A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
OCV-501, Acute Myeloid Leukemia, Antigen specific cancer immunotherapeutic
Study Type
Interventional
Study Phase
Phase 2
Study Design
Primary Purpose: Treatment
Intervention
Name: OCV-501 Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 60 Years
Gender: Both
Criteria: 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.
Locations
Chubu Region, Japan
Status: Recruiting
Chugoku Region, Japan
Status: Recruiting
Hokkaido Region, Japan
Status: Recruiting
Kanto Region, Japan
Status: Recruiting
Kinki Region, Japan
Status: Recruiting
Kyushu Region, Japan
Status: Recruiting
Shikoku Region, Japan
Status: Recruiting
Tohoku Region, Japan
Status: Recruiting
Daegu, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Kaoshiung, Taiwan
Status: Recruiting
Taichung, Taiwan
Status: Recruiting
Tainan, Taiwan
Status: Recruiting
Taipei, Taiwan
Status: Recruiting
Start Date
October 2013
Completion Date
December 2017
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Source
Otsuka Pharmaceutical Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page