Clinical trial · Interventional
A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients
A Phase I Study of OCV-501 in the Treatment of Patients With Acute Myeloid Leukemia
NCT01440920CI-TRIAL-00050525completedPhase 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, tolerability of OCV-501 in patients with acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who completed a standard consolidation therapy.
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 (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 0.3 mg
- interventionNames
- Drug: OCV-501
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- 1 mg
- interventionNames
- Drug: OCV-501
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- 3 mg
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Key Inclusion Criteria: * Patients with acute myeloid leukemia including patients with secondary leukemia. However, the patients with MDS apparently evolved itno AML and patients with AML accompanied by t(15;17)(q22;q12),(PML/RARalpha) , should be excluded. * Patients who achieved the first complete remission after the induction regimen and finished a standard consolidation therapy. * Age: ≥ 60years of age(at the time of signature of the informed consent form) * Sex: Male and Female * Patients who are capable of giving informed consent * Patient's blasts cells show expression of WT1mRNA, detected by quantitative RT-PCR. * Patients must be one of the following HLA DRB1 types: HLA-DRB1\*01:01, \*04:05, \*15:01, \*15:02, \*08:03 and \*09:01. Key Exclusion Criteria: * Patients who are scheduled for a bone marrow transplantation * Patients who were administered exceeded acceptable therapeutic dose of immunosuppressants and adrenal cortical steroids. * Patients with uncontrollable active infectious diseases * Patients with autoimmune diseases (including Hashimoto's disease, idiopathic thrombocytopenic purpura, and autoimmune hepatitis) or with a medical history of active autoimmune diseases * Immunocompetent patients * Patients with a complication of interstitial pneumonia or with a medical history of interstitial pneumonia
References
Publications (0)
Data not yet available
No reference posted for this study.