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

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05883709
• Other study ID #: KY2023-006
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2023
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

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

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhao Weili

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free survival (PFS)	The time between the start of treatment and when the tumor progresses or the patient dies	1year after induction therapy