ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02436252
Previous Study | Return to List | Next Study

Study of DSP-7888 in Patients With Myelodysplastic Syndrome (MDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02436252
Recruitment Status : Active, not recruiting
First Posted : May 6, 2015
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: DSP-7888 Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of DSP-7888 in Patients With Myelodysplastic Syndrome (MDS)
Study Start Date : May 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DSP-7888 Drug: DSP-7888
3.5-10.5 mg/body,Id every 2-4 weeks




Primary Outcome Measures :
  1. Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT) [ Time Frame: 12 months ]
    Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT)

  2. Overall Survival (OS) [ Time Frame: 24 months ]
    Participants follow-up for overall survival will occur. Maximum follow-up time is 2 year after the initial administration of the last subject.


Secondary Outcome Measures :
  1. Overall Response Rate(ORR) [ Time Frame: 6 months ]
    HR(Hematologic Response), HI(Hematologic improvement) and Cytogenetic response assessed by IWG MDS response criteria 2006

  2. TI (Blood transfusion independence) [ Time Frame: 6 months ]
    Defined as the absence of any RBC or PLT transfusion for any consecutive 8 weeks

  3. Time to transformation to AML [ Time Frame: 24 months ]
    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.

  4. Biomarkers [ Time Frame: 6 months ]
    Explore efficacy related biomarkers assessed by delayed-type hypersensitivity (DTH) reactions to WT1 peptide and WT1 peptide-specific CTL-induction activity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

[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
  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436252


Locations
Japan
Japanese Red Cross Narita Hospital
Narita, Chiba, Japan
Chugoku Central Hospital
Fukuyama, Hiroshima, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa, Japan
Kochi Medical School Hospital
Nankoku, Kochi, Japan
Sendai Medical Center
Sendai, Miyagi, Japan
Kurashiki Central Hospital
Kurashiki, Okayama, Japan
Kindai University Hospital
Osakasayama, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Tokyo Metropolitan Geriatric Hospital
Itabashi-ku, Tokyo, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, Tokyo, Japan
Kyushu University Hospital
Fukuoka, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, Japan
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
Investigators
Study Director: Sumitomo Dainippon Pharma Co., Ltd. Japan Sumitomo Dainippon Pharma Co., Ltd.

Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT02436252     History of Changes
Other Study ID Numbers: DB650027
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Keywords provided by Sumitomo Dainippon Pharma Co., Ltd.:
Myelodysplastic Syndrome
MDS

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms