Combining Tafasitamab and Lenalidomide for treating relapsed DLBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, single-arm, open-label multicenter study evaluates the safety and efficacy of Tafasitamab combined with Lenalidomide in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). The study aims to determine how well this combination therapy works in patients who have previously undergone treatment for DLBCL. Participants will receive the treatment and be monitored for safety and effectiveness over the course of the study. The study is designed to provide insights into a potential new treatment option for this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \>18 years.
2. 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.
3. 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.
4. Patients must meet the following laboratory criteria at screening.
5. Patients must use an effective barrier method of contraception.
6. 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:

1. Patients who have other histological type of lymphoma，primary refractory DLBCL，a history of "double/triple hit" genetics.
2. Patients who have, within 14 days prior to Day 1 dosing:

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

   1. were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN).
   2. have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
   3. have undergone previous allogenic stem cell transplantation.
   4. 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.
   5. concurrently use other anticancer or experimental treatments.
4. Prior history of malignancies other than DLBCL.
5. Patients with:

   1. positive hepatitis B and/or C serology.
   2. known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).
   3. CNS lymphoma involvement.
   4. 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.
   5. history or evidence of severe hepatic impairment (total serum bilirubin \> 3 mg/dL).

Where it's running

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

Study contacts

• Study coordinator: Huili Zhou
• Email: Yixuelunli123@163.com
• Phone: 86 571-87236685

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining Tafasitamab and Lenalidomide with Gemcitabine and Oxaliplatin for treating relapsed DLBCL

  This study is testing a new combination of medications for people with relapsed DLBCL to see if it works better than the standard treatment.

  Recruiting at 3 sites Phase 3 Beijing InnoCare Pharma Tech Co., Ltd. · Beijing and 19 other locations · NCT06521255

• Tafasitamab and Rituximab for newly diagnosed follicular lymphoma

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  Recruiting Phase 2 University of Washington · Seattle, Washington · NCT07731789

• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

  This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

• Rocbrutinib plus R-GemOx for relapsed/refractory DLBCL

  This early-stage study tests whether combining Rocbrutinib with R-GemOx is safe and shows promise in people with relapsed or refractory non-GCB DLBCL.

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• Real-world data and samples from frail or multiply treated large B‑cell lymphoma patients

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  Recruiting The Clatterbridge Cancer Centre NHS Foundation Trust · Liverpool, Merseyside · NCT07335120

• NK cell therapy with epcoritamab and tafasitamab for relapsed or treatment‑resistant B‑cell lymphoma

  This trial will try whether adding donor-derived ONC-PluReceptor NK cells to the antibodies epcoritamab and tafasitamab helps control relapsed or refractory CD19/CD20-positive B‑cell non‑Hodgkin lymphoma.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.