Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Elizabeth Brem (uci)

Description

Summary

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

Keywords

Follicular Lymphoma, Marginal Zone Lymphoma, MOR00208, INCMOR00208, tafasitamab, Lymphoma, B-Cell, Marginal Zone, Rituximab, Lenalidomide, tafasitamab + rituximab + lenalidomide

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
  • Willingness to avoid pregnancy or fathering children
  • In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)
  • Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy
  • Documented relapsed, refractory, or PD after treatment with systemic therapy
  • ECOG performance status of 0 to 2

You CAN'T join if...

  • Women who are pregnant or breastfeeding.
  • Any histology other than FL and MZL or clinical evidence of transformed lymphoma
  • Prior non-hematologic malignancy
  • Congestive heart failure
  • HCV positivity, chronic HBV infection or history of HIV infection
  • Active systemic infection
  • CNS lymphoma involvement
  • Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1
  • Prior use of lenalidomide in combination with rituximab

Locations

  • Sharp Memorial Hospital
    San Diego California 92123 United States
  • Marin Cancer Care
    Greenbrae California 94904 United States
  • The Oncology Institute of Hope and Innovation
    Pasadena California 91105 United States
  • John Muir Health Clinical Research Center
    Concord California 94520-2266 United States

Lead Scientist at University of California Health

  • Elizabeth Brem (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 32 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
Links
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/ Refractory (R/ R) Follicular Lymphoma or Marginal Zone Lymphoma.
ID
NCT04680052
Phase
Phase 3 Lymphoma Research Study
Study Type
Interventional
Participants
About 654 people participating
Last Updated