Ofatumumab + HDMP + Lenalidomide for Chronic Lymphocytic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for Chronic Lymphocytic Leukemia (CLL), a cancer affecting the blood and bone marrow. The study aims to determine if starting with ofatumumab (a monoclonal antibody) and high-dose methylprednisolone (a corticosteroid), followed by ofatumumab and lenalidomide (an immunomodulatory drug), can effectively control CLL over the long term. It also evaluates the safety and tolerability of this treatment combination. Individuals with untreated, advanced, or active CLL may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot use other anti-cancer treatments or experimental drugs during the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that the combination of ofatumumab, high-dose methylprednisolone (HDMP), and lenalidomide is generally well-tolerated by people with chronic lymphocytic leukemia (CLL). Research suggests that this treatment is safe and effective, particularly for those who haven't had much success with other treatments.
Researchers have found that the treatment's effects on the body are manageable. While some side effects may occur, they are not severe enough to outweigh the benefits for many patients.
In summary, earlier studies suggest that this treatment is likely safe, giving researchers confidence as they continue to test it.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for Chronic Lymphocytic Leukemia (CLL) that typically involve chemotherapy and monoclonal antibodies, the combination of Ofatumumab, High Dose Methylprednisolone (HDMP), and Lenalidomide offers a fresh approach by leveraging a synergistic immunotherapy regimen. Ofatumumab is a monoclonal antibody that specifically targets CD20 on the surface of B cells, while Lenalidomide modulates the immune system and enhances the body's response against cancer cells. The addition of HDMP provides potent anti-inflammatory effects and can help reduce tumor burden rapidly. Researchers are excited about this treatment because it potentially offers a more targeted attack on cancer cells with fewer side effects compared to traditional chemotherapy, and it might work for patients who haven't responded well to existing options.
What evidence suggests that this trial's treatments could be effective for Chronic Lymphocytic Leukemia?
Research has shown that a combination of three treatments—ofatumumab, high-dose methylprednisolone (HDMP), and lenalidomide—works well for treating chronic lymphocytic leukemia (CLL). In this trial, participants will receive this combination regimen followed by consolidative therapy. One study found this combination effective and generally well-tolerated in people who have not previously received other CLL treatments. Ofatumumab targets cancer cells, HDMP is a steroid that reduces inflammation and slows cancer cell growth, and lenalidomide boosts the immune system to attack cancer cells. Together, these treatments have shown promising results in helping people with CLL manage their condition for a longer time.24567
Who Is on the Research Team?
Celeste Bello, M.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Are You a Good Fit for This Trial?
This trial is for adults with untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), who have not had other cancers in the last 5 years, except certain skin or 'in situ' cancers. Participants must meet specific disease criteria, be physically able to follow the study plan, and women of childbearing age must use two forms of birth control due to risks from one of the drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Ofatumumab with high dose Methylprednisolone followed by Ofatumumab and Lenalidomide
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- High Dose Methylprednisolone
- Lenalidomide
- Ofatumumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania
Celgene Corporation
Industry Sponsor
Mark Alles
Celgene Corporation
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania
Sol J. Barer
Celgene Corporation
Chief Medical Officer since 2006
PhD in Organic and Physical Chemistry from Rutgers University