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)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT04809467
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tafasitamab — DRUG
    tafasitamab will be administered at a protocol defined dose once a week for cycles 1-3 and every other week from cycle 4 until progression.
  • parsaclisib — DRUG
    parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.

Study Details

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.

Key Dates

Start date
Sep 16, 2021
Status verified
Feb 2026
Primary completion
Oct 22, 2024
Completion
Oct 22, 2024

Study Design

Enrollment
54 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: tafasitamab + parsaclisib
    Participants will be assigned to disease specific cohorts based on the histology of their underlying disease. Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL

Primary Outcome Measure

Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) [ Time Frame: up to 1092 days ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of Alabama At Birmingham Comprehensive Cancer CenterBirminghamAlabama35205-
University of Southern CaliforniaLos AngelesCalifornia90089-
Community Health Network, Inc.IndianapolisIndiana46250-
Indiana Blood and Marrow TransplantationIndianapolisIndiana46237-
Norton Cancer InstituteLouisvilleKentucky40202-
Cancer Center For Blood DisordersBethesdaMaryland20817-
University of MichiganAnn ArborMichigan48109-
Clinical Research AllianceNew Hyde ParkNew York11042-
Ohio State UniversityColumbusOhio43210-
Jefferson University HospitalsPhiladelphiaPennsylvania19107-

Find similar trials in Birmingham, AL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Alabama At Birmingham Comprehensive Cancer Center· Birmingham, ALUniversity of Southern California· Los Angeles, CACommunity Health Network, Inc.· Indianapolis, INIndiana Blood and Marrow Transplantation· Indianapolis, INNorton Cancer Institute· Louisville, KYCancer Center For Blood Disorders· Bethesda, MD

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