Clinical Trial TitleZandelisib in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
National Clinical Trial Number:NCT03768505
Clinical Trial Protocol Description:
There are two main types of lymphoma: Hodgkin’s lymphoma (HL) and non-Hodgkin lymphoma (NHL). NHL is the most common type of lymphoma. Follicular lymphoma (FL) is one form of NHL. In follicular lymphoma, the white blood cells grow and survive longer than normal and this can cause problems such as large lymph glands, particularly in the neck, armpit, or groin areas. Some patients with follicular lymphoma develop large tumors in the abdomen.
Marginal zone lymphoma (MZL) is a group of indolent (slow growing) NHL B-cell lymphomas that begins forming in certain areas (the marginal zones) of lymph tissue. There are three types based on whether it forms in the spleen, lymph nodes, or other lymphoid tissue that contains a lot of B cells (a type of white blood cell).
Zandelisib is in a class of drugs called PI3K delta inhibitors, which block a part of the cancer cell development process and may ultimately cause lymphoma cell death. Zandelisib is being studied to see if it can control the growth of follicular lymphoma and marginal zone lymphoma.
Zandelisib is taken by mouth (orally) at the same time every day. Participation in the study may last up to 2 years and participants will be asked to complete at least 16 study visits.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older and have a diagnosis of follicular or marginal zone lymphoma and have received 2 or more treatment regimens for your disease.
- Have adequate blood, kidney and liver function.
- Have completed any prior systemic anti-cancer treatment at least 4 weeks or more before receiving Zandelisib.
- Are able to swallow pills.
You will be excluded from the study if any of the following criteria apply to you:
- Have transformed lymphoma or lymphoma of the central nervous system.
- Have had prior treatment with PI3K inhibitors.
- Have any uncontrolled clinically significant illness including, but not limited to, active infections requiring systemic antimicrobial therapy, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction.
- Test positive for hepatitis B, C, or HIV.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.