NCT04102150CompletedPhase 2
Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
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
Source: ClinicalTrials.gov · Last updated 10 Feb 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 23 Sept 2019
- Start date
- 21 Nov 2019
- Primary completion date
- 24 Apr 2021
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT04102150
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 25
- From 21 Nov 2019 to the primary completion date, 24 Apr 2021
- 24 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who use corticosteroids over 10 mg/day
- Receipt of allogeneic hematopoietic stem cell transplantation
- History of, or concurrent, malignant tumors
Other illness
- Have poorly controlled complication (eg. chronic congestive heart failure, unstable angina
- Has an uncontrolled infection
Lab values
- QT interval corrected using Fridericia's method (QTcF) \>470 ms
Other
- A presence of central nervous system involvement at the time of screening tests
- ≥ Grade 3 neuropathy
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| National Hospital Organization Kyushu Cancer Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Hamamatsu University Hospital Coordinator of this site? Confirm its status | Hamamatsu | Japan | Unknown status |
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Hidaka-shi | Japan | Unknown status |
| Imamura General Hospital Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Kagoshima University Hospital Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Kumamoto University Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| IMSUT Hospital, The Institute of Medical Science, The University of Tokyo Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| University of Miyazaki Hospital Coordinator of this site? Confirm its status | Miyazaki | Japan | Unknown status |
| Nagasaki University Hospital Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| University of the Ryukyus Hospital Coordinator of this site? Confirm its status | Nakagami Gun | Japan | Unknown status |
| Kochi Medical School Hospital Coordinator of this site? Confirm its status | Nankoku-shi | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Kindai University Hospital Coordinator of this site? Confirm its status | Osakasayama-Shi | Japan | Unknown status |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Local Incorporated Administrative Agency Sasebo City General Hospital Coordinator of this site? Confirm its status | Sasebo-shi | Japan | Unknown status |
| National University Corporation Tohoku University, Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Osaka University Hospital Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Ehime University Hospital Coordinator of this site? Confirm its status | Toon-shi | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.