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.

Conditions

• Follicular Lymphoma
• Marginal Zone Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• tafasitamab — DRUG
  tafasitamab will be administered IV for 12 cycles
• rituximab — DRUG
  Rituximab will be administered IV on cycles 1 - 5
• lenalidomide — DRUG
  Lenalidomide will be administered PO for 12 cycles
• placebo — DRUG
  placebo will be administered IV for 12 cycles

Study Details

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.

Key Dates

Start date

Apr 15, 2021

Status verified

Dec 2025

Primary completion

Feb 23, 2024

Completion

Aug 9, 2028

Study Design

Enrollment

654 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A : tafasitamab + rituximab + lenalidomide
  Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)
• Placebo Comparator: Arm B : placebo+rituximab+lenalidomide
  Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

Primary Outcome Measure

FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First [ Time Frame: up to approximately 34 months ]

Locations (38)

Find similar trials in Concord, CA

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