SYMPATICO (PCYC-1143-CA)

SYMPATICO study

Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma

Disease:

Lymphoma -> mantle cell lymphoma (MCL)

Summary:

Mantle cell lymphoma (MCL) is a rare form of non-Hodgkin lymphoma, a cancer of white blood cells. Symptoms include enlarged lymph nodes, high temperature, sweating at night, weight loss and enlarged organs in the abdomen. The cells are also often found in the bone marrow, blood and gut.

This trial is for patients who have been treated for mantle cell lymphoma before, and the disease has continued to grow or returned. Patients will all receive ibrutinib, taken by mouth. This medication works by targeting an important part of the cancer cell called “Bruton’s tyrosine kinase (Btk)” which causes the cell to die. In addition, patients will have a 50:50 chance of receiving a placebo or medication new drug called venetoclax (Venclexta), also taken orally. Venetoclax blocks a protein in lymphoma cells called (bcl-2), which causes them to “self-destruct”.

The aim of the trial is to see whether the addition of venetoclax improves outcomes compared with ibrutinib alone.

Eligibility:

Include, but not limited to, the following:

- A diagnosis of mantle cell lymphoma (MCL) that has continued to grow (refractory) or returned (relapsed) after at least one, but no more than, lines of treatment
- No prior treatment with a Btk inhibitor such as ibrutinib
- No other active cancer (other than some cancers cured with minor operations like skin cancer)
- No other major health problems
- No previous use of these types of medications

Contact person:

Louise Hay

Email louise.hay@health.wa.gov.au

Phone 6457 7600

Principal Investigator:

Dr Chan Cheah

08 6457 7600

Sponsor:

Pharmacyclics

Phase:

III

Protocol Number:

PCYC-1143-CA

Trial Registration Number:

NCT03112174

Clinical Trials.gov

ANZ Clinical Trial Registry