New Oral Treatment for Relapsed or Refractory CLL and Richter Syndrome

Finding effective treatment options can be especially difficult for people living with chronic lymphocytic leukemia (CLL) and Richter syndrome (RS)—a rare but aggressive complication of CLL or small lymphocytic lymphoma (SLL). Many patients facing these diagnoses have already gone through several lines of therapy, often with limited success, making the search for new and better treatments all the more urgent.

A recent clinical trial explored the combination of two oral medications—venetoclax and duvelisib—to determine their safety and effectiveness in treating these conditions.

The Advantages of Oral Treatments

Venetoclax (Venclexta), when used with rituximab (Rituxan), is a highly effective treatment for CLL but requires two years of therapy, including six months of intravenous infusions. However, receiving oral medication can improve a patient’s quality of life as it is more convenient. 

Duvelisib (Copiktra) is an oral medication approved by the FDA for patients with relapsed or refractory CLL after two prior treatments.

Discussing new treatment options with your healthcare team is essential. Clinical trials like this one help expand treatment possibilities and improve outcomes for patients. You can stay informed with HealthTree’s Clinical Trial Finder and use the different filters to discover personalized options. 

A Clinical Trial with an All-Oral Combination

This phase 2 clinical trial included 38 patients with relapsed or refractory CLL/SLL or Richter syndrome who received at least one prior treatment or no venetoclax treatment in the past year. 

The treatment plan involved:

• Duvelisib at 25 mg twice daily for seven days.
• Adding venetoclax on day 8, beginning at a low dose and gradually increasing to 400 mg per day over several weeks.
• Patients with Richter syndrome could start venetoclax at a higher dose and reach 400 mg in five days.
• After one year of treatment, patients with no detectable cancer cells in their bone marrow could stop therapy and restart if their disease returned.
• Those with detectable cancer cells continued venetoclax alone and had the option to stop later if they achieved complete remission.

Effectiveness of Treatment

Relapsed/Refractory CLL Results

• 97% of CLL patients responded to treatment 
• After 12 months, 72% of patients continued to respond to treatment, with 44% achieving a complete remission.
• 68% remained progression-free after three years

Richter Syndrome Results

• 30% of the patients with Richter Syndrome achieved a complete remission, including one who received a stem cell transplant and remained in remission for over two years.

Progression-free survival rates were lower for high-risk patients with specific genetic mutations (47%)  and those previously treated with BTK inhibitors (46%).

What Are the Side Effects of This Combination? 

• The most common side effects were low blood cell counts, with 86% of patients having low white blood cell counts (neutropenia), and 58% of patients with low platelet counts (thrombocytopenia). 
• Other common side effects included diarrhea (63%), nausea (55%), liver enzyme changes, high blood pressure, and headaches.
• Serious side effects included colitis (inflammation of the large intestine), tumor lysis syndrome (a condition where cancer cells break down too quickly), infections, and febrile neutropenia (fever caused by having low white blood cells).
• Five patients had to discontinue because of the serious side effects that they were experiencing

Conclusion

This study showed that an all-oral, time-limited treatment with venetoclax and duvelisib is effective for patients with relapsed or refractory CLL/SLL and Richter syndrome, including those with high-risk disease. Side effects were common but considered manageable. These results support further research into this combination therapy for CLL/SLL and Richter syndrome patients.

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Source: 

• A Phase 2 Study of Duvelisib and Venetoclax in Patients with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Richter’s Syndrome (RS)