Phase 1
N=9
A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients
Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01440920 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Occurrence of Dose Limiting Toxicities — 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- OCV-501 (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Dose Limiting Toxicities |
0; 0; 0 | — |
| SECONDARY Recurrence Based on the Response Evaluation Criteria by the International Working Group |
0; 0; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01440920). 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.