Triple Therapy for Chronic Lymphocytic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a combination of three drugs to help patients with chronic lymphocytic leukemia (CLL) and Richter transformation (RT). The drugs work by boosting the immune system to fight cancer and stopping cancer cells from growing.
Who Is on the Research Team?
Nitin Jain, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Adults with chronic lymphocytic leukemia (CLL) or Richter transformation (RT), who have had prior treatments for CLL or are untreated with high-risk features, can join. They must be in good general health based on specific blood tests and agree to use effective contraception. Excluded are those with severe lung disease, certain heart conditions, uncontrolled hypertension, active infections, hepatitis B/C or HIV, recent major surgery or other cancer treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Patients receive ipilimumab IV over 90 minutes on day 1 and ibrutinib PO QD. Treatment repeats every 3 weeks for up to 4 cycles.
Treatment Part B
Patients receive ipilimumab IV over 90 minutes, nivolumab IV over 30 minutes on day 1, and ibrutinib PO QD starting day 7. Treatment repeats every 3 weeks for up to 4 cycles.
Extension
Patients who benefit from treatment may continue ipilimumab every 12 weeks and nivolumab every 4 weeks for up to 2 years.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- Ibrutinib
- Ipilimumab
- Nivolumab
Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor