Lymphoma

To assess the safety and tolerability of tafasitamab alone or in combination with other drugs in Japanese participants with Non-Hodgkins Lymphoma (NHL)

Incyte Study ID:
INCMOR 0208-102
CT.gov ID:
NCT04661007
Eudra ID:
N/A
Sponsor:
Incyte Biosciences Japan GK
Collaborator:
N/A
Study Contact Information:
+81 3-3507-5795 or [email protected]
Recruiting
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Clinical Study Purpose

This is an open-label, multicenter study to evaluate safety and tolerability, determine the RP2Ds of tafasitamab alone in Japanese participants with R/R NHL, or to evaluate efficacy and safety of tafasitamab in combination with lenalidomide in Japanese participants with R/R DLBCL, or tafasitimab in combination with lenalidomide plus R-CHOP in Japanese participants with previously untreated DLBC, or tafasitimab in combination with lenalidomide in Japanese participants with previously R/R DLBC.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Lymphoma
    • PRODUCT
  • Drug: tafasitamab
  • Drug: lenalidomide
  • Drug: parsaclisib
  • Drug: R-CHOP
    • COLLABORATORS
    N/A
    DATE
    Dec 2020 - May 2025
    TYPE
    Interventional
    PHASE
    Phase 1/Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Group 1 only: Biopsy-proven participants with relapsed or refractory NHL of DLBCL, FL or MZL.
    • Groups 3, 4a and 5 only: Biopsy-proven participants with relapsed or refractory DLBCL.

    Exclusion Criteria

    • Any other histological type of lymphoma.
    • History of prior non-hematologic malignancy.

    Clinical Study Locations

    Location
    Status
    Location
    NATIONAL CANCER CENTER HOSPITAL
    TOKYO, Japan, 104-0045
    Status
    Recruiting
    Location
    NATIONAL CANCER CENTER HOSPITAL EAST
    CHIBA, Japan, 277-8577
    Status
    Recruiting
    Location
    NATIONAL HOSPITAL ORGANIZATION KYUSHU CANCER CENTER
    FUKUOKA, Japan, 811-1395
    Status
    Recruiting
    Location
    OSAKA UNIVERSITY HOSPITAL
    SUITA-SHI, Japan, 565-0871
    Status
    Recruiting
    Location
    AICHI CANCER CENTER HOSPITAL
    AICHI, Japan, 464 8681
    Status
    Recruiting
    Location
    TOHOKU UNIVERSITY HOSPITAL
    MIYAGI, Japan, 980-8574
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCMOR 0208-102
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    65
    Primary Outcome
    Open

    Part 1,2 and 3 : Treatment Emergent Adverse Events (TEAE'S)

    Timeframe: Approximately 2 years

    Part 4: Objective Response

    Timeframe: Approximately 27 months

    Secondary Outcome
    Open

    Part 1,2, 3 and 4 : Cmax of tafasitamab

    Timeframe: Approximately 27 months

    Part 1, 2, 3 and 4: Cmin of tafasitamab

    Timeframe: Approximately 27 months

    Part 4: Complete Response

    Timeframe: Approximately 27 months

    Part 4: Duration of Response

    Timeframe: Approximately 27 months

    Part 4: Progression-Free Survival

    Timeframe: Approximately 27 months

    Part 4: Overall Survival

    Timeframe: Approximately 27 months

    Part 4: Overall Response Rate

    Timeframe: Approximately 27 months

    Part 4: Treatment Emergent Adverse Events (TEAE'S)

    Timeframe: Approximately 2 years