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.
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
Drug | Synonyms | Arms |
---|
tafasitamab | INCMOR00208, MOR00208 | Arm A : tafasitamab + rituximab + lenalidomide |
rituximab | | Arm A : tafasitamab + rituximab + lenalidomide |
lenalidomide | | Arm A : tafasitamab + rituximab + lenalidomide |
placebo | | Arm 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
Name | Type | Description | Interventions |
---|
Arm A : tafasitamab + rituximab + lenalidomide | Experimental | Adult 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+lenalidomide | Placebo Comparator | Adult 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 |
Trial Keywords
- MOR00208
- INCMOR00208
- tafasitamab
Last Updated
August 12, 2021