ACE-LY-308

ECHO study

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination with Acalabrutinib (ACP-196) in Subjects with Previously Untreated 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 not been treated for their lymphoma before. Patients will all receive as a minimum, standard treatment using bendamustine (chemotherapy) and rituximab (a lymphoma targeting antibody) given through an intravenous drip. In addition, patients will have a 50:50 chance of receiving a placebo or a new drug called acalabrutinib, taken by mouth. This medication works by targeting an important part of the cancer cell called Bruton’s tyrosine kinase (Btk), which causes the cells to die.

Eligibility:

Include, but not limited to, the following:

- Patients must be aged above 65 years of age
- A diagnosis of mantle cell lymphoma (MCL) with no previous treatment
- No other active cancers (other than some cancers cured with minor operations like skin cancer)
- No other major health problems

Contact person:

Louise Hay

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

Phone 6457 7600

Principal Investigator:

Dr Chan Cheah

Phone 08 6457 7600

Sponsor:

Acerta Pharma

Phase:

III

Protocol Number:

ACE-LY-308

Trial Registration Number:

NCT02972840

Clinical Trials.gov

ANZ Clinical Trial Registry