Acute Myeloid LeukemiaPhase 2NCT01961882

A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia

A Phase 2 study testing OCV-501 in people with Acute Myeloid Leukemia, run by Otsuka Pharmaceutical Co., Ltd. at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo. 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 134 participants
Where: 14 sitesin 3 countries
Study dates: Oct 2013to 16 Nov 2017
Phase: Phase 2
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 AML who achieved first complete remission within one or two courses of standard induction therapy, and completed standard consolidation therapy (more than one course).
Patients who are 60 years or older.
Patients who have provided written informed consent within 90 days from the last dose of consolidation therapy on an informed consent form that has been approved by an institutional review board or independent ethics committee.

Who cannot join

Patients who have acute promyelocytic leukemia (APL) with t(15;17) (q22;q12), (PML/RARA) karyotype abnormalities, and other variant types.
Patients who are scheduled for hematopoietic stem cell transplantation.
Patients who have received drugs potentially affecting the immune system within 4 weeks before starting IMP administration or who may receive such drugs after start of the trial.
Patients who have a severe concurrent disease or psychiatric illness likely to interfere with participation in this trial.
Patients who are HIV antibody positive, HBV-DNA positive or have unrecovered chronic hepatitis C with positive HCV antibody.
Patients who have cirrhosis.
Patients judged to be ineligible by the investigator (or subinvestigator) for any other reasons.

Trial locations and contacts

14 sites in 3 countries.

Country

City, postcode or hospital

14 sites in 3 countries

Japan8 sites

Study site
Chubu Region
Study site
Chugoku Region
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Kyushu Region
Study site
Shikoku Region
Study site
Tohoku Region

Other trials in Japan

Taiwan4 sites

Study site
Kaoshiung
Study site
Taichung
Study site
Tainan
Study site
Taipei

Other trials in Taiwan

South Korea2 sites

Study site
Daegu
Study site
Seoul

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia

To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.

Conditions: Acute Myeloid Leukemia
Being tested: OCV-501, Placebo
Keywords: OCV-501, Acute Myeloid Leukemia, Antigen specific cancer immunotherapeutic
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
PlaceboDrug

Study groups in NCT01961882
Study group	Role	What they receive
OCV-501 arm	Experimental	Not described Receives: Drug: OCV-501
Placebo arm	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease-Free Survival
Disease-free survival (DFS) was defined as the time from randomization until relapse or death from any cause, whichever came first, by the DFS-cutoff date.
Measured: 2 years (treatment period)

Secondary outcomes (1)

Overall Survival
Subjects were surveyed for survival by the date of cutoff. The cutoff date was set as the date after 728 days (2 years) from the day that the last subject started IMP administration.
Measured: 2 years (treatment period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201316 Nov 2017

First posted14 Oct 2013 (estimated)
Study startOct 2013
Primary completion16 Nov 2017
Study completion16 Nov 2017

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01961882
Sponsor's protocol ID: 311-12-001
Other IDs: JapicCTI-142429
Status last verified: Mar 2021
First submitted: 10 Oct 2013
Last updated: 26 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT01961882
Acronym / sponsor ID: 311-12-001
Conditions: Acute Myeloid Leukemia
Keywords: OCV-501, Acute Myeloid Leukemia, Antigen specific cancer immunotherapeutic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Korea Otsuka Pharmaceutical Co., Ltd.
Study start: Oct 2013
Primary completion: 16 Nov 2017 (actual)
Study completion: 16 Nov 2017 (actual)
First posted: 14 Oct 2013 (estimated)
Results: Posted 26 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
OCV-501 arm	Experimental	Drug: OCV-501
Placebo arm	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with AML who achieved first complete remission within one or two courses of standard induction therapy, and completed standard consolidation therapy (more than one course).
Patients who are 60 years or older.
Patients who have provided written informed consent within 90 days from the last dose of consolidation therapy on an informed consent form that has been approved by an institutional review board or independent ethics committee.

Key exclusion criteria (7 listed)

Patients who have acute promyelocytic leukemia (APL) with t(15;17) (q22;q12), (PML/RARA) karyotype abnormalities, and other variant types.
Patients who are scheduled for hematopoietic stem cell transplantation.
Patients who have received drugs potentially affecting the immune system within 4 weeks before starting IMP administration or who may receive such drugs after start of the trial.
Patients who have a severe concurrent disease or psychiatric illness likely to interfere with participation in this trial.
Patients who are HIV antibody positive, HBV-DNA positive or have unrecovered chronic hepatitis C with positive HCV antibody.

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-501	Drug	OCV-501 arm
Placebo	Drug	Placebo arm

Primary outcome

Disease-Free Survival
Time frame: 2 years (treatment period)
Disease-free survival (DFS) was defined as the time from randomization until relapse or death from any cause, whichever came first, by the DFS-cutoff date.

1 secondary outcome

Overall Survival
Time frame: 2 years (treatment period)

Results and safety

Results posted to the registry on 26 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OCV-501	69	19
Placebo	65	23

Primary outcome: Disease-Free Survival

Time frame: 2 years (treatment period). Number (95% Confidence Interval). Unit: percentage of participants

Measure	OCV-501 n = 68	Placebo n = 65
Value	40.9 (28.2 to 53.2)	41.4 (28.9 to 53.5)

Population analysed: FAS: all subjects who received the IMP at least once and from whom data on at least 1 efficacy endpoint were obtained after the start of IMP administration.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events were collected from the first dose of IMP to post-treatment observation (up to 17 days after the last dose of IMP or within 7 days from withdrawal judgment).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OCV-501	7 of 68 (10.3%)	67 of 68 (98.5%)	1 of 68
Placebo	7 of 65 (10.8%)	59 of 65 (90.8%)	1 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 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.

Jun-ichi Hashimoto, PhD study director

Otsuka Pharmaceutical Co., Ltd.

14 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OCV-501 in people with Acute Myeloid Leukemia, run by Otsuka Pharmaceutical Co., Ltd. at 14 sites in 3 countries.

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 3 inclusion and 7 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 26 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 14 sites in Japan, Taiwan, South Korea. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 26 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?

Disease-Free Survival (time frame: 2 years (treatment period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01961882.

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 26 Mar 2021.