Authorised Therapeutic confirmatory (Phase III) Diffuse large B-cell lymphoma (DLBCL)

A Phase 3 study of Tafasitamab plus Lenalidomide in patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

EU CTIS ID: 2023-505579-53-00

What this study is testing

To determine the efficacy of tafasitamab plus lenalidomide in study participants with R/R DLBCL who are not eligible for HDC/ASCT, using the 2014 Lugano Classification.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Aged ≥ 18 years at the time of consent. 2. Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures. 3. Histologically-confirmed diagnosis of any of the following: a. Diffuse large B-cell lymphoma not otherwise specified b. T cell/histiocyte-rich large B-cell lymphoma c. Epstein-Barr virus positive DLBCL of the elderly d. Grade 3b follicular lymphoma e. Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse f. Evidence of histological transformation from an earlier diagnosis of low grade lymphoma (ie, an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL, with a subsequent DLBCL relapse 4. Willingness to undergo tumor biopsy requirements for the study, including an incisional, excisional, or core needle lymph node or tissue biopsy (or have archival lymph node or tissue block from the most recent biopsy, not to exceed 3 years prior to C1D1). 5. Willingness to undergo bone marrow biopsy/aspirate collections as appropriate. Please refer to protocol for a complete list of inclusion criteria.

You likely can't join if

  • 1. Any other histological type of lymphoma according to the WHO 2016 classification of lymphoid neoplasms, including: a. primary mediastinal (thymic) large B-cell lymphoma b. Burkitt lymphoma c. Primary refractory DLBCL, defined as disease progressing in the course of the first line treatment, and/or showing a response of less than a PR to first-line treatment, or disease recurrence/progression within < 6 months from the completion of first-line therapy. d. History of double- or triple-hit DLBCL, characterized by simultaneous detection of MYC with BCL2 and/or BCL6 translocation(s) as per fluorescence in situ hybridization. MYC, BCL2, BCL6 testing prior to study enrollment is not required. 2. History or evidence of CNS lymphoma (primary and secondary). 3. Prior treatment with CD19-targeted therapy or IMiDs (eg, thalidomide, lenalidomide) 4. Participants who, within 30 days prior to Cycle 1 Day 1, have: a. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy b. Undergone major surgery or suffered from significant traumatic injury c. Received live vaccines or have an anticipated need for such vaccination while receiving study treatment d. Required parenteral antimicrobial therapy for active, intercurrent infections 5. Have undergone ASCT within the period ≤ 3 months prior to signing consent. If an ASCT was performed > 3 months prior to signing consent, full hematological recovery must be demonstrated before enrollment into the study. Please refer to protocol for a complete list of exclusion criteria.

The study team makes the final eligibility decision.

Where it's taking place

  • Turkey
  • Israel
  • Serbia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Turkey; Israel; Serbia. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.