Phase I Study of gemtuzumab ozogamicin in combination with cytarabinne and idarubicin as induction therapy for relapsed or refractory patients with acute myeloid leukemia.
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- JPRN-UMIN000001142
- Lead Sponsor
- Japan Adult Leukemia Study Group
- Brief Summary
Among 19 patients (nine in the IAG regimen, 10 in the DAG regimen), the median age was 59 years (range 33-64), and the relapsed/refractory ratio was 13/6. In the therapy using 3 mg/m(2) GO in the IAG or DAG regimen, grade 3/4 leukopenia and neutropenia were observed in all patients, but none had grade 3/4 non-hematological toxicities, except febrile neutropenia. Three patients in the IAG regimen who were administered 5 mg/m(2) GO showed DLT. No patients had veno-occlusive disease or sinusoidal obstructive syndrome. In conclusion, 3 mg/m(2) GO combined with Ara-C and IDR or DNR can be safely administered, and phase II trials should be conducted to investigate the clinical efficacy of the combination therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose limiting toxicity(DLT) ,maximum tolerated dose(MTD) and optimal dose and schedule of INR and GO
- Secondary Outcome Measures
Name Time Method Rates of complete remission and safety profile and grades.