Clinical trial · Interventional
Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
NCT01475370CI-TRIAL-00050403completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OCV-501 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OCV-501
- interventionNames
- Drug: OCV-501
Primary outcomes (1)
- measure
- Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria
- timeFrame
- Treatment period (from the first IMP administration until the time of discontinuation)
- description
- Bone marrow samples were taken by bone marrow aspiration, and the percentage of bone marrow blasts was calculated. The result was assessed according to the International Working Group Response Evaluation Criteria where a case was designated as relapse if any of the following occurred: reappearance of leukemic blasts in the peripheral blood or ≥ 5% blasts in the bone marrow after complete response (morphologic relapse).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.