NIH seeks leukemia patients for studies
Fatigue. Weight loss. Night sweats. Frequent infections. Some people with these symptoms are shocked when their doctor diagnoses them with chronic lymphocytic leukemia (CLL), a slow-moving cancer of the blood and bone marrow.
Although the disease is serious, a diagnosis is not an immediate death sentence; in fact, doctors don’t treat early-stage CLL at all, preferring to monitor its progression first. Most people live a decade or more with the disease.
Now researchers at the National Institutes of Health are seeking volunteers for several clinical trials related to advanced stages of the condition.
Most people diagnosed with CLL are adults over age 70. According to the Mayo Clinic, Caucasians are more likely to be diagnosed with CLL. Exposure to pesticides or other chemicals such as Agent Orange has been linked to a higher risk of CLL.
The exact cause of CLL is still unclear, however.
Several studies recruiting
One study will investigate a drug called duvelisib. It will be administered when patients with CLL stop responding to a standard treatment called ibrutinib.
“Ibrutinib is a very effective treatment for CLL, but some patients develop genetic mutations in their cancer, which prevents ibrutinib from working,” said Dr. Clare Sun, the study’s principal investigator. “Duvelisib is a relatively new drug that blocks a critical pathway in leukemia cells.”
Once enrolled, patients will travel to NIH’s National Heart, Lung, and Blood Institute (NHLBI) in Bethesda for the trial, which includes medical screenings and blood tests.
Another study will investigate an FDA-approved drug called venetoclax to see why it is so effective. Researchers will check for changes in the immune system and genetic makeup of the tumor during therapy. Participants will receive venetoclax and medical monitoring for the first five weeks of treatment before being transitioned to their local hematologist/oncologist for continued treatment.
“Venetoclax is a very effective treatment for CLL, both as a first-line treatment and for patients with relapsed CLL,” said Dr. Chris Pleyer, the study’s principal investigator “Venetoclax is generally well tolerated but requires close monitoring during the first few weeks of therapy. The NIH team will offer expert medical care during this challenging period.”
The other clinical trial will test a combination of ibrutinib and immunotherapy to treat CLL. Researchers hope to find effective cures for high-risk CLL, so they are testing ibrutinib along with an additional class of drug called an immune checkpoint blockade.
“While most patients initially respond well to ibrutinib, patients can develop resistance to ibrutinib, leading to disease progression,” said Dr. Inhye Ahn. “Investigators at the NIH aim to improve the outcome of the high-risk CLL by recruiting patients’ own immune system to attack CLL cells.” An immune checkpoint blockade “unleashes the breaks in natural immune cells and helps them recognize and attack cancer cells,” according to Dr. Ahn.
All three clinical trials are open to adults over age 18 with CLL.
They require several visits to NIH’s clinic in Bethesda, Maryland, (parking will be reimbursed). Compensation information is available by phone.
For more information, contact the NIH Clinical Center Office of Patient Recruitment at 1-800-411-1222 or email prpl@cc.nih.gov.