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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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ClinicalTrials.gov Identifier: NCT04680052
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Marginal Zone Lymphoma Drug: tafasitamab Drug: rituximab Drug: lenalidomide Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 618 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
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
Actual Study Start Date : April 16, 2021
Estimated Primary Completion Date : January 27, 2024
Estimated Study Completion Date : August 4, 2028


Arm Intervention/treatment
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)
Drug: tafasitamab
tafasitamab will be administered IV for 12 cycles
Other Names:
  • INCMOR00208
  • MOR00208

Drug: rituximab
Rituximab will be administered IV on cycles 1 - 5

Drug: lenalidomide
Lenalidomide will be administered PO for 12 cycles

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)
Drug: rituximab
Rituximab will be administered IV on cycles 1 - 5

Drug: lenalidomide
Lenalidomide will be administered PO for 12 cycles

Drug: placebo
placebo will be administered IV for 12 cycles




Primary Outcome Measures :
  1. Progression Free Survival (PFS) in FL population [ Time Frame: Up to 6 years ]
    Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) in FL and MZL populations [ Time Frame: Up to 6 years ]
    Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.

  2. Complete Response in FL population [ Time Frame: Up to 6 years ]
    Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit

  3. Minimal Residual Disease-negativity rate in FL and MZL Population [ Time Frame: 14 months ]
    Defined as less than 1 residual tumor cell per 10^4 normal cells in peripheral blood and bone marrow.

  4. Overall Survival in FL Population [ Time Frame: Up to 6 years ]
    Defined as survival from time of study randomization to death of any cause.

  5. Complete Response in Overall population [ Time Frame: Up to 6 years ]
    Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit

  6. Overall Survival in overall Population [ Time Frame: Up to 6 years ]
    Defined as survival from time of study initiation to death of any cause.

  7. Best Overall Response Rate in FL and overall population [ Time Frame: Up to 6 years ]
    Defined as proportion of participants whose best overall response was a complete response (CR) or partial response (PR).

  8. Duration of Response in FL and overall population [ Time Frame: Up to 6 years ]
    Defined as the time to the first response to evidence of progression.

  9. Quality-of-Life Assessments in FL and overall populations [ Time Frame: Up to 6 years ]
    Defined as a patient self evaluation questionnaire

  10. Safety: Number of participants with TEAE's [ Time Frame: 13 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680052


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
Show Show 33 study locations
Sponsors and Collaborators
Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04680052    
Other Study ID Numbers: INCMOR 0208-301
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
MOR00208
INCMOR00208
tafasitamab
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Rituximab
Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors