Trial Outcomes & Findings for A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients (NCT NCT01440920)

Last Updated: 2021-03-08

Results Overview

Dose limiting toxicity (DLT) was defined as any of the following adverse events occurring by Day 29 (7 days after the last investigational medicinal product \[IMP\] administration) of this trial for which a causal relationship to the IMP could not be ruled out. Severity of the adverse events was evaluated in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) ver. 4.0. Blood toxicity did not include hematology parameters of laboratory tests. * Non-blood toxicities ≥ Grade 3, excluding cases of anorexia, nausea, vomiting, diarrhea, and constipation where it is possible to continue the clinical trial by use of supportive therapy * Blood toxicities ≥ Grade 4, although febrile neutropenia ≥ Grade 3 will be counted as DLT.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

4 Weeks

Results posted on

2021-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 subcutaneously administered once a week, 4 times at the dose of 0.3 mg	Cohort 2 subcutaneously administered once a week, 4 times at the dose of 1 mg	Cohort 3 subcutaneously administered once a week, 4 times at the dose of 3 mg
Overall Study STARTED	3	3	3
Overall Study COMPLETED	3	3	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=3 Participants subcutaneously administered once a week, 4 times at the dose of 0.3 mg	Cohort 2 n=3 Participants subcutaneously administered once a week, 4 times at the dose of 1 mg	Cohort 3 n=3 Participants subcutaneously administered once a week, 4 times at the dose of 3 mg	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	3 Participants n=107 Participants	2 Participants n=206 Participants	7 Participants n=7 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	4 Participants n=7 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants
Race/Ethnicity, Customized Japanese	3 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	9 Participants n=7 Participants
Region of Enrollment Japan	3 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	9 Participants n=7 Participants

PRIMARY outcome

Timeframe: 4 Weeks

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants subcutaneously administered once a week, 4 times at the dose of 0.3 mg	Cohort 2 n=3 Participants subcutaneously administered once a week, 4 times at the dose of 1 mg	Cohort 3 n=3 Participants subcutaneously administered once a week, 4 times at the dose of 3 mg
Occurrence of Dose Limiting Toxicities	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 4 weeks

A case will be designated as relapse if any of the following occur. Reappearance of leukemic blast cells in the peripheral blood or ≥5% blast cells in the bone marrow after complete remission (morphologic relapse).

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants subcutaneously administered once a week, 4 times at the dose of 0.3 mg	Cohort 2 n=3 Participants subcutaneously administered once a week, 4 times at the dose of 1 mg	Cohort 3 n=3 Participants subcutaneously administered once a week, 4 times at the dose of 3 mg
Recurrence Based on the Response Evaluation Criteria by the International Working Group	0 participants	0 participants	0 participants

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 3

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Director of Clinical Trials

Otsuka Pharmaceutical Co., LTD.

Phone: +81-3-6361-7366

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1 n=3 participants at risk subcutaneously administered once a week, 4 times at the dose of 0.3 mg	Cohort 2 n=3 participants at risk subcutaneously administered once a week, 4 times at the dose of 1 mg	Cohort 3 n=3 participants at risk subcutaneously administered once a week, 4 times at the dose of 3 mg
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Eye disorders Cataract	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Eye disorders Vitreous floaters	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Gastrointestinal disorders Stomatitis	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
General disorders Injection site erythema	100.0% 3/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	100.0% 3/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	100.0% 3/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
General disorders Injection site induration	66.7% 2/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	66.7% 2/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	100.0% 3/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
General disorders Injection site mass	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
General disorders Injection site pain	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
General disorders Injection site pruritus	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	66.7% 2/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Investigations Eosinophil count increased	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Investigations Lymphocyte count decreased	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Investigations Neutrophil count decreased	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Investigations Platelet count decreased	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Investigations White blood cell count decreased	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Investigations Protein urine present	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Metabolism and nutrition disorders Hyperlipidaemia	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Musculoskeletal and connective tissue disorders Joint swelling	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Nervous system disorders Dizziness	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Nervous system disorders Headache	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Nervous system disorders Hypoaesthesia	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).
Skin and subcutaneous tissue disorders Erythema	33.3% 1/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).	0.00% 0/3 • Treatment-emergent adverse events were collected from start of the first IMP administration (Day 1) to Post-treatment observation (Day 50).