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

NCT ID: NCT05883709

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-30

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.

Conditions

Diffuse Large B-cell Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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)

Tafasitamab Injection

Intervention Type: DRUG

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

Cohort 2

Tafa combination therapy group followed by sequential CAR T or transplantation

Tafasitamab Injection

Intervention Type: DRUG

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

Interventions

Tafasitamab Injection

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

Intervention Type: DRUG

Other Intervention Names

lenalidomide

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhao Weili

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Countries

China

Other Identifiers

KY2023-006

Identifier Type: -

Identifier Source: org_study_id