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This is a A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tafasitamab and Lenalidomide | Experimental | Tafasitamab and lenalidomide will be coadministered for up to 12 cycles (28 days per cycle).followed by tafasitamab monotherapy (in participants with stable disease or better) until treatment withdrawal criteria are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafasitamab and Lenalidomide | Drug | Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle. Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Evaluation by the Independent Review Committee (IRC). | 1-3 years approximately |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Evaluated by the IRC according to cheson 2007 and cheson 2014. | 1-3 years approximately |
| Disease Control Rate (DCR) | 1-3 years approximately |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have other histological type of lymphoma,primary refractory DLBCL,a history of "double/triple hit" genetics.
Patients who have, within 14 days prior to Day 1 dosing:
Patients who:
Prior history of malignancies other than DLBCL.
Patients with:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huili Zhou | Contact | 86 571-87236685 | Yixuelunli123@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Afflicated Hospital, College of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41176775 | Derived | You J, Chen W, Yan Z, Tian D, Yi H, Feng Y, Zhang M, Xing T, Wang Z, Zhao W, Xu P. Anti-CD19 antibody tafasitamab therapy for relapsed or refractory diffuse large B-cell lymphoma: a case series. Anticancer Drugs. 2026 Feb 1;37(2):123-127. doi: 10.1097/CAD.0000000000001774. Epub 2025 Oct 30. |
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| ID | Term |
|---|---|
| C000613469 | tafasitamab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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|
| Duration of Response (DOR) | 1-3 years approximately |
| Progression Free Survial (PFS) | 1-3 years approximately |
| Time to progression (TTP) | 1-3 years approximately |
| Time to response (TTR) | 1-3 years approximately |
| Overall Survival (OS) | 1-3 years approximately |
| Safety of Lenalidomide combined with Tafasitamab according to the frequency and severity of adverse events (AEs). | 2 years |
| Potential immunogenicity of Tafasitamab. | 2 years |
| Maximum serum concentration (Cmax) | 2 years |
| Time to maximum serum concentration (tmax) | 2 years |
| Apparent trough serum concentration before dosing (Cpd) | 2 years |
| Area under the serum concentration versus time curve from time 0 to the time t of the last quantifiable concentration (AUC0-t) | 2 years |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |