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

Primary Purpose

Adult T-cell Leukemia/Lymphoma

Status
Active
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Valemetostat Tosylate
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult T-cell Leukemia/Lymphoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nagoya City University Hospital
  • National Cancer Center Hospital East
  • Ehime University Hospital
  • Kyushu University Hospital
  • National Hospital Organization Kyushu Cancer Center
  • Hokkaido University Hospital
  • Imamura General Hospital
  • Kochi Medical School Hospital
  • Kumamoto University Hospital
  • National University Corporation Tohoku University Tohoku University Hospital
  • University of Miyazaki Hospital
  • Local Incorporated Administrative Agency Sasebo City General Hospital
  • Okayama University Hospital
  • University of the Ryukyus Hospital
  • Osaka International Cancer Institute
  • Kindai University Hospital
  • Osaka University Hospital
  • Saga University Hospital
  • Saitama Medical University International Medical Center
  • Hamamatsu University Hospital
  • National Cancer Center Hospital
  • IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
  • Kagoshima University Hospital
  • Nagasaki University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DS-3201b

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate (ORR) assessed by central evaluation organization
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

Overall response rate (ORR) assessed by investigator
The percentage of participants who were assessed for best overall response, who achieved CR, CRu, or PR by investigator.
Best response per tumor lesions
Best response in target lesions (nodal or extranodal lesions), peripheral blood lesions, and skin lesions.
Complete remission rate (CR rate)
The percentage of participants who were assessed for best overall response, who achieved CR or CRu.
Tumor control rate (TCR)
The percentage of participants who were assessed for best overall response, who achieved CR, CRu, PR or stable disease (SD).
Time to response (TTR)
Period from the first day of DS-3201b dose to the first day of CR, CRu, or PR
Duration of response (DOR)
Period from first CR, CRu, or PR to residual disease/progressive disease (RD/PD) or death.
Progression-free survival (PFS)
Period from the first day of DS-3201b dose to the day of RD/PD or death.
Overall survival (OS)
Period from the first day of DS-3201b dose to death.

Full Information

First Posted
September 23, 2019
Last Updated
February 1, 2023
Sponsor
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04102150
Brief Title
Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 21, 2019 (Actual)
Primary Completion Date
April 24, 2021 (Actual)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult T-cell Leukemia/Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DS-3201b
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Valemetostat Tosylate
Other Intervention Name(s)
DS-3201b
Intervention Description
Once a day, 200 mg, oral administration
Primary Outcome Measure Information:
Title
Overall response rate (ORR) assessed by central evaluation organization
Description
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.
Time Frame
Through the end of the study (within approximately 5 years)
Secondary Outcome Measure Information:
Title
Overall response rate (ORR) assessed by investigator
Description
The percentage of participants who were assessed for best overall response, who achieved CR, CRu, or PR by investigator.
Time Frame
Through the end of the study (within approximately 5 years)
Title
Best response per tumor lesions
Description
Best response in target lesions (nodal or extranodal lesions), peripheral blood lesions, and skin lesions.
Time Frame
Through the end of the study (within approximately 5 years)
Title
Complete remission rate (CR rate)
Description
The percentage of participants who were assessed for best overall response, who achieved CR or CRu.
Time Frame
Through the end of the study (within approximately 5 years)
Title
Tumor control rate (TCR)
Description
The percentage of participants who were assessed for best overall response, who achieved CR, CRu, PR or stable disease (SD).
Time Frame
Through the end of the study (within approximately 5 years)
Title
Time to response (TTR)
Description
Period from the first day of DS-3201b dose to the first day of CR, CRu, or PR
Time Frame
Through the end of the study (within approximately 5 years)
Title
Duration of response (DOR)
Description
Period from first CR, CRu, or PR to residual disease/progressive disease (RD/PD) or death.
Time Frame
Through the end of the study (within approximately 5 years)
Title
Progression-free survival (PFS)
Description
Period from the first day of DS-3201b dose to the day of RD/PD or death.
Time Frame
Through the end of the study (within approximately 5 years)
Title
Overall survival (OS)
Description
Period from the first day of DS-3201b dose to death.
Time Frame
Through the end of the study (within approximately 5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya City University Hospital
City
Nagoya-shi
State/Province
Aichi
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba
Country
Japan
Facility Name
Ehime University Hospital
City
Tōon-shi
State/Province
Ehime
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Imamura General Hospital
City
Kagoshima-shi
State/Province
Kagoshima
Country
Japan
Facility Name
Kochi Medical School Hospital
City
Nankoku-shi
State/Province
Kochi
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
Facility Name
National University Corporation Tohoku University Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi
Country
Japan
Facility Name
University of Miyazaki Hospital
City
Miyazaki-shi
State/Province
Miyazaki
Country
Japan
Facility Name
Local Incorporated Administrative Agency Sasebo City General Hospital
City
Sasebo-shi
State/Province
Nagasaki
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-shi
State/Province
Okayama
Country
Japan
Facility Name
University of the Ryukyus Hospital
City
Nakagami-gun
State/Province
Okinawa
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama-shi
State/Province
Osaka
Country
Japan
Facility Name
Osaka University Hospital
City
Suita-shi
State/Province
Osaka
Country
Japan
Facility Name
Saga University Hospital
City
Saga-shi
State/Province
Saga
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka-shi
State/Province
Saitama
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu-shi
State/Province
Shizuoka
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo Ku
State/Province
Tokyo
Country
Japan
Facility Name
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
City
Minato-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima-city
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
36150143
Citation
Izutsu K, Makita S, Nosaka K, Yoshimitsu M, Utsunomiya A, Kusumoto S, Morishima S, Tsukasaki K, Kawamata T, Ono T, Rai S, Katsuya H, Ishikawa J, Yamada H, Kato K, Tachibana M, Kakurai Y, Adachi N, Tobinai K, Yonekura K, Ishitsuka K. An open-label, single-arm phase 2 trial of valemetostat for relapsed or refractory adult T-cell leukemia/lymphoma. Blood. 2023 Mar 9;141(10):1159-1168. doi: 10.1182/blood.2022016862.
Results Reference
derived

Learn more about this trial

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

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