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

Zhao Weili15 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Diffuse Large B-cell Lymphoma

Interventions

Tafasitamab InjectionDRUG

The combination of Tafasitamab and lenalidomide based treatment was selected according to the specific conditions of patients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Outcomes

Primary Outcomes

objective remission rate

Defined as the proportion of patients with CR and PR

Time frame: at the end of Cycle 2 (each cycle is 28 days)

Secondary Outcomes

Progression-free survival (PFS)

The time between the start of treatment and when the tumor progresses or the patient dies

Time frame: 1year after induction therapy

Data from ClinicalTrials.gov

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