A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia
- Conditions
- Elderly Patients With Acute Myeloid Leukemia
- Registration Number
- JPRN-jRCT2080222379
- Lead Sponsor
- Otsuka Pharmaceutical Co., LTD.
- Brief Summary
The result of a log-rank test showed no statistically significant difference in DFS and OS between the OCV-501 arm and the placebo arm. OCV-501 was generally safe and well tolerated in AML patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 134
Patients with AML who achieved first complete remission within one or two courses of standard
induction therapy, and completed standard consolidation therapy (one or more courses)
- Patients who have provided written informed consent within 90 days from the last dose of consolidation therapy on an informed consent form that has been approved by an institutional review board or independent ethics committee
(and other criteria)
- Patients who have acute promyelocytic leukemia (APL) with t(15;17)(q22;q12), (PML/RARA) karyotype abnormalities, and other variant types.
- Patients who are scheduled for hematopoietic stem cell transplantation
- Patients who have received drugs potentially affecting the immune system within 4 weeks before starting IMP administration or who may receive such drugs after start of the trial
- Patients who have a severe concurrent disease or psychiatric illness likely to interfere with participation in this trial
- Patients who are HIV antibody positive or HBV-DNA positive, or have unrecovered chronic hepatitis C with positive HCV antibody
- Patients who have cirrhosis
- Patients judged to be ineligible by the investigator (or subinvestigator) for any other reasons
(and other criteria)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method