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

February 15, 2024 updated by: Daiichi Sankyo Co., Ltd.

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kagoshima-city, Japan
        • Kagoshima University Hospital
      • Nagasaki-shi, Japan
        • Nagasaki University Hospital
    • Aichi
      • Nagoya-shi, Aichi, Japan
        • Nagoya City University Hospital
    • Chiba
      • Kashiwa-shi, Chiba, Japan
        • National Cancer Center Hospital East
    • Ehime
      • Tōon-shi, Ehime, Japan
        • Ehime University Hospital
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
        • Kyushu University Hospital
      • Fukuoka-shi, Fukuoka, Japan
        • National Hospital Organization Kyushu Cancer Center
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan
        • Hokkaido University Hospital
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan
        • Imamura General Hospital
    • Kochi
      • Nankoku-shi, Kochi, Japan
        • Kochi Medical School Hospital
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan
        • Kumamoto University Hospital
    • Miyagi
      • Sendai-shi, Miyagi, Japan
        • National University Corporation Tohoku University Tohoku University Hospital
    • Miyazaki
      • Miyazaki-shi, Miyazaki, Japan
        • University of Miyazaki Hospital
    • Nagasaki
      • Sasebo-shi, Nagasaki, Japan
        • Local Incorporated Administrative Agency Sasebo City General Hospital
    • Okayama
      • Okayama-shi, Okayama, Japan
        • Okayama University Hospital
    • Okinawa
      • Nakagami-gun, Okinawa, Japan
        • University of the Ryukyus Hospital
    • Osaka
      • Osaka-shi, Osaka, Japan
        • Osaka International Cancer Institute
      • Osakasayama-shi, Osaka, Japan
        • Kindai University Hospital
      • Suita-shi, Osaka, Japan
        • Osaka University Hospital
    • Saga
      • Saga-shi, Saga, Japan
        • Saga University Hospital
    • Saitama
      • Hidaka-shi, Saitama, Japan
        • Saitama Medical University International Medical Center
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan
        • Hamamatsu University Hospital
    • Tokyo
      • Chuo Ku, Tokyo, Japan
        • National Cancer Center Hospital
      • Minato-Ku, Tokyo, Japan
        • IMSUT Hospital, The Institute of Medical Science, The University of Tokyo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DS-3201b
Drug: Valemetostat Tosylate
Once a day, 200 mg, oral administration
Other Names:
  • DS-3201b

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) assessed by central evaluation organization
Time Frame: 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.
Through the end of the study (within approximately 5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) assessed by investigator
Time Frame: 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.
Through the end of the study (within approximately 5 years)
Best response per tumor lesions
Time Frame: 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.
Through the end of the study (within approximately 5 years)
Complete remission rate (CR rate)
Time Frame: 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.
Through the end of the study (within approximately 5 years)
Tumor control rate (TCR)
Time Frame: 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).
Through the end of the study (within approximately 5 years)
Time to response (TTR)
Time Frame: 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
Through the end of the study (within approximately 5 years)
Duration of response (DOR)
Time Frame: 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.
Through the end of the study (within approximately 5 years)
Progression-free survival (PFS)
Time Frame: 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.
Through the end of the study (within approximately 5 years)
Overall survival (OS)
Time Frame: Through the end of the study (within approximately 5 years)
Period from the first day of DS-3201b dose to death.
Through the end of the study (within approximately 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo Co., Ltd.

Investigators

  • Study Director: Clinical Study Leader, Daiichi Sankyo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2019

Primary Completion (Actual)

April 24, 2021

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS3201-A-J201
  • 194964 (Other Identifier: JAPIC CTI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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