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

Alternate Title

Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI SWOG-S0117 S0117, NCT00049179

Objectives

1. Determine the safety and efficacy of gemtuzumab ozogamicin and cytarabine in patients with relapsed acute myeloid leukemia.
2. Determine the frequency and severity of toxic effects of this regimen in CD33-positive patients.
3. Determine, preliminarily, the prognostic significance of drug resistance phenotype, cytogenetics, and molecular genetic characteristics of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed acute myeloid leukemia (AML)
  • FAB M1-2 or M4-7
  • No blastic transformation of chronic myelogenous leukemia



• In first relapse after prior complete response
  • Patients who relapsed after autologous or allogeneic bone marrow or peripheral blood stem cell transplantation are not eligible



• CD33 positive



• Prior myelodysplastic syndromes or secondary AML allowed



• Concurrent enrollment on SWOG-9007 (cytogenetics protocol)



• No clinical or documented CNS involvement with AML

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• No prior gemtuzumab ozogamicin for AML

Chemotherapy

• Prior hydroxyurea to control high cell counts allowed

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 4 weeks since prior investigational agents and recovered

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC no greater than 30,000/mm³

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST or ALT no greater than 1.5 times ULN

Renal

• Not specified

Cardiovascular

• No unstable cardiac arrhythmias
• No unstable angina

Other

• HIV negative
• No other malignancy within the past 5 years except for the following:
  • Adequately treated basal cell or squamous cell skin cancer
  • Carcinoma in situ of the cervix
  • Adequately treated stage I or II cancer currently in complete remission
• Not pregnant or nursing
• Fertile patients must use effective contraception

Expected Enrollment

A total of 30-55 patients will be accrued for this study within 10-28 months.

Outcomes

Safety and efficacy
Toxicity
Prognostic significance of drug resistance phenotype, cytogenetics, and molecular genetic characteristics

Outline

This is a multicenter study.

• Induction: Patients receive gemtuzumab ozogamicin IV over at least 2 hours on days 1 and 8 and cytarabine IV continuously over days 1-7.



• Consolidation: Beginning between days 28 and 75, patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status receive one course of gemtuzumab ozogamicin and cisplatin as in induction chemotherapy.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

John Godwin, MD, MS, Protocol chair(Contact information may not be current)		Ph: 708-216-9000

Registry Information
Official Title		A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients with Relapsed Acute Myeloid Leukemia (AML)
Trial Start Date		2003-04-01
Registered in ClinicalTrials.gov		NCT00049179
Date Submitted to PDQ		2002-09-05
Information Last Verified		2005-10-11
NCI Grant/Contract Number		U10-CA32102

Back to Top