Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT03961672)

🧪 Interventions in This Study

• Duvelisib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Ability to understand and the willingness to sign a written informed consent document.
2. Histologically or flow cytometry confirmed diagnosis of B-CLL/small lymphocytic lymphoma (SLL) according to National Cancer Institute - Working Group (NCI-WG) 1996 guidelines. Patients who lack CD23 expression on their leukemia cells should be examined for (and found NOT to have) either t(11;14) or cyclin D1 overexpression, to rule out mantle cell lymphoma.
3. Participants have undergone \>= 1 prior chemotherapy-based or immunotherapy-based regimen or targeted therapy (e.g., inhibitors of BTK \[e.g., ibrutinib\], or BCL2 \[e.g., venetoclax\]) administered for \>= 2 cycles (\>= 8 weeks for oral therapies), and have had either documented disease progression or no response (i.e., stable disease \[SD\]) to the most recent treatment regimen.
4. Note: Individuals intolerant to ibrutinib therapy and those who progress on ibrutinib are eligible as long as they satisfy the above criteria.
5. Patients with CLL/SLL must demonstrate active disease meeting at least 1 of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria for requiring treatment:
6. A minimum of any one of the following constitutional symptoms:
7. Unintentional weight loss \> 10% within the previous 6 months prior to screening.
8. Extreme fatigue (unable to work or perform usual activities).
9. Fevers of greater than 100.5 degrees Fahrenheit (F) for \>= 2 weeks without evidence of infection.
10. Night sweats without evidence of infection.
11. Evidence of progressive marrow failure as manifested by the development of, or worsening of anemia or thrombocytopenia.
12. Massive (i.e., \> 6 cm below the left costal margin), progressive or symptomatic splenomegaly.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

• City of Hope Medical Center — Duarte, California
• Dana-Farber Cancer Institute — Boston, Massachusetts
• OHSU Knight Cancer Institute — Portland, Oregon

📞 Contact the Study Coordinator

Phone: (800) 826-4673

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Recurrent Chronic Lymphocytic Leukemia

• Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma — Houston, Texas
• Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial — Seattle, Washington
• Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery — Washington D.C., District of Columbia
• Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia — Duarte, California

Explore by condition: All Recurrent Chronic Lymphocytic Leukemia clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.