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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05883709
Enrollment
15
Registered
2023-06-01
Start date
2023-07-01
Completion date
2024-12-30
Last updated
2023-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-cell Lymphoma

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.

Interventions

DRUGTafasitamab Injection

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

Sponsors

Zhao Weili
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
objective remission rateat the end of Cycle 2 (each cycle is 28 days)Defined as the proportion of patients with CR and PR

Secondary

MeasureTime frameDescription
Progression-free survival (PFS)1year after induction therapyThe time between the start of treatment and when the tumor progresses or the patient dies

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026