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Trial Title:
A Real-world Study of Tafasitamab in Combination With Lenalidomide in Patients withR/R DLBCL
NCT ID:
NCT05883709
Condition:
Diffuse Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lenalidomide
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Tafasitamab Injection
Description:
The combination of Tafasitamab and lenalidomide based treatment was selected according to
the specific conditions of patients
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Other name:
lenalidomide
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.
Criteria for eligibility:
Study pop:
Recurrent or refractory diffuse large B-cell lymphoma after systemic therapy
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Country:
China
Start date:
July 1, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Zhao Weili
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05883709
