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.
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Follicular Lymphoma, Marginal Zone Lymphoma
In brief
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.
Key facts
- Study ID
- NCT04680052
- Run by
- Incyte Corporation
- People needed
- 654
- Starts
- 2021-04-15
- Expected to finish
- 2028-08-09
- Last updated by the study team
- 2025-12-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify 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
Where it is running
- Marin Cancer Care — Greenbrae, California, United States
- The Oncology Institute of Hope and Innovation — Pasadena, California, United States
- Sharp Memorial Hospital — San Diego, California, United States
- Middlesex Hospital Cancer Center — Middletown, Connecticut, United States
- Smilow Cancer Hospital — New Haven, Connecticut, United States
- Cancer Specialists of North Florida — Jacksonville, Florida, United States
- Brcr Medical Center, Inc — Plantation, Florida, United States
- Asclepes Research Centers — Weeki Wachee, Florida, United States
- Northwest Georgia Oncology Centers,P.C — Marietta, Georgia, United States
- Straub Medical Center — Honolulu, Hawaii, United States
- Des Moines Oncology Research Association — Des Moines, Iowa, United States
- Baptist Health Lexington — Lexington, Kentucky, United States
- Norton Cancer Institute — Louisville, Kentucky, United States
- Tulane University — New Orleans, Louisiana, United States
- University of Maryland-Greenebaum Cancer Center — Baltimore, Maryland, United States
- Cancer Center For Blood Disorders — Bethesda, Maryland, United States
- Barbara Ann Karmanos Cancer Hospital — Detroit, Michigan, United States
- Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc) — Saint Louis Park, Minnesota, United States
- Hattiesburg Clinic Hematology — Hattiesburg, Mississippi, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- Nyu Clinical Cancer Center — New York, New York, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- Integris Cancer Institute — Oklahoma City, Oklahoma, United States
- Charleston Hematology Oncology Associates — Charleston, South Carolina, United States
- John Muir Health Clinical Research Center — Concord, California, United States
Full record on ClinicalTrials.gov
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