/dL


  • HIV negative
  • No uncontrolled infection


Biologic therapy

  • Not planning hematopoietic stem cell transplantation immediately after study therapy


  • See Disease Characteristics
  • See Hematopoietic

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • More than 1 month since prior investigational agents
  • No other concurrent anticancer therapy
  • No administration of any of the following for 24 hours after cyclosporine administration:

    • Diltiazem
    • Verapamil
    • Erythromycin
    • Clarithromycin
    • Metoclopramide
    • Phenytoin
    • Rifampin
    • Phenobarbital
    • Aminoglycosides
    • Amphotericin B
    • Vancomycin
    • Cimetidine
    • Ranitidine
    • Trimethoprim/sulfamethoxazole
    • Ketoconazole
    • Fluconazole
    • Itraconazole
    • Voriconazole
    • Carbamazepine

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): NCT00089050

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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
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Principal Investigator: Stephen H. Petersdorf, MD Fred Hutchinson Cancer Research Center

Layout table for additonal information Identifier: NCT00089050    
Other Study ID Numbers: 1820.00
CDR0000378021 ( Registry Identifier: PDQ )
First Posted: August 5, 2004    Key Record Dates
Last Update Posted: November 30, 2011
Last Verified: November 2011
Keywords provided by Fred Hutchinson Cancer Research Center:
recurrent adult acute myeloid leukemia
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)
adult acute basophilic leukemia
adult acute eosinophilic leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antineoplastic Agents, Immunological
Antineoplastic Agents