The trial is taking place at:
T

Tampere University Hospital | Tampere Heart Hospital

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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)

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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

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

Trial contacts and locations

261

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Central trial contact

Incyte Corporation Call Center (US); Incyte Corporation Call Center (ex-US)

Data sourced from clinicaltrials.gov

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