Clinical Trial TitleTafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients (frontMIND)
National Clinical Trial Number:NCT04824092
Clinical Trial Protocol Description:
The two main forms of lymphoma are Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). Non-Hodgkin Lymphoma is the most common type of lymphoma. Diffuse large B cell lymphoma (DLBCL) is the most common type of NHL. Most patients with newly diagnosed DLBCL are treated with the standard anti-lymphoma therapy called R-CHOP. This immuno-chemotherapy consists of four medicines including chemotherapy: cyclophosphamide, doxorubicin, vincristine, and prednisone (abbreviated as “CHOP”): and the monoclonal antibody rituximab (abbreviated as “R”).
The purpose of this study is to investigate whether adding tafasitamab plus lenalidomide to the standard R-CHOP treatment it is more effective and safe compared with R-CHOP treatment alone in newly diagnosed, previously untreated patients with higher risk DLBCL. If you agree to participate in this study, you will be assigned randomly (this means by chance, like flipping a coin) to either of two groups:
- Investigational group: tafasitamab in combination with lenalidomide
- Control group: tafasitamab placebo in combination with lenalidomide placebo
All participants will have a 50% (1 in 2) chance of receiving tafasitamab and lenalidomide in addition to R-CHOP (investigational group) and a 50% chance of receiving tafasitamab placebo and lenalidomide placebo in addition to R-CHOP (control group). Neither you nor the study doctor can choose your treatment group and neither you nor the study doctor will know which treatment you are assigned to. This is done to make sure the results of the study cannot be influenced by anyone.
Tafasitamab or tafasitamab placebo will be administered directly into the vein (intravenously) as a weekly infusion which lasts approximately 2 hours. Lenalidomide or lenalidomide placebo capsule will be taken whole and swallowed with water once a day for 10 consecutive days every 3 weeks. The entire treatment for both groups is given in treatment cycles for a total duration of approximately 18 weeks (6 cycles of 3 weeks duration, each). Participation in the study may last for up to 5 years.
During the study treatment period participants will need to visit the clinic usually once per week. An end-of-treatment visit, including safety evaluation, will be performed between 4 to 8 weeks after a participant received their last treatment. After the end-of-treatment visit, participants will enter the “follow up period.” During this period, the participant’s health status including regular tumor assessments, will be evaluated in the clinic approximately every three months for the first two years of the follow-up period, and then every six months for the period of at least three years.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older with diffuse large B-cell lymphoma with no prior treatment for this cancer.
- Have adequate heart, liver and kidney function.
- Are able to swallow pills.
You will be excluded from the study if any of the following criteria apply to you:
- Have disease that is unclassifiable, or is Hodgkin lymphoma or primary cutaneous DLBCL, leg type; primary DLBCL of the central nervous system; DLBCL arising from chronic lymphocytic leukemia or indolent lymphoma.
- Have a history of receiving radiation therapy to greater than or equal to 25% of your bone marrow for other diseases.
- Test positive for hepatitis B, C, or HIV.
- Have a known active systemic bacterial, viral, fungal, or other infection at screening.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.