Oblimersen and Gemtuzumab Ozogamicin 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: NCT00017589
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug.

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

Condition or disease Intervention/treatment Phase
Leukemia Biological: oblimersen sodium Drug: gemtuzumab ozogamicin Phase 2

Detailed Description:


  • Determine the complete response rate of elderly patients with relapsed CD33-positive acute myeloid leukemia treated with oblimersen and gemtuzumab ozogamicin.
  • Determine the overall response rate and duration of response of patients treated with this regimen.
  • Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oblimersen IV continuously on days 1-7 and 15-22 and gemtuzumab ozogamicin IV over 2 hours on days 4 and 18.

Patients are followed monthly for 6 months.

PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study within 1 year.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Study of Genasense (Bcl-2 Antisense) Combined With Mylotarg (Gemtuzumab Ozogamicin) in Elderly Patients With Relapsed Acute Myeloid Leukemia
Study Start Date : December 2000
Actual Study Completion Date : May 2006

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


  • Histologically confirmed CD33+ acute myeloid leukemia (AML)

    • In first relapse from chemotherapy
    • Complete response lasting at least 3 months before relapse
  • No CNS leukemia
  • No secondary leukemia or history of antecedent hematologic disorder prior to initial onset of AML (e.g., myelodysplasia)



  • 60 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • WBC less than 30,000/mm^3
  • No bleeding or coagulation disorder except disease-related disseminated intravascular coagulation


  • Bilirubin no greater than 1.5 mg/dL
  • PT and PTT no greater than 1.5 times upper limit of normal OR
  • INR no greater than 1.3
  • No history of chronic hepatitis or cirrhosis


  • Creatinine no greater than 2.0 mg/dL


  • No uncontrolled congestive heart failure
  • No New York Heart Association class III or IV heart disease


  • No severe pulmonary disease


  • HIV negative
  • No other concurrent medical disease that would preclude study entry
  • No known hypersensitivity to phosphorothioate-containing oligonucleotides, gemtuzumab ozogamicin or any of its components, E. coli protein, or any product produced in E. coli
  • No other concurrent malignancy
  • No known human anti-human antibodies
  • No uncontrolled seizure disorder
  • No active uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • No prior allogeneic or autologous stem cell transplantation
  • No prior therapy with an anti-CD33 antibody (e.g., gemtuzumab ozogamicin or M195)


  • See Disease Characteristics
  • At least 2 weeks since prior cancer chemotherapy except intrathecal chemotherapy or hydroxyurea

Endocrine therapy:

  • Not specified


  • At least 2 weeks since prior systemic radiotherapy


  • At least 2 weeks since prior major surgery
  • No prior organ allograft


  • At least 3 weeks since prior antileukemic therapy and recovered
  • No other concurrent investigational therapy
  • No concurrent immunosuppressive therapy

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): NCT00017589

United States, New Jersey
Genta Incorporated
Berkeley Heights, New Jersey, United States, 07922
Sponsors and Collaborators
Genta Incorporated
Study Chair: Stanley R. Frankel, MD Genta Incorporated

Publications of Results: Identifier: NCT00017589     History of Changes
Other Study ID Numbers: CDR0000068721
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: April 2003

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents