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Clinical Trials

Taking part in a clinical trial may be the best treatment choice for some chronic lymphocytic leukemia (CLL) patients. Clinical trials are under way to improve remission rates for CLL. Today's standard treatments for cancer are based on earlier clinical trials. The Leukemia & Lymphoma Society continues to invest funds in CLL research.

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Current CLL Research and Clinical Trials

Current goals of CLL research are to

  • Develop truly curative therapies
  • Develop therapies that can work when others have failed
  • Decrease the side effects of treatment.

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A number of approaches are under study in clinical trials for the treatment of patients with CLL.

New Targeted Treatments. Specific new drug therapies under study in clinical trials for people with CLL include

  • Kinase Inhibitor Therapy. Some types of cancer can be treated by kinase inhibitor drugs that target specific enzymes within the cancer cells that are involved in cell growth and death. These drugs may be associated with fewer side effects than traditional chemotherapy agents.
    • Ibrutinib (Imbruvica®)
    • Acalabrutinib (Calquence®)
    • Zanubrutinib (BGB-3111)
    • Entospletinib (GS-9973)
    • Tirabrutinib (ONO-4059 or GS-4059)
    • Duvelisib (Copiktra®)
  • Monoclonal Antibodies
    • Ofatumumab (Arzerra®)
    • Cirmtuzumab (UC-961)
    • Obinutuzumab (Gazyva®)
    • Ublituximab (TG-1101)
  • Combinations of Antibodies with Other Targeted Drugs Being Investigated in Clinical Trials
    • Combinations with immunomodulatory drugs
    • Combination regimens of 3 or 4 drugs
    • Combinations with venetoclax (Venclexta®)

Immunomodulatory Drug. Lenalidomide (Revlimid®) is a targeted oral drug that is used to treat patients with myeloma. It stimulates a person’s own immune system to attack cancer cells. It also interferes with a wide variety of the components of the CLL microenvironment, the network of cells and molecules that allow CLL cells to survive and grow.

Early Treatment in CLL. Several ongoing trials are investigating the potential benefit of early treatment intervention, particularly in high-risk patients, with the use of less toxic novel agents.

National Veteran Affairs Tumor Registry Study. Exposure to Agent Orange has been associated with the development of CLL. This multi-center, retrospectivestudy focused on assessing the impact of Agent Orange exposure on the prognosis and management of CLL, using data from the National Veteran Affairs Tumor Registry. According to the study’s findings, exposure to Agent Orange was not associated with either unfavorable prognostic factors or shortened survival in the large veteran population examined.

CLL Natural History Study. This study helps researchers understand how CLL cells behave, which ultimately should help to develop new and better treatments for CLL patients. Applying new technologies to investigate the molecular basis and clinical indicators of CLL and small lymphocytic lymphoma (SLL) can clarify processes involved in disease progression and possibly lead to the discovery of targeted treatments. Patients may qualify for this clinical trial if they have never received treatment for their CLL.

CAR T-Cell Therapy. This type of immunotherapy consists of engineering a patient’s own immune cells to first recognize and then attack cancerous cells. This approach has shown very promising results in patients with blood cancers. The T cells are genetically engineered to produce receptors on their surface called “chimeric antigen receptors” (CARs). These receptors recognize and bind to a specific target found on the cancerous cells. To learn more about this therapy, click here

PD-1 Checkpoint Inhibitors. A vital part of the immune system is its ability to distinguish healthy cells in the body from those that it recognizes as foreign or harmful. The immune system depends on multiple checkpoints—molecules on certain immune cells that need to be either activated or turned off in order to start an immune response. Cancer cells sometimes take advantage of these checkpoints to escape the detection of active immune cells. Programmed cell death 1 (PD-1) is a checkpoint protein that is found on the surface of T cells. It normally acts as a type of “off switch” that helps keep immune cells from attacking healthy cells in the body. It accomplishes this when it attaches to a PD‑L1, a protein found on some normal cells and also in some cancer cells. When PD-1 binds to PD-L1, a message is sent to the T cell to leave the other cell alone. Some cancer cells have large amounts of PD-L1 receptors, which help them avoid an immune attack.

Checkpoint inhibitors are drugs created to target PD-1 or PD-L1, blocking their actions and allowing the immune system to recognize and eliminate cancer cells. Two examples are

  • Nivolumab (Opdivo®)
  • Pembrolizumab (Keytruda®)

For information about the drugs listed on this page, visit Drug Listings.

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