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Clinical Trials/JPRN-jRCT2021210065
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.

Registry
who.int
Start Date
January 18, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Eiji Ueda

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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