Adult T-cell Leukemia/LymphomaPhase 2NCT04102150
Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
A Phase 2 study testing Valemetostat Tosylate in people with Adult T-cell Leukemia/Lymphoma, run by Daiichi Sankyo Co., Ltd. at 24 sites in Japan.
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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Adult T-cell Leukemia/Lymphoma
- What is being tested?
- Valemetostat Tosylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 24 sitesJapan
- Study dates
- 21 Nov 2019to 27 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Japan24 sites
National Cancer Center Hospital
Chuo Ku, Tokyo
Kyushu University Hospital
Fukuoka, Fukuoka
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka
Hamamatsu University Hospital
Hamamatsu, Shizuoka
Saitama Medical University International Medical Center
Hidaka-shi, Saitama
Imamura General Hospital
Kagoshima, Kagoshima-ken
Kagoshima University Hospital
Kagoshima
National Cancer Center Hospital East
Kashiwa-shi, Chiba
Kumamoto University Hospital
Kumamoto, Kumamoto
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Minato-Ku, Tokyo
University of Miyazaki Hospital
Miyazaki, Miyazaki
Nagasaki University Hospital
Nagasaki
Nagoya City University Hospital
Nagoya, Aichi-ken
University of the Ryukyus Hospital
Nakagami-gun, Okinawa
Kochi Medical School Hospital
Nankoku-shi, Kochi
Okayama University Hospital
Okayama, Okayama-ken
Osaka International Cancer Institute
Osaka, Osaka
Kindai University Hospital
Osakasayama-shi, Osaka
Saga University Hospital
Saga, Saga-ken
Hokkaido University Hospital
Sapporo, Hokkaido
Local Incorporated Administrative Agency Sasebo City General Hospital
Sasebo-shi, Nagasaki
National University Corporation Tohoku University Tohoku University Hospital
Sendai, Miyagi
Osaka University Hospital
Suita-shi, Osaka
Ehime University Hospital
Tōon-shi, Ehime
About this study
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
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
- Being tested
- Valemetostat Tosylate
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valemetostat TosylateDrug
Also called DS-3201b
Once a day, 200 mg, oral administration
| Study group | Role | What they receive |
|---|---|---|
| DS-3201b | Experimental | Not described Receives: Drug: Valemetostat Tosylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through the end of the study (within approximately 5 years)
Secondary outcomes (8)
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.
Measured: Through the end of the study (within approximately 5 years)
Best response per tumor lesions
Best response in target lesions (nodal or extranodal lesions), peripheral blood lesions, and skin lesions.
Measured: Through the end of the study (within approximately 5 years)
Complete remission rate (CR rate)
The percentage of participants who were assessed for best overall response, who achieved CR or CRu.
Measured: Through the end of the study (within approximately 5 years)
Tumor control rate (TCR)
The percentage of participants who were assessed for best overall response, who achieved CR, CRu, PR or stable disease (SD).
Measured: Through the end of the study (within approximately 5 years)
Time to response (TTR)
Period from the first day of DS-3201b dose to the first day of CR, CRu, or PR
Measured: Through the end of the study (within approximately 5 years)
Duration of response (DOR)
Period from first CR, CRu, or PR to residual disease/progressive disease (RD/PD) or death.
Measured: Through the end of the study (within approximately 5 years)
Progression-free survival (PFS)
Period from the first day of DS-3201b dose to the day of RD/PD or death.
Measured: Through the end of the study (within approximately 5 years)
Overall survival (OS)
Period from the first day of DS-3201b dose to death.
Measured: Through the end of the study (within approximately 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start21 Nov 2019
- Primary completion24 Apr 2021
- Study completion27 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult T-cell Leukemia/LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102150
- Sponsor's protocol ID
- DS3201-A-J201
- Other IDs
- 194964
- Status last verified
- Feb 2025
- First submitted
- 23 Sep 2019
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Publications
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.
PubMed 36150143
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04102150
- Acronym / sponsor ID
- DS3201-A-J201
- Conditions
- Adult T-cell Leukemia/Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 24 Apr 2021 (actual)
- Study completion
- 27 Oct 2024 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DS-3201b | Experimental | Drug: Valemetostat Tosylate |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valemetostat TosylateAlso: DS-3201bOnce a day, 200 mg, oral administration | Drug | DS-3201b |
Primary outcome
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.
8 secondary outcomes
Overall response rate (ORR) assessed by investigator
Time frame: Through the end of the study (within approximately 5 years)
Best response per tumor lesions
Time frame: Through the end of the study (within approximately 5 years)
Complete remission rate (CR rate)
Time frame: Through the end of the study (within approximately 5 years)
Tumor control rate (TCR)
Time frame: Through the end of the study (within approximately 5 years)
Time to response (TTR)
Time frame: Through the end of the study (within approximately 5 years)
Duration of response (DOR)
Time frame: Through the end of the study (within approximately 5 years)
Progression-free survival (PFS)
Time frame: Through the end of the study (within approximately 5 years)
Overall survival (OS)
Time frame: Through the end of the study (within approximately 5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Derived from this study: PubMed 36150143Izutsu 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Leader study director
Daiichi Sankyo
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valemetostat Tosylate in people with Adult T-cell Leukemia/Lymphoma, run by Daiichi Sankyo Co., Ltd. at 24 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) assessed by central evaluation organization (time frame: Through the end of the study (within approximately 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04102150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.