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

ConditionsFollicular LymphomaMarginal Zone Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasonic Cancer Center, University of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed marginal zone lymphoma

Histologically confirmed CD20+ follicular lymphoma stage 1, 2 or 3a

No prior systemic therapy for lymphoma

a nodal or extranodal (except spleen) mass >7cm in its greater diameter or,

Disqualifiers

HBV surface antigen (HBsAg) positive

HBV surface antigen (HBsAg) negative, HBV surface antibody (anti-HBs) positive and/or HBV core antibody (anti-HBc) positive, and detectable viral DNA

Hepatitis C virus (HCV) positive subjects with chronic hepatitis C, or subjects with an active hepatitis C infection requiring anti-viral medication (at time of randomization).

Known seropositive for or active viral infection with human immunodeficiency virus (HIV).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tafasitamab

    Drug

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

  • Rituximab

    Drug

    Rituximab 375 mg/m2 IV on day 1

  • Lenalidomide

    Drug

    Lenalidomide 20 mg PO Day 1 through Day 21

Treatment groups

65 Participants
are divided into 2 treatment groups
Group A: Follicular LymphomaExperimental treatment 3 interventions
Group B: Marginal Zone LymphomaExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Complete response (CR)

Estimate complete response (CR) at the end of study (after 12 cycles around 1 year) regimen of tafasitamab with lenalidomide and rituximab.

Time frame
1 year

Secondary outcomes

1

Complete response (CR)

Estimate complete response (CR) rate after 6 cycles of treatment.

Time frame
6 months
2

Overall response rate (ORR)

Estimate overall response rate (ORR) at the end of treatment (around 1 year).

Time frame
1 year
3

Progression of disease (POD24)

Estimate progression of disease (POD24) within 24 months (2 years)

Time frame
2 years
4

Progression free survival (PFS)

Estimate progression free survival (PFS) at 3 years after registration on study

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masonic Cancer Center, University of Minnesota

Lead sponsor

Incyte Corporation

Collaborator

Source ClinicalTrials.gov
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