JPRN-jRCT2021210065
Active, not recruiting
Phase 3
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
Eiji Ueda0 sites618 target enrollmentJanuary 18, 2022
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Follicular Lymphoma, Marginal Zone Lymphoma
- Sponsor
- Eiji Ueda
- Enrollment
- 618
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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