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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102150
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

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
Adult T-cell Leukemia/Lymphoma Drug: Valemetostat Tosylate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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 : November 21, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2025


Arm Intervention/treatment
Experimental: DS-3201b Drug: Valemetostat Tosylate
Once a day, 200 mg, oral administration
Other Name: DS-3201b




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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

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): NCT04102150


Contacts
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Contact: Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111(M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp

Locations
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Japan
Nagoya City University Hospital Recruiting
Nagoya-shi, Aichi, Japan
Contact: See Central Contact         
National Hospital Organization Kyushu Cancer Center Recruiting
Fukuoka-shi, Fukuoka, Japan
Contact: See Central Contact         
Hokkaido University Hospital Recruiting
Sapporo-shi, Hokkaido, Japan
Contact: See Central Contact         
Imamura General Hospital Recruiting
Kagoshima-shi, Kagoshima, Japan
Contact: See Central Contact         
Kumamoto University Hospital Recruiting
Kumamoto-shi, Kumamoto, Japan
Contact: See Central Contact         
Okayama University Hospital Recruiting
Okayama-shi, Okayama, Japan
Contact: See Central Contact         
University of the Ryukyus Hospital Recruiting
Nakagami-gun, Okinawa, Japan
Contact: See Central Contact         
Kindai University Hospital Recruiting
Osakasayama-shi, Osaka, Japan
Contact: See Central Contact         
Saitama Medical University International Medical Center Recruiting
Hidaka-shi, Saitama, Japan
Contact: See Central Contact         
National Cancer Center Hospital Recruiting
Chuo Ku, Tokyo, Japan
Contact: See Central Contact         
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo Recruiting
Minato-Ku, Tokyo, Japan
Contact: See Central Contact         
Kagoshima University Hospital Recruiting
Kagoshima-city, Japan
Contact: See Central Contact         
Nagasaki University Hospital Recruiting
Nagasaki-shi, Japan
Contact: See Central Contact         
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Clinical Study Leader Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT04102150    
Other Study ID Numbers: DS3201-A-J201
194964 ( Other Identifier: JAPIC CTI )
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
URL: http://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid