Phase I study of Gemtuzumab Ozogamicin given in combination with Enocitabine and Daunorubicin as induction therapy for elderly patients with acute myeloid leukemia

Not Applicable

• Conditions: acute myeloid leukemia

• Registration Number: JPRN-UMIN000002603
• Lead Sponsor: Japan Adult Leukemia Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-13
• Study Completion: 2011-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified