Clinical Trials /

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

NCT04102150

Description:

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).

Related Conditions:
  • Adult T-Cell Leukemia/Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: DS3201-A-J201
  • SECONDARY ID: 194964
  • NCT ID: NCT04102150

Conditions

  • Adult T-cell Leukemia/Lymphoma

Interventions

DrugSynonymsArms
Valemetostat TosylateDS-3201bDS-3201b

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
DS-3201bExperimental
  • Valemetostat Tosylate

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure:Overall response rate (ORR) assessed by investigator
Time Frame:Through the end of the study (within approximately 5 years)
Safety Issue:
Description:The percentage of participants who were assessed for best overall response, who achieved CR, CRu, or PR by investigator.
Measure:Best response per tumor lesions
Time Frame:Through the end of the study (within approximately 5 years)
Safety Issue:
Description:Best response in target lesions (nodal or extranodal lesions), peripheral blood lesions, and skin lesions.
Measure:Complete remission rate (CR rate)
Time Frame:Through the end of the study (within approximately 5 years)
Safety Issue:
Description:The percentage of participants who were assessed for best overall response, who achieved CR or CRu.
Measure:Tumor control rate (TCR)
Time Frame:Through the end of the study (within approximately 5 years)
Safety Issue:
Description:The percentage of participants who were assessed for best overall response, who achieved CR, CRu, PR or stable disease (SD).
Measure:Time to response (TTR)
Time Frame:Through the end of the study (within approximately 5 years)
Safety Issue:
Description:Period from the first day of DS-3201b dose to the first day of CR, CRu, or PR
Measure:Duration of response (DOR)
Time Frame:Through the end of the study (within approximately 5 years)
Safety Issue:
Description:Period from first CR, CRu, or PR to residual disease/progressive disease (RD/PD) or death.
Measure:Progression-free survival (PFS)
Time Frame:Through the end of the study (within approximately 5 years)
Safety Issue:
Description:Period from the first day of DS-3201b dose to the day of RD/PD or death.
Measure:Overall survival (OS)
Time Frame:Through the end of the study (within approximately 5 years)
Safety Issue:
Description:Period from the first day of DS-3201b dose to death.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Daiichi Sankyo Co., Ltd.

Last Updated

March 26, 2020