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

• ClinicalTrials.gov Identifier: NCT04102150
• Recruitment Status: Active, not recruiting
• First Posted: September 25, 2019
• Last Update Posted: February 16, 2024
• Sponsor: Daiichi Sankyo Co., Ltd.
• Information provided by (Responsible Party): Daiichi Sankyo ( Daiichi Sankyo Co., Ltd. )

Tracking Information

• First Submitted Date: September 23, 2019
• First Posted Date: September 25, 2019
• Last Update Posted Date: February 16, 2024
• Actual Study Start Date: November 21, 2019
• Actual Primary Completion Date: April 24, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 23, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 23, 2019)

• 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.
• 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.
• 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.
• 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).
• 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
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Adult T-cell Leukemia/Lymphoma

Intervention

Drug: Valemetostat Tosylate

Once a day, 200 mg, oral administration

Other Name: DS-3201b

Study Arms

Experimental: DS-3201b

Intervention: Drug: Valemetostat Tosylate

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 23, 2019): 25
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Actual Primary Completion Date: April 24, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT04102150
• Other Study ID Numbers: DS3201-A-J201; 194964 ( Other Identifier: JAPIC CTI )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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/

• Current Responsible Party: Daiichi Sankyo ( Daiichi Sankyo Co., Ltd. )
• Original Responsible Party: Same as current
• Current Study Sponsor: Daiichi Sankyo Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Study Leader; Daiichi Sankyo

• PRS Account: Daiichi Sankyo
• Verification Date: February 2024