NHL29

NHL29

A Phase II Study of Ibrutinib, Rituximab and mini-CHOP therapy in very elderly patients with newly diagnosed diffuse large B-cell lymphoma

Disease:

Lymphoma -> diffuse large b-cell lymphoma (DLBCL)

Summary:

Diffuse large b-cell lymphoma (DLBCL) is the most common type of lymphoma. This form of cancer requires treatment when diagnosed, and commonly involves a combination of chemotherapy and immunotherapy medications.

In older patients this treatment often causes side effects such as low blood counts and severe infections.

This trial is for patients over 75 years old who have not been treated for their lymphoma. Patients will receive lower doses of standard chemotherapy (R-miniCHOP) with a new medication- ibrutinib (Imbruvica), taken by mouth. Ibrutinib works by targeting an important part of the cancer cell called Bruton’s tyrosine kinase (Btk), which causes the cells to die.

The aim of the trial is to see whether ibrutinib in combination with chemotherapy is safe and effective.

Eligibility:

Include, but not limited to, the following:

Include, but not limited to, the following:
- Patients must be aged above 75 years of age
- A new diagnosis of diffuse large B-cell lymphoma (DLBCL) with no previous treatment
- No evidence of the aggressive (fast) lymphoma developing from an indolent (slow) lymphoma
- No other active cancer (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

08 6457 7600

Sponsor:

Australasian Leukaemia and Lymphoma Group (ALLG)

Phase:

II

Protocol Number:

ALLG NHL29

Trial Registration Number:

ACTRN12615000551594

Clinical Trials.gov

ANZ Clinical Trial Registry