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

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	17 and over	NCI	CALGB-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.

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

Back to Top