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

NCT05883709 | Unknown FDA Drug

• 1 other identifier: KY2023-006
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression-free survival (PFS)

  1year after induction therapy

Study Arms (2)

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

Cohort 2

Tafa combination therapy group followed by sequential CAR T or transplantation

Drug: Tafasitamab Injection

Interventions

Tafasitamab Injection DRUG

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

Also known as: lenalidomide

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recurrent or refractory diffuse large B-cell lymphoma after systemic therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhao Weili: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

tafasitamab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: June 1, 2023
• Study Start: July 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

CN (1)