A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: OCV-501; Drug: Placebo

• Registration Number: NCT01961882
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-14
• Primary Completion: 2017-11-16
• Study Completion: 2017-11-16
• Results First Submitted: 2021-02-11
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Results First Posted: 2021-03-26
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCV-501 arm	OCV-501	-
Placebo arm	Placebo	-

Primary Outcome Measures

Name	Time	Method
Disease-Free Survival	2 years (treatment period)	Disease-free survival (DFS) was defined as the time from randomization until relapse or death from any cause, whichever came first, by the DFS-cutoff date.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2 years (treatment period)	Subjects were surveyed for survival by the date of cutoff. The cutoff date was set as the date after 728 days (2 years) from the day that the last subject started IMP administration.