Phase 1
Completed N=9
Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
Source: ClinicalTrials.gov NCT01475370 ↗Enrolled (actual)
9
Serious AEs
88.9%
Results posted
Mar 2021
Primary outcomePrimary: Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria — 2; 2; 2 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria |
2; 2; 2 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01475370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.