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Last Modified: 8/15/2007     First Published: 9/1/2000  
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Phase II Study of Gemtuzumab Ozogamicin (CMA-676) and High-Dose Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Gemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed17 and overNCICALGB-19902
NCT00006265

Objectives

  1. Determine the response rate in patients with relapsed or refractory acute myeloid leukemia treated with gemtuzumab ozogamicin (CMA-676) and high-dose cytarabine.
  2. Determine the safety and toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

  • One of the following diagnoses:
    • Primary refractory acute myeloid leukemia (AML)
      • More than 10% blasts in the bone marrow or blood after recovery from 2 courses of standard cytarabine- and anthracycline-based induction chemotherapy
      • No prior remission
    • Relapsed AML
      • More than 10% blasts in the bone marrow or blood after documented remission
      • Prior remission lasted more than 30 days
      • No prior treatment for current relapse


  • CD33 expression on at least 20% of leukemia blast cells at initial diagnosis for primary refractory patients or at the time of relapse for all other patients


  • No active CNS involvement


Prior/Concurrent Therapy:

Biologic therapy:

  • At least 6 months since prior stem cell transplantation

Chemotherapy:

  • See Disease Characteristics
  • Prior etoposide and/or thioguanine during remission induction allowed
  • Prior hydroxyurea for control of AML allowed
  • At least 24 hours since prior hydroxyurea
  • At least 3 months since prior high-dose cytarabine (greater than 2 g/m2/dose)-containing regimen
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent steroids for adrenal failure, hypersensitivity reactions, or septic shock allowed
  • Concurrent ophthalmic corticosteroids allowed
  • Concurrent hormones for nondisease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic conditions) allowed

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • More than 2 months since prior cytotoxic therapy

Patient Characteristics:

Age:

  • 17 and over

Performance status:

  • 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics
  • WBC less than 30,000/mm3

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • No veno-occlusive disease of the liver
  • No chronic liver disease unless due to AML

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active serious infection

Expected Enrollment

A total of 36 patients will be accrued for phase I of the study and a total of 37 patients will be accrued for phase II of the study within 2 years. (Phase I closed to accrual effective 08/25/2003).

Outline

This is a dose-escalation study of gemtuzumab ozogamicin (CMA-676) (phase I closed to accrual effective 08/25/2003). Patients are stratified according to disease status (refractory vs relapsed).

  • Phase I (closed to accrual effective 08/25/2003): Patients are enrolled in one of four cohorts.
    • Cohort I (closed to accrual as of 10/1/02): Patients receive CMA-676 at the first dose level IV over 2 hours on days 1 and 8.


    • Cohort IA (open to accrual as of 10/15/02): Patients receive high-dose cytarabine (HD-ARA-C) IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7.


    • Cohort II: Patients receive HD-ARA-C as in cohort IA and CMA-676 at the first dose level IV over 2 hours on days 7 and 14.


    • Cohort IV: Patients receive CMA-676 at the second dose level and HD-ARA-C as in cohort II.


    Dose escalation stops if at least 3 of 9 patients experience dose-limiting toxicity.



  • Phase II: Patients receive HD-ARA-C IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7 (one course).


Patients are followed at 1 month, monthly for 6 months, every 3 months for 2 years, and then annually for 10 years.

Published Results

Stone RM, Moser B, Schulman P, et al.: A dose escalation and phase II study of gemtuzumab ozogamicin (GO) with high-dose cytarabine (HiDAC) for patients (pts) with refractory or relapsed acute myeloid leukemia (AML): CALGB 19902. [Abstract] Blood 104 (11): A-873, 2004.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Richard Stone, MD, Protocol chair
Ph: 617-632-2214; 866-790-4500
Email: rstone@partners.org

Registry Information
Official Title A Dose Escalation And Phase II Study Of Gemtuzumab Ozogamicin (CMA-676; Mylotarg) With High-Dose Cytarabine For Patients With Refractory Or Relapsed Acute Myeloid Leukemia (AML)
Trial Start Date 2001-03-20
Registered in ClinicalTrials.gov NCT00006265
Date Submitted to PDQ 2000-08-04
Information Last Verified 2004-04-26
NCI Grant/Contract Number U10-CA31946

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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