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

NCT04102150 | Completed Phase 2

• 2 other identifiers: DS3201-A-J201194964
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 24

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).

Conditions

Adult T-cell Leukemia/Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Through the end of the study (within approximately 5 years)

Secondary Outcomes (8)

• Overall response rate (ORR) assessed by investigator

  Through the end of the study (within approximately 5 years)

• Best response per tumor lesions

  Through the end of the study (within approximately 5 years)

• Complete remission rate (CR rate)

  Through the end of the study (within approximately 5 years)

• Tumor control rate (TCR)

  Through the end of the study (within approximately 5 years)

• Time to response (TTR)

  Through the end of the study (within approximately 5 years)

Study Arms (1)

DS-3201b

EXPERIMENTAL

Drug: Valemetostat Tosylate

Interventions

Valemetostat Tosylate DRUG

Once a day, 200 mg, oral administration

Also known as: DS-3201b

DS-3201b

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (24)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Location

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Location

Ehime University Hospital

Tōon-shi, Ehime, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Location

Imamura General Hospital

Kagoshima, Kagoshima-ken, Japan

Location

Kochi Medical School Hospital

Nankoku-shi, Kochi, Japan

Location

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Location

National University Corporation Tohoku University Tohoku University Hospital

Sendai, Miyagi, Japan

Location

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Location

Local Incorporated Administrative Agency Sasebo City General Hospital

Sasebo-shi, Nagasaki, Japan

Location

Okayama University Hospital

Okayama, Okayama-ken, Japan

Location

University of the Ryukyus Hospital

Nakagami-gun, Okinawa, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, Japan

Location

Kindai University Hospital

Osakasayama-shi, Osaka, Japan

Location

Osaka University Hospital

Suita-shi, Osaka, Japan

Location

Saga University Hospital

Saga, Saga-ken, Japan

Location

Saitama Medical University International Medical Center

Hidaka-shi, Saitama, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Location

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Location

IMSUT Hospital, The Institute of Medical Science, The University of Tokyo

Minato-Ku, Tokyo, Japan

Location

Kagoshima University Hospital

Kagoshima, Japan

Location

Nagasaki University Hospital

Nagasaki, Japan

Location

Related Publications (1)

• 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.

  PMID: 36150143 DERIVED

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Study Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: November 21, 2019
• Primary Completion: April 24, 2021
• Study Completion: October 27, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

JP (24)