Back to resultsA Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
OCV-501
OCV-501
OCV-501
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute myeloid leukemia, WT1
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
Sites / Locations
- National Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
0.3 mg
1 mg
3 mg
Outcomes
Primary Outcome Measures
Occurrence of Dose Limiting Toxicities
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.
Secondary Outcome Measures
Recurrence Based on the Response Evaluation Criteria by the International Working Group
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).
Full Information
NCT ID
NCT01440920
First Posted
September 15, 2011
Last Updated
February 15, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01440920
Brief Title
A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients
Official Title
A Phase I Study of OCV-501 in the Treatment of Patients With Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute myeloid leukemia, WT1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
0.3 mg
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
1 mg
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
3 mg
Intervention Type
Drug
Intervention Name(s)
OCV-501
Intervention Description
subcutaneously administered once a week, 4 times at the dose of 0.3 mg
Intervention Type
Drug
Intervention Name(s)
OCV-501
Intervention Description
subcutaneously administered once a week, 4 times at the dose of 1 mg
Intervention Type
Drug
Intervention Name(s)
OCV-501
Intervention Description
subcutaneously administered once a week, 4 times at the dose of 3 mg
Primary Outcome Measure Information:
Title
Occurrence of Dose Limiting Toxicities
Description
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.
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Recurrence Based on the Response Evaluation Criteria by the International Working Group
Description
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).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
National Cancer Center
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients
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