Clinical trial NCT04102150: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult T-cell Leukemia/Lymphoma
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Overall response rate (ORR) assessed by central evaluation organization
timeFrame: Through the end of the study (within approximately 5 years)
Secondary outcomes:
measure: Overall response rate (ORR) assessed by investigator
timeFrame: Through the end of the study (within approximately 5 years)
measure: Best response per tumor lesions
timeFrame: Through the end of the study (within approximately 5 years)
measure: Complete remission rate (CR rate)
timeFrame: Through the end of the study (within approximately 5 years)
measure: Tumor control rate (TCR)
timeFrame: Through the end of the study (within approximately 5 years)
measure: Time to response (TTR)
timeFrame: Through the end of the study (within approximately 5 years)
measure: Duration of response (DOR)
timeFrame: Through the end of the study (within approximately 5 years)
measure: Progression-free survival (PFS)
timeFrame: Through the end of the study (within approximately 5 years)
measure: Overall survival (OS)
timeFrame: Through the end of the study (within approximately 5 years)
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Tōon-shi
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kagoshima-shi
country: Japan
facility: Imamura General Hospital
state: Kagoshima
city: Nankoku-shi
country: Japan
facility: Kochi Medical School Hospital
state: Kochi
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto
city: Sendai-shi
country: Japan
facility: National University Corporation Tohoku University Tohoku University Hospital
state: Miyagi
city: Miyazaki-shi
country: Japan
facility: University of Miyazaki Hospital
state: Miyazaki
city: Sasebo-shi
country: Japan
facility: Local Incorporated Administrative Agency Sasebo City General Hospital
state: Nagasaki
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital
state: Okinawa
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Saga-shi
country: Japan
facility: Saga University Hospital
state: Saga
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Minato-Ku
country: Japan
facility: IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
state: Tokyo
city: Kagoshima-city
country: Japan
facility: Kagoshima University Hospital
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Study Leader
role: STUDY_DIRECTOR
References:
citation: 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.