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NCT Number: NCT04102150

Valemetostat Tosylate (DS-3201b) Phase 2 Study in 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).

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Key information

Conditions

Adult T-Cell Leukemia/Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nagoya City University Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valemetostat Tosylate

Drug

Once a day, 200 mg, oral administration

Other names: DS-3201b

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2024
First posted
Sep 25, 2019
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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