Status:
ACTIVE_NOT_RECRUITING
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.
Lead Sponsor:
Incyte Corporation
Conditions:
Follicular Lymphoma
Marginal Zone Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2028
Estimated Enrollment :
654 Patients enrolled
Trial Details
Trial ID
NCT04680052
Start Date
April 15 2021
End Date
August 9 2028
Last Update
December 22 2025
Active Locations (261)
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1
John Muir Health Clinical Research Center
Concord, California, United States, 94520-2266
2
Marin Cancer Care
Greenbrae, California, United States, 94904
3
The Oncology Institute of Hope and Innovation
Pasadena, California, United States, 91105
4
Sharp Memorial Hospital
San Diego, California, United States, 92123