Trial · NCT04703192
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
NCT04703192, Phase 2, Active not recruiting, Daiichi Sankyo; results first posted 2024-07-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01). Trials, record NCT04703192. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04703192
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
- NCT number
- NCT04703192
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 155 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
- Interventions
- Valemetostat Tosylate
- First posted
- 2021-01-11
- Last updated
- 2026-11-06
- Other registries' IDs
- eudract:2020-004954-31
- Results first posted
- 2024-07-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | From baseline until disease progression or death (whichever occurs first), up to approximately 23 months | For the relapsed/refractory peripheral T-cell lymphoma (PTCL) cohort, objective response rate (ORR) is defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), assessed by blinded independent central review (BICR), among participants with centrally confirmed PTCL eligible histology. |
| Primary | Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2) | From the time the informed consent form is signed up to 30 days after last dose, up to 23 months | Treatment-emergent adverse events (TEAEs) were defined as new AEs or pre-existing conditions that worsen in National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade after the first dose of study drug and up to 30 days after the last dose of study drug. |
| Secondary | Plasma Concentrations of DS-3201a and CALZ-1809a After Administration of Valemetostat Tosylate Monotherapy | Cycle 1 Day 1, 8, 15 Predose; Cycle 1 Day 1 (1, 2, 4, 5 hours Postdose); Cycle 2 Day 1 Predose; Cycle 3 Day 1 to Cycle 5 Day 1 Predose (each cycle is 28 days) | Total and unbound DS-3201a (free form of valemetostat tosylate) and total CALZ-1809a (major metabolite) concentration in plasma will be assessed. |
| Secondary | Duration of Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | Time from the date of first documented response (CR or PR) until documented disease progression (progressive or relapsed disease) based on BICR assessments or death from any cause (whichever occurs first), up to approximately 56 months | Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of disease progression (progressive or relapsed disease) based on BICR assessments or to death due to any cause, whichever occurs first. |
| Secondary | Percentage of Participants With Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | From baseline to date of first documented objective response of CR, up to approximately 56 months | Complete response rate is the percentage of participants achieving CR as the BOR based on BICR assessments. |
| Secondary | Duration of Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | Time from the date of first documented CR until documented disease progression (progressive or relapsed disease) based on BICR assessments or death from any cause (whichever occurs first), up to approximately 56 months | Duration of complete response is defined as the time from the date of the first documentation of CR to the date of the first documentation of disease progression (progressive or relapsed disease) based on BICR assessments or to death due to any cause, whichever occurs first. |
| Secondary | Percentage of Participants With Partial Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | From baseline to date of first documented objective response of PR, up to approximately 56 months | Partial response rate is the percentage of participants achieving PR as the BOR based on BICR assessment. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | From the time the informed consent form is signed up to 30 days after last dose |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | From baseline until disease progression or death (whichever occurs first), up to approximately 23 months | Efficacy Analysis Set for Cohort 1 is defined as all subjects who received at least 1 dose of valemetostat tosylate and had an eligible PTCL subtype that was confirmed by central hematopathology review. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2) | From the time the informed consent form is signed up to 30 days after last dose, up to 23 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Plasma Concentrations of DS-3201a and CALZ-1809a After Administration of Valemetostat Tosylate Monotherapy | Cycle 1 Day 1, 8, 15 Predose; Cycle 1 Day 1 (1, 2, 4, 5 hours Postdose); Cycle 2 Day 1 Predose; Cycle 3 Day 1 to Cycle 5 Day 1 Predose (each cycle is 28 days) | |||
| SECONDARY | Duration of Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | Time from the date of first documented response (CR or PR) until documented disease progression (progressive or relapsed disease) based on BICR assessments or death from any cause (whichever occurs first), up to approximately 56 months | |||
| SECONDARY | Percentage of Participants With Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | From baseline to date of first documented objective response of CR, up to approximately 56 months | |||
| SECONDARY | Duration of Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | Time from the date of first documented CR until documented disease progression (progressive or relapsed disease) based on BICR assessments or death from any cause (whichever occurs first), up to approximately 56 months | |||
| SECONDARY | Percentage of Participants With Partial Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | From baseline to date of first documented objective response of PR, up to approximately 56 months | |||
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | From the time the informed consent form is signed up to 30 days after last dose |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1) | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 43.7 | 95% Confidence Interval 34.6 to 53.1 | percentage of participants | |
| Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2) | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | 22 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 133 | |
| Overall Study | STARTED | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma (ATCL) | 22 | |
| Overall Study | COMPLETED | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 32 | |
| Overall Study | COMPLETED | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma (ATCL) | 2 | |
| Overall Study | NOT COMPLETED | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 101 | |
| Overall Study | NOT COMPLETED | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma (ATCL) | 20 |
Source ClinicalTrials.gov
Adverse events272
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 47 | 133 | 139 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | 11 | 22 | 41 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 35 | 133 | 104 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | 4 | 22 | 13 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 18 | 133 | 60 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | 0 | 22 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 38 | 133 | 56 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | 5 | 22 | 5 |
| other | Nausea | Gastrointestinal disorders | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 23 | 133 | 28 |
| other | Nausea | Gastrointestinal disorders | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | 4 | 22 | 5 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 52 | 133 |
| Total, all-cause mortality | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | 16 | 22 |
| Total, other adverse events | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 120 | 133 |
| Total, other adverse events | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | 22 | 22 |
| Total, serious adverse events | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | 53 | 133 |
| Total, serious adverse events | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | 15 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39486433 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) vs Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma: deaths from any cause | Trial comparisons |
| Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) vs Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04703192
GET https://conductscience.org/api/trials/v1/NCT04703192/events?page=2