MedPath

S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia

Phase 2
Completed
Conditions
Leukemia
Registration Number
NCT00049179
Lead Sponsor
SWOG Cancer Research Network
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. Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells.

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

Detailed Description

OBJECTIVES:

* Determine the safety and efficacy of gemtuzumab ozogamicin and cytarabine in patients with relapsed acute myeloid leukemia.

* Determine the frequency and severity of toxic effects of this regimen in CD33-positive patients.

* Determine, preliminarily, the prognostic significance of drug resistance phenotype, cytogenetics, and molecular genetic characteristics of patients treated with this regimen.

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.

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
33
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
CRAfter induction therapy is completed
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (151)

Alta Bates Comprehensive Cancer Center

🇺🇸

Berkeley, California, United States

Mills-Peninsula Health Services

🇺🇸

Burlingame, California, United States

Marin Cancer Institute at Marin General Hospital

🇺🇸

Greenbrae, California, United States

Sutter Health Western Division Cancer Research Group

🇺🇸

Greenbrae, California, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

🇺🇸

Orange, California, United States

California Pacific Medical Center - California Campus

🇺🇸

San Francisco, California, United States

Phoebe Cancer Center at Phoebe Putney Memorial Hospital

🇺🇸

Albany, Georgia, United States

Piedmont Hospital

🇺🇸

Atlanta, Georgia, United States

CCOP - Atlanta Regional

🇺🇸

Atlanta, Georgia, United States

Northside Hospital Cancer Center

🇺🇸

Atlanta, Georgia, United States

Scroll for more (141 remaining)
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.