Acute Myeloid Leukemia in RemissionPhase 2NCT04747002
Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "Dainippon Sumitomo Phama(DSP)-7888" for Acute Myeloid Leukemia Patients.
A Phase 2 study testing DSP-7888 in people with Acute Myeloid Leukemia in Remission, run by Osaka University at 1 site in Japan.
Trial summary
This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological complete remission (CR). DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize Wilms Tumor Gene 1 (WT1) peptides. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Acute Myeloid Leukemia in Remission
- What is being tested?
- DSP-7888
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 12 Jun 2020to Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification
- favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification
- 1st hematological after chemotherapy
- Human Leukocyte Antigen (HLA)-A*02:01, 02:06, 24:02
- 20-80 years old
- Eastern Cooperative Oncology Group (ECOG) performance Status 0-2
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- within 35 days after White Blood Cell (WBC) and Neutrophil recovers over 1500 and 500, respectively
- sufficient organ function as below within 7 days
- Neutrophil : >= 1000 (2) Cr : >= 3.0mg/dl (3) Aspartate aminotransferase (AST), Alanine transaminase (ALT) : 5 x the upper limit of normal (ULN) for the reference lab (4) Percutaneous oxygen saturation (SpO2): >= 95% 9) patients who agree contraception until 6 months after the last injection 10) non-candidate for hematopoietic stem cell transplantation.
- illegible for hematopoietic stem cell transplantation (HSCT)
- lack of appropriate donor
- patients who don't select HSCT at the 1st hematological complete remission (hCR) timing
Who cannot join
- multiple primary cancer
- autoimmune disease
- usage of investigational or unapproved drug within 28 days
- severe organ failure
- Human Immunodeficiency Virus (HIV) antibody / Hepatitis B surface (HBs) antigen / Hepatitis C Virus (HCV) antibody positive
- pregnant woman
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- lactating woman
- under treatment against active infection
- difficult to enroll because of mental problem
- other reasons which investigator judge appropriate for enrollment
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Osaka University
Suita, Osaka, 565-0871
Jun Nakata, +81668793676, mogura@sahs.med.osaka-u.ac.jp
About this study
Official title: Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "DSP-7888" for Acute Myeloid Leukemia Patients.
This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological complete remission (CR). DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize Wilms Tumor Gene 1 (WT1) peptides.
Read the detailed description
This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological CR. DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides. Primary endpoint is relapse-free survival, and 2nd endpoint is hematological relapse-free survival, overall survival and adverse event.
- Conditions
- Acute Myeloid Leukemia in Remission
- Being tested
- DSP-7888
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP-7888Drug
Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides
| Study group | Role | What they receive |
|---|---|---|
| Administration Group | Active comparator | Patients who are injected with DSP-7888. Receives: Drug: DSP-7888 |
| Non-administration Group | No intervention | Patients who are only under observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
Measured: 2 year
Secondary outcomes (3)
Hematological relapse-free survival
Measured: 2 year
Overall survival
Measured: 2 year
Adverse event
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start12 Jun 2020
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia in RemissionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development
- Responsible party
- Principal investigator, Yoichi Yamamoto, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747002
- Sponsor's protocol ID
- WT1-AM-05
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "DSP-7888" for Acute Myeloid Leukemia Patients.
- ClinicalTrials.gov ID
- NCT04747002
- Acronym / sponsor ID
- WT1-AM-05
- Conditions
- Acute Myeloid Leukemia in Remission
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological complete remission (CR). DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize Wilms Tumor Gene 1 (WT1) peptides.
Detailed description
This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological CR. DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides. Primary endpoint is relapse-free survival, and 2nd endpoint is hematological relapse-free survival, overall survival and adverse event.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration Group | Active comparator | Drug: DSP-7888Patients who are injected with DSP-7888. |
| Non-administration Group | No intervention | –Patients who are only under observation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification
- favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification
- 1st hematological after chemotherapy
- Human Leukocyte Antigen (HLA)-A*02:01, 02:06, 24:02
- 20-80 years old
Key exclusion criteria (10 listed)
- multiple primary cancer
- autoimmune disease
- usage of investigational or unapproved drug within 28 days
- severe organ failure
- Human Immunodeficiency Virus (HIV) antibody / Hepatitis B surface (HBs) antigen / Hepatitis C Virus (HCV) antibody positive
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 |
|---|---|---|
| DSP-7888Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides | Drug | Administration Group |
Primary outcome
Relapse-free survival
Time frame: 2 year
3 secondary outcomes
Hematological relapse-free survival
Time frame: 2 year
Overall survival
Time frame: 2 year
Adverse event
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DSP-7888 in people with Acute Myeloid Leukemia in Remission, run by Osaka University 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 12 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Nakata, M.D., Ph.D. (+81668793676, mogura@sahs.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (time frame: 2 year). 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 3 Mar 2021.