BH39147

BH39147

A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination with Idasanutlin and Venetoclax in Patients with Relapsed or Refractory Follicular Lymphoma and Obinutuzumab or Rituximab in Combination with Idasanutlin and Venetoclax in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Disease:

Lymphoma -> follicular lymphoma (FL), diffuse large b-cell lymphoma (DLBCL)

Summary:

Follicular lymphoma (slow growing) and diffuse large b-cell lymphoma (fast growing) are forms of non-Hodgkin lymphoma, a cancer of the white blood cells. Symptoms include enlarged lymph nodes, high temperature, sweating at night, weight loss, low blood counts and enlarged organs in the abdomen.

This trial is for patients who have follicular lymphoma or diffuse large b-cell lymphoma which has returned after treatment. Patients will receive idasanutlin, venetoclax and either obinutuzumab or rituximab. Idasanutlin is a new drug taken by mouth, and works by ‘unleashing’ the body’s own powerful anti-cancer system against the lymphoma cells. Venetoclax is taken by mouth and primes lymphoma cells to undergo programmed cell death. Obinutuzumab and rituximab (a lymphoma targeting antibody) are given through an intravenous drip.

The aim of the trial is to see whether the combination of medications is effective and well tolerated in treating these forms of non-Hodgkin lymphoma.

Eligibility:

Include, but not limited to, the following:

- Patients must be aged 18 or over
- A diagnosis of follicular lymphoma or diffuse large B-cell lymphoma that has continued to grow (refractory) or returned (relapsed) after at least one line of treatment
- No other active cancers (other than some cancers cured with minor operations like skin cancer)
- No other major health problems

Contact person:

Zelda Herbst

Email zherbst@linear.org.au

Phone 08 6382 5100

Principal Investigator:

Dr Bradley Augustson

08 6457 7600

Sponsor:

F. Hoffmann-La Roche

Phase:

Ib/II

Protocol Number:

BH39147

Trial Registration Number:

NCT03135262

Clinical Trials.gov

ANZ Clinical Trial Registry