Lenalidomide + Blinatumomab for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of lenalidomide and blinatumomab when given together in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on other anti-cancer treatments or certain HIV medications with similar side effects. Any prior therapy must have been completed at least 4 weeks before joining the study.
Is the combination of Lenalidomide and Blinatumomab safe for treating lymphoma?
Lenalidomide has been shown to be generally safe in humans, with common side effects including low blood cell counts and fatigue. However, it may increase the risk of certain other cancers. Safety data specifically for the combination with Blinatumomab is not provided, but Lenalidomide alone has a favorable safety profile in lymphoma treatment.12345
What makes the drug combination of Lenalidomide and Blinatumomab unique for treating lymphoma?
The combination of Lenalidomide and Blinatumomab is unique because Lenalidomide is an immunomodulatory drug that enhances the immune system's ability to fight cancer by altering the tumor environment and boosting T and natural-killer cells, while Blinatumomab is a monoclonal antibody that helps direct the immune system to target cancer cells. This combination leverages both drugs' strengths to potentially improve treatment outcomes in lymphoma.12678
What data supports the effectiveness of the drug Lenalidomide + Blinatumomab for Lymphoma?
Research shows that Lenalidomide, a drug that helps the immune system fight cancer, has been effective in treating various types of B-cell lymphomas, especially when combined with other treatments. It has shown impressive results in patients who did not respond to previous therapies, suggesting it could be beneficial in combination with Blinatumomab for lymphoma.126910
Who Is on the Research Team?
Joseph M. Tuscano
Principal Investigator
City of Hope Comprehensive Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults with various types of relapsed Non-Hodgkin Lymphoma who have tried at least two prior treatments and are not eligible for standard cures. They must have measurable disease, normal organ function tests, no brain metastases or uncontrolled illnesses, and not be pregnant or breastfeeding. HIV-positive patients can join if they meet certain conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive blinatumomab IV continuously on days 1-56 and lenalidomide PO on days 29-49
Consolidation
Patients achieving response receive blinatumomab IV on days 1-7 and lenalidomide PO on days 1-21, repeating every 28 days for up to 6 cycles
Maintenance
Patients receive lenalidomide PO on days 1-21, repeating every 28 days for up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blinatumomab
- Lenalidomide
Blinatumomab is already approved in European Union, United States for the following indications:
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
- High-risk first relapse BCP-ALL
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
- First or second complete remission with minimal residual disease (MRD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor