Phase 1/Expansion Study of Tazemetostat Plus Belinostat for the Treatment of Relapsed or Refractory Lymphoma

Contact:

NCT Number:

Protocol:

AAAT9882

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of drugs called tazemetostat and belinostat when administered together. This study tests different doses of the drugs to see which doses are safer for people. There will be between 21 and 48 people taking part in this study. There are two parts in this study, a dose escalation (dose finding) part and a dose expansion part (where the established dose is tested further). In the dose escalation part of this study, different people will get different doses of the study drugs tazemetostat and belinostat. The first 3 people taking part in this study will get the lowest dose. If the drugs do not cause serious side effects, the next group of people in the study will get a higher dose. The study doctor will watch each group carefully as they increase the dose. The doses will continue to increase for every new group until people have serious side effects that require the dose to be lower. Once this dose is found, the dose escalation is stopped. In the dose expansion part of this study, the highest doses of the study drugs with manageable side effects will be given to 12 more people. This will help study doctors better understand the side effects that may happen with this drug combination.

Are you Eligible? (Inclusion Criteria)

  • Are you 18 years of age or older? Have you been diagnosed with lymphoma that has either returned or not improved after treatment? Are you able to make regularly scheduled visits to the clinic for treatment and examinations?

Specialty Area(s)

Lymphoma, Non-Hodgkin's Lymphoma

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032