A Real-world Study of Tafasitamab in Combination With Lenalidomide in Patients withR/R DLBCL
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1 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
The combination of Tafasitamab and lenalidomide based treatment was selected according to the specific conditions of patients
Other Names:
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| Cohort 2 Tafa combination therapy group followed by sequential CAR T or transplantation |
Drug: Tafasitamab Injection
The combination of Tafasitamab and lenalidomide based treatment was selected according to the specific conditions of patients
Other Names:
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Outcome Measures
Primary Outcome Measures
- objective remission rate [at the end of Cycle 2 (each cycle is 28 days)]
Defined as the proportion of patients with CR and PR
Secondary Outcome Measures
- Progression-free survival (PFS) [1year after induction therapy]
The time between the start of treatment and when the tumor progresses or the patient dies
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Patients who, as determined by the treating physician, would benefit from Tafa treatment
Exclusion Criteria:
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Known allergy or metabolic disorder to any drug in the regimen
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Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period
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Have a history of uncontrolled medical disease (including uncontrolled diabetes, severe heart, lung, liver, renal insufficiency), blood, endocrine system, and other malignancies
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Severe mental illness
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Patients deemed unsuitable for inclusion by the investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | China |
Sponsors and Collaborators
- Zhao Weili
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY2023-006