Phase 1 Completed N=9 Treatment

A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients

Acute Myeloid Leukemia

Source: ClinicalTrials.gov NCT01440920 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcomePrimary: Occurrence of Dose Limiting Toxicities — 0; 0; 0 participants

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.

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	—

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

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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. Informational only — not medical advice.