Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)

Otsuka

Status and phase: Completed; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: OCV-501

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475370

311-10-002

JapicCTI-111646 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the safety of OCV-501 in patients with AML who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study.

Enrollment: 18 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study.
• Patients who are capable of giving informed consent

Exclusion criteria

• Patients failed to discontinue the Study 311-10-001 even though patients met the discontinuation criteria.
• Patients who have participated in any other clinical trials , excluding the Study 311-10-001).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

OCV-501

Experimental group

Treatment:

Drug: OCV-501