UMIN ID: UMIN000001141
Registered date:10/05/2008
Phase I Study of gemtuzumab ozogamicin in combination with cytarabinne and daunorubicin as induction therapy for relapsed or refractory patients with acute myeloid leukemia.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Acute Myeloid Leukemia |
| Date of first enrollment | 2006/11/01 |
| Target sample size | 24 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Combination chemotherapy of Gemtuzumab ozogamicin+Daunorubicin+Cytarabine as induction therapy |
Outcome(s)
| Primary Outcome | Dose limiting toxicity(DLT) ,maximum tolerated dose(MTD) and optimal dose and schedule of DNR 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 |
| Include criteria | |
| 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. Total dose of DNR >500 mg/m2 6. Pregnant and/or lactating woman 7. History of therapy with anti-CD33 monoclonal antibody 8. Complication of active malignant disease 9. Uncontrolled infection 10.Positive HBV, HCV and HIV infection 11.History of attending any phase study of new drugs. 12.If physisians disagree to attend this study |
Related Information
| Primary Sponsor | Japan Adult Leukemia Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labor and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Noriko Usui |
| Address | 4-11-1,Izumi-honcho,Komae-shi,Tokyo Japan |
| Telephone | 03-3480-1151 |
| usuin@jikei.ac.jp | |
| Affiliation | The Jikei University School of Medicine(Dai-San Hospital) Department of Clinical Oncology and Hematology |
| scientific contact | |
| Name | Noriko Usui |
| Address | 4-11-1,Izumi-honcho,Komae-shi,Tokyo Japan |
| Telephone | 03-3480-1151 |
| Affiliation | Department of Clinical Oncology and Hematology Department of Clinical Oncology and Hematology |