acute myeloid leukemia
Conditions
Interventions
Dose of GO(div day4) is determined at each level in combination with BH-AC(200mg/m2, day1-8) + DNR 30mg/m2, day1-3.
Sponsors
Japan Adult Leukemia Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Firstly relapsed or primary refractory CD33-positive acute myeloid leukemia (excluding M3) 2) No history of GO treatment 3) ages, 65-74 4) PS, 0-1 5) AST, ALT < 2.5-fold of upper limit of each institute 6) Total bilillubin < 1.5 mg/dL 7) Serum creatinine < 2.0 mg/dL 8) No ischmic sign or arrythmia to be treated on ECG 9 Left ventricular ejection fraction > 50% 10) PaO2 > 65mmHg or SaO2 > 93% (room air) 11) Expected to survive more than two months 12) Written consent after careful information including insufficient experience in our country
Exclusion criteria
Exclusion criteria: 1) History of myelodysplastic syndromes or myeloproliferative neoplasms 2) Therapy-related leukemia 3) Infiltration on central nurvous system 4) Previous autologous or allogeneic stem cell transplantation 5) History of glaucoma 6) Diabetes mellitus currently treated with insulin 7) Uncontrollable hypertension 8) History of ischemic heart disease, cardiomyopathy or arrythmia currently treated 9) Interstitial pneumonia, pulmonary fibrosis, or svere emphysema 10) Positivity of HBs antigen, HCV antibody or human immunodeficiency virus 11) Active infectious disease 12) Liver cirrhosis 13) Double cancer 14) Difficulty of treatment based on mental illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimation of maximum tolerated dose | — |
Countries
Japan
Outcome results
None listed