This trial is active, not recruiting.

Condition acute myeloid leukemia
Treatments ocv-501, placebo
Phase phase 2
Sponsor Otsuka Pharmaceutical Co., Ltd.
Collaborator Korea Otsuka Pharmaceutical Co., Ltd.
Start date October 2013
End date December 2017
Trial identifier NCT01961882, 311-12-001, JapicCTI-142429


To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment
(Placebo Comparator)

Primary Outcomes

Disease-Free Survival
time frame: 2 years

Secondary Outcomes

Overall Survival
time frame: 2 years

Eligibility Criteria

All participants at least 60 years old.

Inclusion Criteria: - Patients with AML who achieved first complete remission within one or two courses of standard induction therapy, and completed standard consolidation therapy (more than one course). - Patients who are 60 years or older. - 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. Exclusion 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, 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.

Additional Information

Official title A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd..