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)

Incyte

Status and phase: Active, not recruiting; Phase 3

Conditions: Marginal Zone Lymphoma; Follicular Lymphoma

Treatments: Drug: rituximab; Drug: placebo; Drug: tafasitamab; Drug: lenalidomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04680052

INCMOR 0208-301

Details and patient eligibility

About

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

Enrollment: 654 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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654 participants in 2 patient groups, including a placebo group

Arm A : tafasitamab + rituximab + lenalidomide

Experimental group

Description:

Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

Treatment:

Drug: lenalidomide

Drug: tafasitamab

Drug: rituximab

Arm B : placebo+rituximab+lenalidomide

Placebo Comparator group

Description:

Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

Treatment:

Drug: lenalidomide

Drug: placebo

Drug: rituximab