NCT04102150 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2025-02-10

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

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
healthy Volunteers: false
minimum Age: 20 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: Valemetostat Tosylate
label
DS-3201b
type
EXPERIMENTAL

interventions

arm Group Labels
DS-3201b
description
Once a day, 200 mg, oral administration
name
Valemetostat Tosylate
other Names
DS-3201b
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 25
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Overall response rate (ORR) assessed by central evaluation organization
time Frame
Through the end of the study (within approximately 5 years)

secondary Outcomes

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

Full study description

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).

Source references

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.
pmid
36150143
type
DERIVED

Source notices and limitations

Discovery and provenance

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portant histone methyltransferases involved with chromatin folding.[<a href="#cit/section_12.13">13</a>] A multicenter phase II study (<a href="/clinicaltrials/NCT04102150">NCT04102150</a>) enrolled 25 patients with relapsed or refractory ATL, 24 of whom had prior therapy with mogamulizumab.[<a href="#cit/section_12.14">14</a>] W
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ne methyltransferases involved with chromatin folding.[<a href="#cit/section_12.13">13</a>] A multicenter phase II study (<a href="/clinicaltrials/NCT04102150">NCT04102150</a>) enrolled 25 patients with relapsed or refractory ATL, 24 of whom had prior therapy with mogamulizumab.[<a href="#cit/section_12.14">14</a>] With a median
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Peripheral T-Cell Non-Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version
source update dates
context
Updated: May 13, 2025
datetime
2025-05-13T12:00:00Z
display
May 13, 2025
source url
https://www.cancer.gov/types/lymphoma/hp/peripheral-t-cell-lymphoma-pdq

Preserved source evidence · Independent clinical review pending · Not medical advice