Clinical trial · Observational
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
NCT05883709CI-TRIAL-00066851unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tafasitamab Injection | Drug | Tafasitamab | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- 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)
- interventionNames
- Drug: Tafasitamab Injection
- label
- Cohort 2
- description
- Tafa combination therapy group followed by sequential CAR T or transplantation
- interventionNames
- Drug: Tafasitamab Injection
Primary outcomes (1)
- measure
- objective remission rate
- timeFrame
- at the end of Cycle 2 (each cycle is 28 days)
- description
- Defined as the proportion of patients with CR and PR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.