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Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/Lymphoma

Sponsor
Daiichi Sankyo Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04102150
Collaborator
(none)
25
Enrollment
24
Locations
1
Arm
73.3
Anticipated Duration (Months)
1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase 2 study will be conducted to assess the efficacy and safety of valemetostat tosylate (DS-3201b) in participants with relapsed or refractory adult T-cell leukemia/lymphoma (r/r ATL).

Condition or Disease Intervention/Treatment Phase
  • Drug: Valemetostat Tosylate
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Open-label, Single-arm Study of Valemetostat Tosylate (DS-3201b) in Patients With Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
Actual Study Start Date :
Nov 21, 2019
Actual Primary Completion Date :
Apr 24, 2021
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: DS-3201b

Drug: Valemetostat Tosylate
Once a day, 200 mg, oral administration
Other Names:
  • DS-3201b

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate (ORR) assessed by central evaluation organization [Through the end of the study (within approximately 5 years)]

      The percentage of participants who were assessed for best overall response, who achieved complete remission (CR), complete remission, unconfirmed (CRu) or partial remission (PR) by central evaluation organization.

    Secondary Outcome Measures

    1. Overall response rate (ORR) assessed by investigator [Through the end of the study (within approximately 5 years)]

      The percentage of participants who were assessed for best overall response, who achieved CR, CRu, or PR by investigator.

    2. Best response per tumor lesions [Through the end of the study (within approximately 5 years)]

      Best response in target lesions (nodal or extranodal lesions), peripheral blood lesions, and skin lesions.

    3. Complete remission rate (CR rate) [Through the end of the study (within approximately 5 years)]

      The percentage of participants who were assessed for best overall response, who achieved CR or CRu.

    4. Tumor control rate (TCR) [Through the end of the study (within approximately 5 years)]

      The percentage of participants who were assessed for best overall response, who achieved CR, CRu, PR or stable disease (SD).

    5. Time to response (TTR) [Through the end of the study (within approximately 5 years)]

      Period from the first day of DS-3201b dose to the first day of CR, CRu, or PR

    6. Duration of response (DOR) [Through the end of the study (within approximately 5 years)]

      Period from first CR, CRu, or PR to residual disease/progressive disease (RD/PD) or death.

    7. Progression-free survival (PFS) [Through the end of the study (within approximately 5 years)]

      Period from the first day of DS-3201b dose to the day of RD/PD or death.

    8. Overall survival (OS) [Through the end of the study (within approximately 5 years)]

      Period from the first day of DS-3201b dose to death.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants with relapsed or refractory adult T-cell leukemia/lymphoma (ATL) who have history of treatment with mogamulizumab or are mogamulizumab intolerant, contraindication after treatment with at least 1 medication regimen

    • Aged ≥20 years or older at the time of signing the informed consent

    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2

    • At least 1 evaluable lesion

    • Participants who have defined laboratory criteria

    • Life expectancy ≥ 3 months

    Exclusion Criteria:

    • A presence of central nervous system involvement at the time of screening tests

    • Have poorly controlled complication (eg. chronic congestive heart failure, unstable angina

    • ≥ Grade 3 neuropathy

    • QT interval corrected using Fridericia's method (QTcF) >470 ms

    • Has an uncontrolled infection

    • Participants who use corticosteroids over 10 mg/day

    • Receipt of allogeneic hematopoietic stem cell transplantation

    • History of, or concurrent, malignant tumors

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nagoya City University Hospital Nagoya-shi Aichi Japan
    2 National Cancer Center Hospital East Kashiwa-shi Chiba Japan
    3 Ehime University Hospital Tōon-shi Ehime Japan
    4 Kyushu University Hospital Fukuoka-shi Fukuoka Japan
    5 National Hospital Organization Kyushu Cancer Center Fukuoka-shi Fukuoka Japan
    6 Hokkaido University Hospital Sapporo-shi Hokkaido Japan
    7 Imamura General Hospital Kagoshima-shi Kagoshima Japan
    8 Kochi Medical School Hospital Nankoku-shi Kochi Japan
    9 Kumamoto University Hospital Kumamoto-shi Kumamoto Japan
    10 National University Corporation Tohoku University Tohoku University Hospital Sendai-shi Miyagi Japan
    11 University of Miyazaki Hospital Miyazaki-shi Miyazaki Japan
    12 Local Incorporated Administrative Agency Sasebo City General Hospital Sasebo-shi Nagasaki Japan
    13 Okayama University Hospital Okayama-shi Okayama Japan
    14 University of the Ryukyus Hospital Nakagami-gun Okinawa Japan
    15 Osaka International Cancer Institute Osaka-shi Osaka Japan
    16 Kindai University Hospital Osakasayama-shi Osaka Japan
    17 Osaka University Hospital Suita-shi Osaka Japan
    18 Saga University Hospital Saga-shi Saga Japan
    19 Saitama Medical University International Medical Center Hidaka-shi Saitama Japan
    20 Hamamatsu University Hospital Hamamatsu-shi Shizuoka Japan
    21 National Cancer Center Hospital Chuo Ku Tokyo Japan
    22 IMSUT Hospital, The Institute of Medical Science, The University of Tokyo Minato-Ku Tokyo Japan
    23 Kagoshima University Hospital Kagoshima-city Japan
    24 Nagasaki University Hospital Nagasaki-shi Japan

    Sponsors and Collaborators

    • Daiichi Sankyo Co., Ltd.

    Investigators

    • Study Director: Clinical Study Leader, Daiichi Sankyo, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daiichi Sankyo Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04102150
    Other Study ID Numbers:
    • DS3201-A-J201
    • 194964
    First Posted:
    Sep 25, 2019
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Leukemia
    Leukemia, T-Cell
    Leukemia-Lymphoma, Adult T-Cell

    Study Results

    No Results Posted as of Jan 12, 2022