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NCT04102150
Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
Phase 2 trial testing Valemetostat Tosylate in Adult T-cell Leukemia/Lymphoma in 25 participants. Completed in 27 October 2024.
24 April 2021
Quick facts
| Lead sponsor | Daiichi Sankyo Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 21 November 2019 |
| Primary completion | 24 April 2021 |
| Estimated completion | 27 October 2024 |
| Sites | 24 locations across Japan |
Drugs / interventions tested
- Valemetostat Tosylate — full drug profile →
Conditions studied
- Adult T-cell Leukemia/Lymphoma — all drugs for Adult T-cell Leukemia/Lymphoma →
Sponsor
Daiichi Sankyo Co., Ltd. — full company profile →
Who can join
20 and older, any sex, with Adult T-cell Leukemia/Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
EZH2: a novel target for cancer treatment.
Duan R, Du W, Guo W. · · 2020 · cited 652× · PMID 32723346 · DOI 10.1186/s13045-020-00937-8 -
EZH2-Targeted Therapies in Cancer: Hype or a Reality.
Eich ML, Athar M, Ferguson JE, Varambally S. · · 2020 · cited 188× · PMID 32978169 · DOI 10.1158/0008-5472.can-20-2147 -
Epigenetics and beyond: targeting writers of protein lysine methylation to treat disease.
Bhat KP, Ümit Kaniskan H, Jin J, Gozani O. · · 2021 · cited 181× · PMID 33469207 · DOI 10.1038/s41573-020-00108-x -
An open-label, single-arm phase 2 trial of valemetostat for relapsed or refractory adult T-cell leukemia/lymphoma.
Izutsu K, Makita S, Nosaka K, Yoshimitsu M, et al · · 2023 · cited 118× · PMID 36150143 · DOI 10.1182/blood.2022016862 -
The roles of EZH2 in cancer and its inhibitors.
Liu Y, Yang Q. · · 2023 · cited 100× · PMID 37148376 · DOI 10.1007/s12032-023-02025-6 -
Mechanisms of action and resistance in histone methylation-targeted therapy.
Yamagishi M, Kuze Y, Kobayashi S, Nakashima M, et al · · 2024 · cited 95× · PMID 38383791 · DOI 10.1038/s41586-024-07103-x -
Methylation across the central dogma in health and diseases: new therapeutic strategies.
Liu R, Zhao E, Yu H, Yuan C, et al · · 2023 · cited 79× · PMID 37620312 · DOI 10.1038/s41392-023-01528-y -
New Insights Into the Role of Phenotypic Plasticity and EMT in Driving Cancer Progression.
Bhatia S, Wang P, Toh A, Thompson EW. · · 2020 · cited 63× · PMID 32391381 · DOI 10.3389/fmolb.2020.00071
Verify or expand the search:
- PubMed search for NCT04102150
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Valemetostat Tosylate
Trials testing the same drug.
- NCT07303387 — Efficacy and Safety of the Valemetostat in Patients With Selected Solid Tumors. · Phase 2 · not yet recruiting
- NCT06632977 — Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial · Phase 2 · recruiting
- NCT04703192 — Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Periphe · Phase 2 · active not recruiting
Other recruiting trials for Adult T-cell Leukemia/Lymphoma
Currently open trials in the same condition.
- NCT07388563 — Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma · Phase 1 · recruiting
- NCT07356245 — Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma · Phase 2 · recruiting
- NCT07159620 — Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients · Phase 2 · recruiting
- NCT05978141 — A Registry for People With T-cell Lymphoma · recruiting
Other Daiichi Sankyo Co., Ltd. trials
Trials by the same sponsor.
- NCT06074705 — A Study of DS-1471a In Subjects With Advanced Solid Tumors · Phase 1 · terminated
- NCT05606094 — Real-World Observational Study to Describe Treatment Patterns in Patients With HER2-Positive Locally Advanced or Metasta · completed
- NCT04914520 — Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects · Phase 1 · completed
- NCT04818398 — Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects · Phase 1 · completed
- NCT04821674 — Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04102150 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo Co., Ltd.
- Last refreshed: 10 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04102150.
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