A Phase 3 study of Tafasitamab plus Lenalidomide in patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
- Conditions
- Diffuse large B-cell lymphoma (DLBCL)MedDRA version: 21.0Level: LLTClassification code: 10012883Term: Diffuse lymphoma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505579-53-00
- Lead Sponsor
- Incyte Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 81
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.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method