BridgeMD
A Phase 3 study of Tafasitamab plus Lenalidomide in addition to Rituximab, versus Lenalidomide plus Rituximab in patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
EU CTIS ID: 2023-504684-16-00
What this study is testing
To compare the efficacy of tafasitamab and lenalidomide in addition to rituximab to the efficacy of placebo and lenalidomide in addition to rituximab in participants with relapsed/ refractory (R/R) FL.
- 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. Male and female participants at least 18 years of age who have a histologically confirmed Grade 1, 2 or 3a FL or histologically confirmed nodal MZL, splenic MZL, or extranodal MZL 2. Must have been previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy. This includes treatments such as rituximab monotherapy or chemotherapy plus immunotherapy with rituximab or obinutuzumab, with or without maintenance. 3. Must have documented relapsed, refractory, or progressive disease (PD) after treatment with systemic therapy a. Relapsed lymphoma: relapsed after initial response of CR or PR ≥ 6 months after prior therapy. b. Refractory lymphoma: achieved less than PR to the last treatment or achieved a CR or PR that lasted less than 6 months. c. Progressive lymphoma: PD after initial response of SD to prior therapy. Please refer to section 5.1 of the protocol for the full list of inclusion criteria.
You likely can't join if
- 1. Women who are pregnant or breastfeeding. 2. History of or current histology other than FL and MZL or clinical evidence of transformed lymphoma by investigator (INV) assessment. 3. History of radiation therapy to ≥ 25% of the BM for other diseases. 4. Active systemic infection. 5. Participants in a severely immunocompromised state. 6. Known CNS lymphoma involvement. Please refer to section 5.2 of the protocol for the full list of exclusion criteria.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Switzerland
- United Kingdom
- Israel
- Turkey
- Korea, Republic of
- Australia
- Japan
- Taiwan
- Canada
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 United States; Switzerland; United Kingdom; Israel; Turkey; Korea, Republic of and 4 more location(s). 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.