Phase I Study of gemtuzumab ozogamicin in combination with cytarabinne and idarubicin as induction therapy for relapsed or refractory patients with acute myeloid leukemia.

UMIN ID: UMIN000001142

Registered date:10/05/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Acute Myeloid Leukemia
• Date of first enrollment: 2006/10/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Combination chemotherapy of gemtuzumab ozogamicin+idarubicin+cytarabine as induction

Outcome(s)

• Primary Outcome: Dose limiting toxicity(DLT) ,maximum tolerated dose(MTD) and optimal dose and schedule of INR and GO
• Secondary Outcome: Rates of complete remission and safety profile and grades.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. History of MDS or MPD 2. Secondary AML related to chemotherapy or radiotherapy 3. CNS-leukemia 4. History of hematopoietic stem cell transplantation 5. Pregnant and/or lactating woman 6. History of therapy with anti-CD33 monoclonal antibody 7. Complication of active malignant diease 8. Uncontrolled infection 9.Positive HBV, HCV and HIV infection 10.History of attending any phase study of new drugs. 11.If physicians disagree to attend this study

Related Information

• Primary Sponsor: Japan Adult Leukemia Study Group
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare