Acute Myeloid LeukemiaPhase 1NCT01440920
A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients
A Phase 1 study testing OCV-501 in people with Acute Myeloid Leukemia, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- OCV-501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2011to Jul 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of OCV-501 in the Treatment of Patients With Acute Myeloid Leukemia
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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- OCV-501
- Keywords
- Acute myeloid leukemia, WT1
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCV-501Drug
subcutaneously administered once a week, 4 times at the dose of 0.3 mg
OCV-501Drug
subcutaneously administered once a week, 4 times at the dose of 1 mg
OCV-501Drug
subcutaneously administered once a week, 4 times at the dose of 3 mg
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 0.3 mg Receives: Drug: OCV-501 |
| Cohort 2 | Experimental | 1 mg Receives: Drug: OCV-501 |
| Cohort 3 | Experimental | 3 mg Receives: Drug: OCV-501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 Weeks
Secondary outcomes (1)
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440920
- Sponsor's protocol ID
- 311-10-001
- Other IDs
- JapicCTI-111623
- Status last verified
- Feb 2021
- First submitted
- 15 Sep 2011
- Last updated
- 8 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of OCV-501 in the Treatment of Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01440920
- Acronym / sponsor ID
- 311-10-001
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia, WT1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Posted 8 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: OCV-5010.3 mg |
| Cohort 2 | Experimental | Drug: OCV-5011 mg |
| Cohort 3 | Experimental | Drug: OCV-5013 mg |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCV-501subcutaneously administered once a week, 4 times at the dose of 0.3 mg | Drug | Cohort 1 |
| OCV-501subcutaneously administered once a week, 4 times at the dose of 1 mg | Drug | Cohort 2 |
| OCV-501subcutaneously administered once a week, 4 times at the dose of 3 mg | Drug | Cohort 3 |
Primary outcome
Occurrence of Dose Limiting Toxicities
Time frame: 4 Weeks
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.
1 secondary outcome
Recurrence Based on the Response Evaluation Criteria by the International Working Group
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OCV-501 in people with Acute Myeloid Leukemia, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Dose Limiting Toxicities (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.