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Not yet recruitingNCT05883709Updated Jun 1, 2023

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

An observational study in Diffuse Large B-cell Lymphoma, sponsored by Zhao Weili. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-01.

Sponsored by Zhao Weili · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 15 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Zhao Weili is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
15 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugTafasitamab Injection

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

    Also known as: lenalidomide

06

What researchers measure

Primary outcomes

  1. objective remission rate

    Defined as the proportion of patients with CR and PR

    Time frame: at the end of Cycle 2 (each cycle is 28 days)

Secondary outcomes

  1. Progression-free survival (PFS)

    The time between the start of treatment and when the tumor progresses or the patient dies

    Time frame: 1year after induction therapy

07

Study locations

1 site
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05883709
Lead sponsor
Zhao Weili
Responsible party
Zhao Weili (Prof., Ruijin Hospital) — Sponsor-investigator
First posted
Jun 1, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Dec 30, 2023 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Jun 1, 2023

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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