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J-MINDNCT04661007

To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)

StatusActive, Not Recruiting
PhasePhase 1/2
Primary completion

At risk: Primary endpoint(s) modified.

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Record History

All 27 versions: 22 with changes below, 5 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results posted: Oct 21, 2026 Show 4 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints: 8 to 16
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date changed from estimate of Dec 31, 2026 to Jul 1, 2025v26
  3. Primary and study completion dates pushed to Dec 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 65 to confirmed 72
    • Site details revised at 23 of 23 sites
    v24
  4. Site details revised at 3 of 23 sitesv21
  5. Site details revised at 1 of 23 sitesv19
Show 16 earlier versionsHide 16 earlier versions
  1. Phase: Phase 1 to Phase 1/2
    • Eligibility criteria expanded, about 13 words
    v18
  2. Site details revised at 1 of 23 sitesv17
  3. Study sites: 22 to 23v16
  4. Study sites: 20 to 22v15
  5. Site details revised at 1 of 20 sitesv13
  6. Study sites: 19 to 20v12
  7. Study sites: 18 to 19v11
  8. Study sites: 16 to 18v10
  9. Study sites: 15 to 16v9
  10. Study sites: 14 to 15
    • Primary completion date: Jun 3, 2025 to May 31, 2025
    • Study completion date: Jul 23, 2026 to Jul 20, 2026
    v8
  11. Primary completion date: Jul 24, 2023 to Jun 3, 2025v7 Show 7 more changesShow less
    • Eligibility criteria expanded, about 28 words
    • Primary endpoints: 1 to 2
    • Enrollment target: 49 to 65
    • Study sites: 6 to 14
    • Study completion date: Nov 21, 2023 to Jul 23, 2026
    • Secondary endpoints: 2 to 8
    • Study arms: 3 to 4
  12. Study sites: 5 to 6v6
  13. Study sites: 4 to 5v5
  14. Enrollment target: 96 to 49
    • Study sites: 2 to 4
    • Study completion date: Jul 24, 2023 to Nov 21, 2023
    v4
  15. Primary and study completion dates pushed to Jul 24, 2023v3
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Dec 10, 2020 to Dec 15, 2020
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Phase 1, Parts 1 and 2; Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Timeframe: up to 1066 days
Phase 1, Parts 1 and 2; Number of Participants With Any ≥Grade 3 TEAE
Timeframe: up to 1066 days
Phase 1, Part 1 and Part 2 (Groups 3, 4a, and 5); Number of Participants With Any Dose-limiting Toxicity (DLT)
Timeframe: up to 28 days
Phase 2, Part 4: Objective Response (OR) as Determined by an Independent Review Committee (IRC) According to Lugano Criteria
Timeframe: up to 723 days

Secondary (16)

Phase 1, Parts 1 and 2; Cmax of Tafasitamab
Phase 1, Parts 1 and 2; Cmin of Tafasitamab
Phase 2, Part 4; Cmax of Tafasitamab
Phase 2, Part 4; Cmin of Tafasitamab
Phase 1, Part 2: Percentage of Participants With the Indicated Response Per Investigator Assessment of Response According to the Lugano Criteria
Show 11 moreShow less
Phase 1, Part 2: Percent Reduction in the Sum of the Products of Perpendicular Diameters for Multiple Lesions in up to 6 Target Measurable Nodes/Extranodal Sites Assessed by Computed Tomography as Per Investigator Assessment of Lugano Criteria Response
Phase 2, Part 4: Complete Response (CR) as Determined by an IRC According to Lugano Criteria
Phase 2, Part 4: Kaplan-Meier Estimate of Duration of Response (DOR) as Determined by an IRC According to Lugano Criteria
Phase 2, Part 4: Kaplan-Meier Estimate of Progression-free Survival (PFS) as Determined by an IRC
Phase 2, Part 4: Kaplan-Meier Estimate of Overall Survival
Phase 2, Part 4: OR as as Per Investigator Assessment of Response According to the Lugano Criteria
Phase 2, Part 4: CR as Per Investigator Assessment of Response According to the Lugano Criteria
Phase 2, Part 4: DOR as Per Investigator Assessment of Response According to the Lugano Criteria
Phase 2, Part 4: PFS as Per Investigator Assessment of Response According to the Lugano Criteria
Phase 2, Part 4: Number of Participants With Any TEAE
Phase 2, Part 4: Number of Participants With Any ≥Grade 3 TEAE

Arms and interventions

Part 1 : tafasitimab monotherapyExperimental

Dose-finding to evaluate the safety and tolerability and to determine the RP2Ds of single-agent tafasitamab in Japanese participants with NHL. Part 1 consists of 1 group (Group 1) to evaluate weight-based doses of tafasitamab.

Part 2 : tafasitamab combination therapyExperimental

tafasitamab will be combined with lenalidomide (Group 3) or parsaclisib (Group 4a) in R/R DLBCL participants or lenalidomide plus R-CHOP (Group 5) in previously untreated DLBCL participants. Modified tafasitamab dosing when combined with lenalidomide (Group 2) in participants with R/R DLBCL will be evaluated to determine the recommended clinical dose. The dose of tafasitamab will be based on the weight-based RP2D that is deemed safe and tolerable in Part 1.

Part 3 : Dose Expansion of tafasitamab +parsaclisibExperimental

tafasitamab in combination with parsaclisib will be further evaluated in Group 4b at RP2D determined in Part 2

Part 4: tafasitamab combination therapyExperimental

tafasitamiab in combination with lenalidomide will be further evaluated in Group 6 at RP2D determined in Part 2.

Drugs: tafasitamab, lenalidomide, parsaclisib, R-CHOP

Sites

23 sites in 1 country