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

NCT05552937 | Recruiting Phase 2

• 1 other identifier: ICP-CL-00901
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

DLBCL

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Evaluation by the Independent Review Committee (IRC).

  1-3 years approximately

Secondary Outcomes (13)

• Objective Response Rate (ORR)

  1-3 years approximately

• Disease Control Rate (DCR)

  1-3 years approximately

• Duration of Response (DOR)

  1-3 years approximately

• Progression Free Survial (PFS)

  1-3 years approximately

• Time to progression (TTP)

  1-3 years approximately

Study Arms (1)

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.

Drug: Tafasitamab and Lenalidomide

Interventions

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.

Tafasitamab and Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (1)

The First Afflicated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

tafasitamab; Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Huili Zhou

CONTACT

86 571-87236685; Yixuelunli123@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: September 6, 2021
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

CN (1)