Unique ID issued by UMIN | UMIN000001142 |
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Receipt number | R000001386 |
Scientific Title | Phase I Study of gemtuzumab ozogamicin in combination with cytarabinne and idarubicin as induction therapy for relapsed or refractory patients with acute myeloid leukemia. |
Date of disclosure of the study information | 2008/05/10 |
Last modified on | 2011/10/31 16:03:29 |
Phase I Study of gemtuzumab ozogamicin in combination with cytarabinne and idarubicin as induction therapy for relapsed or refractory patients with acute myeloid leukemia.
Phase I Study of GO+Ara-C+IDR for Relapsed or Refractory Patients with Acute Myeloid Leukemia
Phase I Study of gemtuzumab ozogamicin in combination with cytarabinne and idarubicin as induction therapy for relapsed or refractory patients with acute myeloid leukemia.
Phase I Study of GO+Ara-C+IDR for Relapsed or Refractory Patients with Acute Myeloid Leukemia
Japan |
Acute Myeloid Leukemia
Hematology and clinical oncology |
Malignancy
NO
Investigation of safety and recommended schedule of combination chemotherapy with GO and conventional antiluekemic drugs.
Safety,Efficacy
Phase I
Dose limiting toxicity(DLT) ,maximum tolerated dose(MTD) and optimal dose and schedule of INR and GO
Rates of complete remission and safety profile and grades.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Combination chemotherapy of gemtuzumab ozogamicin+idarubicin+cytarabine as induction
20 | years-old | <= |
65 | years-old | > |
Male and Female
1.CD33-positive AML with first relapsed (CR duration>6 months) or refractory to initial induction therapy (exclusion of APL)
2.Age; above 20 to younger than 65 years old
3.PS 0-2 (ECOG)
4.More than 30 days after previous therapy
5. Adequate hepatic, renal, pulmonary and cardiac function
serum bilirubin <1.5 mg/dL, serum creatinine<2.0 mg/dL,PaO2>60 mmHg or SaO2>93%, ECG: WNL
6.More than 2 months of life expectancy
7. Written informed consent
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
18
1st name | |
Middle name | |
Last name | Noriko Usui |
The Jikei University School of Medicine(Dai-San Hospital)
Department of Clinical Oncology and Hematology
4-11-1,Izumi-honcho,Komae-shi,Tokyo
03-3480-1151
1st name | |
Middle name | |
Last name | Noriko Usui |
The Jikei University School of Medicine(Dai-San Hospital)
Department of Clinical Oncology and Hematology
4-11-1,Izumi-honcho,Komae-shi,Tokyo
03-3480-1151
http://www.jalsg.jp/
usuin@jikei.ac.jp
Japan Adult Leukemia Study Group
Ministry of Health, Labor and Welfare
NO
2008 | Year | 05 | Month | 10 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/21585619
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.
Completed
2006 | Year | 10 | Month | 05 | Day |
2006 | Year | 10 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2011 | Year | 02 | Month | 01 | Day |
2008 | Year | 04 | Month | 30 | Day |
2011 | Year | 10 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001386
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