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

Not yet recruiting

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Drug: Tafasitamab Injection

• Registration Number: NCT05883709
• Lead Sponsor: Zhao Weili

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.

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 Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-20
• Study First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Study First Posted: 2023-06-01
• Last Update Posted: 2023-06-01
• Study Start: 2023-07-01
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2	Tafasitamab Injection	Tafa combination therapy group followed by sequential CAR T or transplantation
Cohort 1	Tafasitamab Injection	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Progression-free survival (PFS)	1year after induction therapy	The time between the start of treatment and when the tumor progresses or the patient dies

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China