Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients

Part of paid clinical trials in Morristown, New Jersey.

Sponsor
Incyte Corporation
Study ID
NCT05222555
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Tafasitamab — DRUG
    tafasitamab will be administered intravenously at protocol defined timepoints
  • Lenalidomide — DRUG
    lenalidomide will be administered orally at protocol defined timepoints

Study Details

This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.

Key Dates

Start date
Jul 19, 2022
Status verified
Jan 2026
Primary completion
Jul 17, 2024
Completion
Nov 30, 2027

Study Design

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

Arms

  • Experimental: Treatment (Tafasitamab + Lenalidomide)
    Treatment: Tafasitamab will be combined with lenalidomide in R/R DLBCL patients. Dose: Cohort 1: The dose of tafasitamab will be level 1 high dose in combination with the approved dose Cohort 2: The dose of tafasitamab will be level 2 high dose in combination with the approved dose Expansion Cohort: The dose of tafasitamab will be the dose that is deemed safe and tolerable as determined from cohort 1 \& cohort 2 Treatment consisting of tafasitamab and lenalidomide combination will be administered until disease progression, unacceptable toxicity, or discontinuation for any other reason, whichever comes first. Lenalidomide can be given for up to 12 cycles in total, after which patients can continue with tafasitamab as monotherapy until progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Any Treatment-emergent Adverse Event (TEAE) [ Time Frame: up to approximately 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Morristown Memorial HospitalMorristownNew Jersey07960-6459-
Texas Oncology-Baylor Charles A. Sammons Cancer Center - USORDallasTexas75246-2092-
Vista OncologyOlympiaWashington98506-

Find similar trials in Morristown, NJ

By research site
Morristown Memorial Hospital· Morristown, NJTexas Oncology-Baylor Charles A. Sammons Cancer Center - USOR· Dallas, TXVista Oncology· Olympia, WA

Related Studies