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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.

NCT04680052

Description:

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.

Related Conditions:
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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.
  • Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: INCMOR 0208-301
  • NCT ID: NCT04680052

Conditions

  • Follicular Lymphoma
  • Marginal Zone Lymphoma

Interventions

DrugSynonymsArms
tafasitamabArm A : tafasitamab + rituximab + lenalidomide
rituximabArm A : tafasitamab + rituximab + lenalidomide
lenalidomideArm A : tafasitamab + rituximab + lenalidomide
placeboArm B : placebo+rituximab+lenalidomide

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm A : tafasitamab + rituximab + lenalidomideExperimentalAdult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)
  • tafasitamab
  • rituximab
  • lenalidomide
Arm B : placebo+rituximab+lenalidomidePlacebo ComparatorAdult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)
  • rituximab
  • lenalidomide
  • placebo

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS) in FL population
Time Frame:Up to 6 years
Safety Issue:
Description:Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.

Secondary Outcome Measures

Measure:Progression Free Survival (PFS) in FL and MZL populations
Time Frame:Up to 6 years
Safety Issue:
Description:Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.
Measure:Complete Response in FL population
Time Frame:Up to 6 years
Safety Issue:
Description:Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit
Measure:Minimal Residual Disease-negativity rate in FL and MZL Population
Time Frame:14 months
Safety Issue:
Description:Defined as less than 1 residual tumor cell per 10^4 normal cells in peripheral blood and bone marrow.
Measure:Overall Survival in FL Population
Time Frame:Up to 6 years
Safety Issue:
Description:Defined as survival from time of study randomization to death of any cause.
Measure:Complete Response in Overall population
Time Frame:Up to 6 years
Safety Issue:
Description:Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit
Measure:Overall Survival in overall Population
Time Frame:Up to 6 years
Safety Issue:
Description:Defined as survival from time of study initiation to death of any cause.
Measure:Best Overall Response Rate in FL and overall population
Time Frame:Up to 6 years
Safety Issue:
Description:Defined as proportion of participants whose best overall response was a complete response (CR) or partial response (PR).
Measure:Duration of Response in FL and overall population
Time Frame:Up to 6 years
Safety Issue:
Description:Defined as the time to the first response to evidence of progression.
Measure:Quality-of-Life Assessments in FL and overall populations
Time Frame:Up to 6 years
Safety Issue:
Description:Defined as a patient self evaluation questionnaire
Measure:Safety: Number of participants with TEAE's
Time Frame:13 months
Safety Issue:
Description:Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Last Updated

April 22, 2021