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Myelodysplastic SyndromePhase 1/2MDSNCT02436252

Study of DSP-7888 in Patients With Myelodysplastic Syndrome

A Phase 1/2 study testing DSP-7888 in people with Myelodysplastic Syndrome, run by Sumitomo Pharma Co., Ltd. at 16 sites in Japan.

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

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with MDS for whom no effective therapies currently exist. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Myelodysplastic Syndrome
What is being tested?
DSP-7888
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
16 sitesJapan
Study dates
May 2015to Mar 2020
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • [For Phase 1 part only]
  • Patients with a diagnosis of MDS according to either the fourth edition of the WHO classification or the FAB classification, with the exception of those with chronic myelomonocytic leukemia (CMML) or refractory anemia with excess blasts in transformation (RAEB-t)
  • Patients with an International Prognostic Scoring System (IPSS) score of ≧ 1.5 at enrollment, or patients with an IPSS score of < 1.5 who require additional treatment to supportive therapy in the opinion of the investigator or subinvestigator.
  • Patients who will be able to be hospitalized from the initial dose of DSP-7888 until the end of the post-initial dose observation (Patients may be permitted to have a temporary overnight leave during the hospitalization.)
  • [For Phase 2 part only]
  • Patients with a diagnosis of MDS according to either the fourth edition of the WHO classification or the FAB classification
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  • Patients with an IPSS score of ≧ 1.5 at enrollment, or patients with an IPSS score of < 1.5 with myeloblasts ≧ 5%
  • Patients who received at least one cycle of azacitidine therapy
  • [For both Phase 1 and 2 parts]
  • Patients with a peripheral white blood cell count of ≦12,000/mm3 within 4 weeks (28 days) before enrollment (on the basis of the most recent data during the period if multiple data are available)
  • Patients aged ≧20 years at the time of informed consent
  • Patients who have provided written voluntary consent in person to participate in this study after fully receiving and understanding the information about this study, including study objectives, contents, expected pharmacological actions and effects, and foreseeable risks
  • Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2 at enrollment
  • Patients with a life expectancy of ≧ 3 months (90 days)
  • Patients for whom no standard therapies are currently available, including transplant treatments such as allogeneic stem cell transplant
  • Patients with a human leukocyte antigen (HLA) type of HLA-A*24:02 or HLA-A*02:01/06
  • Patients with adequate major organ functions meeting the following criteria on the basis of laboratory data within 4 weeks (28 days) before enrollment (if multiple data are available, most recent data during the period)
  • Serum creatinine: ≦ 2-fold the upper limit of the normal range of the study site (ULN)
  • Total bilirubin: ≦2-fold the ULN
  • AST, ALT: ≦3-fold the ULN
  • Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use appropriate contraception from the time of consent until 6 months (180 days) after the last dose of the study drug to avoid pregnancy
  • Female patients of childbearing potential must have a negative pregnancy test (urine) within 4 weeks (28 days) before enrollment

Who cannot join

  • Patients with a dry tap on bone marrow aspiration before enrollment
  • Patients with grade ≧ 3 infection according to the Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE v4.0)
  • Patients with a positive test result for HIV antibody, HBs antigen or HCV antibody
  • Patients with any intracranial metastasis that is symptomatic or requires treatment
  • Patients with active multiple cancers (synchronous multiple cancers, or metachronous multiple cancers with a disease-free period of ≦ 5 years, with the exception of carcinoma in situ, mucosal carcinoma, or other such carcinomas curatively treated with local therapy)
  • Patients who had myocardial infarction within 6 months (180 days) before enrollment
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  • Patients with significant diseases at enrollment that may affect study treatment, such as New York Heart Association (NYHA) Functional Class III or IV heart disease, CTCAE v4.0 grade ≧ 3 arrhythmia, angina pectoris, abnormal electrocardiogram findings, interstitial pneumonia or pulmonary fibrosis
  • Patients with uncontrollable complications
  • Patients with CTCAE v4.0 grade ≧2 hemorrhage
  • Patients who underwent allogeneic hematopoietic stem cell transplant
  • Patients who received any of the following treatments within the specified period before enrollment:
  • Surgery, radiotherapy, chemotherapy (including molecular-targeted drugs): 4 weeks (28 days)
  • Immunosuppressants, cytokine preparations (excluding G-CSF): 4 weeks (28 days)
  • Endocrine therapy, immunotherapy (including biological response modifier therapy): 2 weeks (14 days)
  • Pregnant women or breastfeeding women
  • Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, or patients who require long-term systemic steroid therapy (excluding therapy given on a PRN basis)
  • Patients with any ongoing CTCAE v4.0 grade ≧ 2 adverse effects of prior treatment (excluding alopecia and phlebitis)
  • Patients who received any investigational product or post-marketing study drug within 4 weeks (28 days) before enrollment
  • Patients with a history of allergy to any oily drug products
  • Patients who previously received DSP-7888, any other WT1 peptide, or WT1 immunotherapy
  • Patients who are inappropriate for participation in the study for other reasons in the opinion of the investigator or subinvestigator

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Japan16 sites

  • Kyushu University Hospital

    Fukuoka

  • National Hospital Organization Kyushu Medical Center

    Fukuoka

  • Chugoku Central Hospital

    Fukuyama, Hiroshima

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken

  • Kochi Medical School Hospital

    Nankoku, Kochi

  • Japanese Red Cross Narita Hospital

    Narita, Chiba

  • Okayama City General Medical Center Okayama City Hospital

    Okayama

  • Kindai University Hospital

    Sayama, Osaka

  • Sendai Medical Center

    Sendai, Miyagi

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo

  • NTT Medical Center Tokyo

    Shinagawa-ku, Tokyo

  • Keio University Hospital

    Shinjuku-ku, Tokyo

  • Osaka University Hospital

    Suita, Osaka

  • Tokyo Metropolitan Geriatric Hospital

    tabashi City, Tokyo

  • National Hospital Organization Disaster Medical Center

    Tachikawa, Tokyo

  • Yokohama Municipal Citizen's Hospital

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: Phase 1/2 Study of DSP-7888 in Patients With Myelodysplastic Syndrome (MDS)

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with MDS for whom no effective therapies currently exist.

Read the detailed description

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with MDS for whom no effective therapies currently exist. In the Phase 1 part, high risk and low risk patients with MDS requiring additional treatment will be enrolled, and two different dose levels of DSP-7888 (3.5 and 10.5 mg/body) will be investigated in a stepwise manner starting with the lower dose using the 3+3 design, to determine the MTD and the RD for the Phase 2 part based on DLT evaluation during the 29 days following the initial dose of DSP-7888. In the Phase 2 part, DSP-7888 therapy at the RD determined by the Phase 1 part will be administered to high risk patients with MDS who had received and not responded to azacitidine as a standard treatment.

Being tested
DSP-7888
Keywords
Myelodysplastic Syndrome, MDS
Medical subject headings
Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DSP-7888Drug

    3.5-10.5 mg/body,Id every 2-4 weeks

Study groups in NCT02436252
Study groupRoleWhat they receive
DSP-7888ExperimentalNot described
Receives: Drug: DSP-7888

What is being measured

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

  1. Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT)

    Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT)

    Measured: 12 months

  2. Overall Survival （OS）

    Participants follow-up for overall survival will occur. Maximum follow-up time is 2 year after the initial administration of the last subject.

    Measured: 24 months

Secondary outcomes (4)

  1. Overall Response Rate（ORR）

    HR（Hematologic Response）, HI（Hematologic improvement） and Cytogenetic response assessed by IWG MDS response criteria 2006

    Measured: 6 months

  2. TI （Blood transfusion independence）

    Defined as the absence of any RBC or PLT transfusion for any consecutive 8 weeks

    Measured: 6 months

  3. Time to transformation to AML

    Participants follow-up for time to transformation to AML will occur. Maximum follow-up time is 2 year after the initial administration of the last subject.

    Measured: 24 months

  4. Biomarkers

    Explore efficacy related biomarkers assessed by delayed-type hypersensitivity (DTH) reactions to WT1 peptide and WT1 peptide-specific CTL-induction activity

    Measured: 6 months

Timeline

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

  1. First posted6 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionMar 2020
  4. Study completionMar 2020

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02436252
Sponsor's protocol ID
DB650027
Acronym
MDS
Status last verified
Apr 2022
First submitted
23 Apr 2015
Last updated
12 Apr 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DSP-7888 in people with Myelodysplastic Syndrome, run by Sumitomo Pharma Co., Ltd. at 16 sites 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 22 inclusion and 21 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 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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 combined 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.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02436252.

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 12 Apr 2022.

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