A Real-world Study of Tafasitamab in Combination With Lenalidomide in Patients withR/R DLBCL

Study Overview
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Brief Summary
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To evaluate the real-world efficacy of Tafasitamab combined with Lenalidomide base regimen in patients with relapsed or refractory DLBCL, with objective response rate as the primary end point.

Detailed Description
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This study retrospectively collected the data of patients previously treated with Tafa and divided them into two coords according to different protocols received. Cohort 1 was Tafa combined treatment group, which could include Tafa combined with lenalidomide, Tafa combined with Lenalidomide plus BTK inhibitor, Tafa combined with Lenalidomide plus chemotherapy (including ADC). Cohort 2 was treated with sequential CAR T or graft after Tafa combination therapy.

Official Title
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A Real-world Study Evaluating the Safety and Efficacy of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Conditions
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Diffuse Large B-cell Lymphoma

Intervention / Treatment
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* Drug: Tafasitamab Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pathological diagnosis of DLBCL, including but not limited to non-specific DLBCL (NOS-DLBCL); Large B-cell lymphoma (THRLBCL) rich in T cells/histiocytes; EBV positive DLBCL (EBV-positive DLBCL); According to the revised REAL/WHO classification, it was grade 3b follicular lymphoma, including DLBCL component, followed by DLBCL recurrence. In addition, patients with low-grade lymphomas such as follicular lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia have histological evidence of transformation to DLBCL and subsequent recurrence Patients who, as determined by the treating physician, would benefit from Tafa treatment Exclusion Criteria: Known allergy or metabolic disorder to any drug in the regimen Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period Have a history of uncontrolled medical disease (including uncontrolled diabetes, severe heart, lung, liver, renal insufficiency), blood, endocrine system, and other malignancies Severe mental illness Patients deemed unsuitable for inclusion by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Tafa combination therapy group, which could include Tafa combined with lenalidomide, Tafa combined with Lenalidomide plus BTK inhibitors, Tafa combined with Lenalidomide plus chemotherapy (including ADC) | Drug: Tafasitamab Injection<br>* The combination of Tafasitamab and lenalidomide based treatment was selected according to the specific conditions of patients<br>* Other names: lenalidomide;|
| Cohort 2<br>Tafa combination therapy group followed by sequential CAR T or transplantation | Drug: Tafasitamab Injection<br>* The combination of Tafasitamab and lenalidomide based treatment was selected according to the specific conditions of patients<br>* Other names: lenalidomide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective remission rate | Defined as the proportion of patients with CR and PR | at the end of Cycle 2 (each cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | The time between the start of treatment and when the tumor progresses or the patient dies | 1year after induction therapy |