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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

Tracking Information
First Submitted Date  ICMJE August 4, 2004
First Posted Date  ICMJE August 5, 2004
Last Update Posted Date November 30, 2011
Study Start Date  ICMJE May 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2007)
  • Efficacy in terms of complete remission rate
  • Toxicity
  • Pharmacokinetics
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00089050 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2007)
Correlate clinical response to laboratory studies of drug susceptibility
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia
Official Title  ICMJE A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia
Intervention  ICMJE
  • Drug: cyclosporine
  • Drug: gemtuzumab ozogamicin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE


  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00089050
Other Study ID Numbers  ICMJE 1820.00
CDR0000378021 ( Registry Identifier: PDQ )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Stephen H. Petersdorf, MD Fred Hutchinson Cancer Research Center
PRS Account Fred Hutchinson Cancer Research Center
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP