Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients (frontMIND)
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ClinicalTrials.gov Identifier: NCT04824092 |
Recruitment Status :
Recruiting
First Posted : April 1, 2021
Last Update Posted : August 24, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | March 22, 2021 | ||||
First Posted Date ICMJE | April 1, 2021 | ||||
Last Update Posted Date | August 24, 2022 | ||||
Actual Study Start Date ICMJE | May 11, 2021 | ||||
Estimated Primary Completion Date | June 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
PFS-INV [ Time Frame: From randomization to the first occurrence of disease progression or relapse as assessed by the investigator, or death from any cause, whichever occurs earlier (up to 43 months) ] Progression-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients | ||||
Official Title ICMJE | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL) | ||||
Brief Summary | This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Diffuse Large B-cell Lymphoma | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
880 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 2026 | ||||
Estimated Primary Completion Date | June 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Major Inclusion Criteria:
Major Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Argentina, Australia, Austria, Canada, Colombia, Czechia, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, New Zealand, Philippines, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04824092 | ||||
Other Study ID Numbers ICMJE | MOR208C310 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | MorphoSys AG | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | MorphoSys AG | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | MorphoSys AG | ||||
Verification Date | August 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |