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

Adult T-cell Leukemia/Lymphoma Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04102150
• Other study ID #: DS3201-A-J201
• Secondary ID: 194964
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 21, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Daiichi Sankyo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 31, 2025
• Est. primary completion date: April 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult T-cell Leukemia/Lymphoma
• Leukemia
• Leukemia, T-Cell
• Leukemia-Lymphoma, Adult T-Cell
• Lymphoma

Intervention

Drug:
• Valemetostat Tosylate
Once a day, 200 mg, oral administration

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo Ku	Tokyo
Japan	Kyushu University Hospital	Fukuoka-shi	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka-shi	Fukuoka
Japan	Hamamatsu University Hospital	Hamamatsu-shi	Shizuoka
Japan	Saitama Medical University International Medical Center	Hidaka-shi	Saitama
Japan	Kagoshima University Hospital	Kagoshima-city
Japan	Imamura General Hospital	Kagoshima-shi	Kagoshima
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
Japan	Kumamoto University Hospital	Kumamoto-shi	Kumamoto
Japan	IMSUT Hospital, The Institute of Medical Science, The University of Tokyo	Minato-Ku	Tokyo
Japan	University of Miyazaki Hospital	Miyazaki-shi	Miyazaki
Japan	Nagasaki University Hospital	Nagasaki-shi
Japan	Nagoya City University Hospital	Nagoya-shi	Aichi
Japan	University of the Ryukyus Hospital	Nakagami-gun	Okinawa
Japan	Kochi Medical School Hospital	Nankoku-shi	Kochi
Japan	Okayama University Hospital	Okayama-shi	Okayama
Japan	Osaka International Cancer Institute	Osaka-shi	Osaka
Japan	Kindai University Hospital	Osakasayama-shi	Osaka
Japan	Saga University Hospital	Saga-shi	Saga
Japan	Hokkaido University Hospital	Sapporo-shi	Hokkaido
Japan	Local Incorporated Administrative Agency Sasebo City General Hospital	Sasebo-shi	Nagasaki
Japan	National University Corporation Tohoku University Tohoku University Hospital	Sendai-shi	Miyagi
Japan	Osaka University Hospital	Suita-shi	Osaka
Japan	Ehime University Hospital	Toon-shi	Ehime

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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