Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory DLBCL

Official title

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

Overview

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

Interventions

• Drug Tafasitamab and Lenalidomide
  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.

Primary outcome measures

• Objective response rate (ORR) [Time frame: 1-3 years approximately]

Secondary outcome measures (12)

• Objective Response Rate (ORR) [Time frame: 1-3 years approximately]
• Disease Control Rate (DCR) [Time frame: 1-3 years approximately]
• Duration of Response (DOR) [Time frame: 1-3 years approximately]
• Progression Free Survial (PFS) [Time frame: 1-3 years approximately]
• Time to progression (TTP) [Time frame: 1-3 years approximately]
• Time to response (TTR) [Time frame: 1-3 years approximately]
• Overall Survival (OS) [Time frame: 1-3 years approximately]
• Safety of Lenalidomide combined with Tafasitamab according to the frequency and severity of adverse events (AEs). [Time frame: 2 years]
• Potential immunogenicity of Tafasitamab. [Time frame: 2 years]
• Maximum serum concentration (Cmax) [Time frame: 2 years]
• Time to maximum serum concentration (tmax) [Time frame: 2 years]
• Apparent trough serum concentration before dosing (Cpd) [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

• Age >18 years.
• Histologically confirmed diagnosis of DLBCL not otherwise specified (NOS); T cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma, Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukaemia) into DLBCL with a subsequent DLBCL relapse are also eligible.
• Patients received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy.
• Patients must meet the following laboratory criteria at screening.
• Patients must use an effective barrier method of contraception.
• In the opinion of the investigator the patients must be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events; be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.

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:

• not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy.
• undergone major surgery or suffered from significant traumatic injury.
• received live vaccines.
• required parenteral antimicrobial therapy for active, intercurrent infections.
• Patients who:

• were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN).
• have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
• have undergone previous allogenic stem cell transplantation.
• have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
• concurrently use other anticancer or experimental treatments.
• Prior history of malignancies other than DLBCL.
• Patients with:

• positive hepatitis B and/or C serology.
• known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).
• CNS lymphoma involvement.
• history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent.
• history or evidence of severe hepatic impairment (total serum bilirubin > 3 mg/dL).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Afflicated Hospital, College of Medicine, Zhejiang University — Hangzhou

Publications

• 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. PMID 41176775

Identifiers

NCT: NCT05552937 · ICP-CL-00901

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗