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HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL

NCT06792825 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-08-12

No results posted yet for this study

Summary

The study follows a Simon's two-stage phase II trial design to evaluate the safety and efficacy of tafasitamab added to rituximab and lenalidomide for two treatment-naïve, parallel, independent cohorts: follicular lymphoma (FL) and marginal zone lymphoma (MZ). Each cohort, FL and MZ, will be evaluated separately. This study is presented to the patient and consent is signed prior to the initiation of treatment for their primary malignancy.

Conditions

Interventions

DRUG

Tafasitamab

Tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15 and day 22.

DRUG

Rituximab

Rituximab 375 mg/m2 IV on day 1

DRUG

Lenalidomide

Lenalidomide 20 mg PO Day 1 through Day 21

Sponsors & Collaborators

  • Incyte Corporation

    collaborator INDUSTRY

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-07
Primary Completion
2029-07-08
Completion
2031-07-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06792825 on ClinicalTrials.gov