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 (InMIND)
Active, not recruiting
- Conditions
- Follicular Lymphoma, Marginal Zone Lymphoma
- Registration Number
- jRCT2021210065
- Lead Sponsor
- Incyte Biosciences Japan G.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 618
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method