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NCT04703192

Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)

StatusActive, Not Recruiting
PhasePhase 2
Primary completion
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Record History

All 28 versions: 25 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 56 words
    • Study completion pushed from Aug 31, 2027 to Jun 19, 2029
    • Site details revised at 4 of 60 sites
    • Publications: details revised at 1 of 1 entry
  2. Study completion date: Feb 19, 2027 to Aug 31, 2027v27
  3. Study completion date: Sep 8, 2025 to Feb 19, 2027v26
  4. Results first posted: Jul 22, 2024v24
  5. Enrollment target: estimated 148 to confirmed 155
    • Secondary endpoints: details revised at 2 of 6 entries
    v23
Show 19 earlier versionsHide 19 earlier versions
  1. Study completion date: Apr 30, 2028 to Sep 8, 2025v22
  2. Study completion date: Sep 8, 2025 to Apr 30, 2028v21
  3. Primary completion date changed from estimate of Dec 3, 2023 to May 10, 2023
    • Study completion date: Mar 31, 2026 to Sep 8, 2025
    v20
  4. Secondary endpoints revised (6)v19
  5. Primary endpoints: 1 to 2v17 Show 4 more changesShow less
    • Eligibility criteria shortened, about 4 words
    • Enrollment target: 176 to 148
    • Secondary endpoints: 5 to 6
    • Study description shortened, about 6 words
  6. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 60 of 60 sites
    v15
  7. Study sites: 59 to 60v14
  8. Eligibility criteria expanded, about 18 wordsv13
  9. Study sites: 55 to 59v12
  10. Study sites: 50 to 55v11
  11. Study sites: 45 to 50v10
  12. Study sites: 37 to 45v9
  13. Study sites: 28 to 37v8
  14. Study sites: 16 to 28v7
  15. Study sites: 13 to 16v6
  16. Study sites: 5 to 13v5
  17. Eligibility criteria expanded, about 1 word
    • Study sites: 2 to 5
    v4
  18. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Primary completion date: Sep 29, 2023 to Dec 3, 2023
    • Start date changed from estimate of May 31, 2021 to Jun 3, 2021
    v3
  19. Start date: Mar 31, 2021 to May 31, 2021
    • Eligibility criteria shortened, about 71 words
    • Study description shortened, about 7 words
    • Study title expanded, about 1 word
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Timeframe: From baseline until disease progression or death (whichever occurs first), up to approximately 23 months
Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2)
Timeframe: From the time the informed consent form is signed up to 30 days after last dose, up to 23 months

Secondary (6)

Plasma Concentrations of DS-3201a and CALZ-1809a After Administration of Valemetostat Tosylate Monotherapy
Duration of Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Percentage of Participants With Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Duration of Complete Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Percentage of Participants With Partial Response After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
Show 1 moreShow less
Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)

Arms and interventions

Cohort 1: Relapsed/Refractory Peripheral T-Cell LymphomaExperimental

Participants who will receive 200 mg/day valemetostat tosylate and had an eligible peripheral T-cell lymphoma subtype that was confirmed by independent hematopathology central review.

Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/LymphomaExperimental

Participants who will receive 200 mg/day valemetostat tosylate and had an eligible adult T-cell leukemia/lymphoma subtype that was confirmed by the local pathologist/investigators and by documented positive anti-human T-cell leukemia virus type 1 (HTLV-1) antibody.

Drugs: Valemetostat Tosylate

Sites

60 sites in 12 countries

United States 14, Japan 10, France 7, Italy 5, South Korea 5, Spain 5, Taiwan 4, Canada 3, United Kingdom 3, Netherlands 2, Australia 1, Germany 1