Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)

• Sponsor: Otsuka Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01475370
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Actual Duration (Months): 58.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: OCV-501	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Jan 24, 2012
• Actual Primary Completion Date: Dec 22, 2016
• Actual Study Completion Date: Dec 22, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OCV-501	Drug: OCV-501; Before the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the dose in the study 311-10-001. After the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the recommended dose.

Outcome Measures

Primary Outcome Measures

1. Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria [Treatment period (from the first IMP administration until the time of discontinuation)]

   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 Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center	Tokyo		Japan

Sponsors and Collaborators

• Otsuka Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01475370
• Other Study ID Numbers: 311-10-002; JapicCTI-111646
• First Posted: Nov 21, 2011
• Last Update Posted: Mar 2, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Otsuka Pharmaceutical Co., Ltd.: Acute myeloid leukemia; WT1
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

Participant Flow

Recruitment Details	This trial was an extension trial from the preceding Trial 311-10-001. Subjects who had undergone the observations, examinations, and evaluations which were stipulated for Trial 311-10-001 and who met all the inclusion criteria and did not fall under any of the exclusion criteria for this trial were selected for this trial.

Arm/Group Title	OCV-501 0.3mg	OCV-501 1 mg	OCV-501 3 mg
Arm/Group Description	OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).	OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).	OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
Period Title: Overall Study
STARTED	3	3	3
COMPLETED	0	0	0
NOT COMPLETED	3	3	3

Baseline Characteristics

Arm/Group Title	OCV-501 0.3mg	OCV-501 1 mg	OCV-501 3 mg	Total
Arm/Group Description	OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).	OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).	OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).	Total of all reporting groups
Overall Participants	3	3	3	9
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	1 33.3%	0 0%	1 33.3%	2 22.2%
>=65 years	2 66.7%	3 100%	2 66.7%	7 77.8%
Sex: Female, Male (Count of Participants)
Female	2 66.7%	2 66.7%	0 0%	4 44.4%
Male	1 33.3%	1 33.3%	3 100%	5 55.6%
Race/Ethnicity, Customized (Count of Participants)
Japanese	3 100%	3 100%	3 100%	9 100%
Region of Enrollment (Count of Participants)
Japan	3 100%	3 100%	3 100%	9 100%

Outcome Measures

1. Primary Outcome

Title	Incidence of Relapse of Acute Myeloid Leukemia Based on the International Working Group Response Criteria
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).
Time Frame	Treatment period (from the first IMP administration until the time of discontinuation)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OCV-501 0.3mg	OCV-501 1 mg	OCV-501 3 mg
Arm/Group Description	OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).	OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).	OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
Measure Participants	3	3	3
Number [participants]	2 66.7%	2 66.7%	2 66.7%

Adverse Events

Time Frame	Treatment-emergent adverse events were collected from the first IMP administration until the time of discontinuation.
Arm/Group Title	OCV-501 0.3mg		OCV-501 1 mg		OCV-501 3 mg
Arm/Group Description	OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 0.3 mg).		OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 1 mg).		OCV-501 was subcutaneously administered once a week, with each subject receiving the same dose as in Trial 311-10-001 (i.e. continued administration of 3 mg).
All Cause Mortality
	OCV-501 0.3mg		OCV-501 1 mg		OCV-501 3 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)		0/3 (0%)
Serious Adverse Events
	OCV-501 0.3mg		OCV-501 1 mg		OCV-501 3 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		2/3 (66.7%)		3/3 (100%)
Musculoskeletal and connective tissue disorders
Spinal column stenosis	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	2/3 (66.7%)		2/3 (66.7%)		1/3 (33.3%)
Pancreatic carcinoma	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Acute myeloid leukaemia recurrent	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Other (Not Including Serious) Adverse Events
	OCV-501 0.3mg		OCV-501 1 mg		OCV-501 3 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/3 (66.7%)		3/3 (100%)		3/3 (100%)
Congenital, familial and genetic disorders
Ichthyosis	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Ear and labyrinth disorders
Ear pruritus	1/3 (33.3%)		1/3 (33.3%)		0/3 (0%)
Vertigo positional	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Eye disorders
Conjunctival haemorrhage	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Dry eye	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Glaucoma	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Hypermetropia	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Gastrointestinal disorders
Dental caries	1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)
General disorders
Injection site reaction	2/3 (66.7%)		2/3 (66.7%)		3/3 (100%)
Injection site induration	1/3 (33.3%)		2/3 (66.7%)		0/3 (0%)
Injection site erythema	0/3 (0%)		2/3 (66.7%)		0/3 (0%)
Injection site discolouration	1/3 (33.3%)		1/3 (33.3%)		0/3 (0%)
Administration site reaction	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Injection site anaesthesia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Injection site mass	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Injection site pain	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Injection site pruritus	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Injection site swelling	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Hepatobiliary disorders
Liver disorder	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Immune system disorders
Drug hypersensitivity	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Infections and infestations
Nasopharyngitis	1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)
Upper respiratory tract infection	0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)
Abscess	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Cystitis	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Gastroenteritis	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Herpes zoster	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Localised infection	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Pharyngitis	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Subcutaneous abscess	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Oral herpes	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Injury, poisoning and procedural complications
Fall	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Head injury	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Contusion	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Procedural pain	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Investigations
Lymphocyte count decreased	0/3 (0%)		1/3 (33.3%)		2/3 (66.7%)
White blood cell count decreased	0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)
Alanine aminotransferase increased	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Aspartate aminotransferase increased	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
C-reactive protein increased	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Neutrophil count decreased	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Metabolism and nutrition disorders
Glucose tolerance impaired	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Hyperkalaemia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)
Arthralgia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Myalgia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Joint range of motion decreased	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Nervous system disorders
Headache	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Post herpetic neuralgia	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Sciatica	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Skin and subcutaneous tissue disorders
Eczema	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Eczema nummular	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Pruritus	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Rash	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Rash pruritic	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Vascular disorders
Hypertension	0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.