Leukemia - CLL, Lymphoma

A study evaluating safety, PK, and efficacy of tafasitamab and parsaclisib in participants with Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)

Incyte Study ID:
INCMOR 0208-101
CT.gov ID:
NCT04809467
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Clinical Study Purpose

The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Leukemia - CLL
  • Lymphoma
    • PRODUCT
  • Drug: tafasitamab
  • Drug: parsaclisib
    • COLLABORATORS
    N/A
    DATE
    Sep 2021 - Oct 2024
    TYPE
    Interventional
    PHASE
    Phase 1/Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    CANCER CENTER FOR BLOOD DISORDERS
    BETHESDA, MD, US, 20817
    Name
    HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID
    MADRID, Spain, 28223
    Name
    HOSPITAL UNIVERSITARIO 12 DE OCTUBRE
    MADRID, Spain, 28041
    Name
    HOSPITAL UNIVERSITARIO MARQUES DE VALDECILLA
    SANTANDER, Spain, 39008
    Name
    IRCCS ISTITUTO CLINICO HUMANITAS
    ROZZANO, Italy, 20089
    Name
    UNIVERSITY OF SOUTHERN CALIFORNIA
    LOS ANGELES, CA, US, 90089

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histologically confirmed R/R B-cell malignancy: DLBCL (THRLBCL, EBV–positive DLBCL of the elderly, Grade 3b FL, HGBL with MYC and BCL2 and/or BCL6 rearrangements, transformed lymphoma); MCL ((with cyclin D1 overexpression or t(11;14); FL (Grade 1, 2, 3a); MZL (extranodal, nodal, splenic) ; CLL, or SLL
    • Willingness to undergo biopsy

    Exclusion Criteria

    • Any other histological type of lymphoma
    • Primary or secondary CNS lymphoma

    Protocol Summary

    Incyte Study ID:
    INCMOR 0208-101
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    54
    Primary Outcome
    Open

    Phase 1b : Number of Treatment Emergent Adverse Events

    Timeframe: Up to 25 months

    Phase 1b : Incidence of Dose Limiting Toxicities

    Timeframe: 28 Days

    Secondary Outcome
    Open

    Phase 2a : Overall Response Rate

    Timeframe: Up to 25 months

    Pharmacokinetics Parameter : Cmax of tafasitamab

    Timeframe: Up to 24 months

    Pharmacokinetics Parameter : Cmin of tafasitamab

    Timeframe: Up to 24 months

    Pharmacokinetics Parameter : Tmax of tafasitamab

    Timeframe: Up to 24 months

    Pharmacokinetics Parameter : AUC(t) of tafasitamab

    Timeframe: Up to 24 months

    Pharmacokinetics Parameter : Ctrough of tafasitamab

    Timeframe: Up to 24 months