A Phase I Trial of BBR 2778 in Combination With Fludarabine, Dexamethasone and Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
The FND-R regimen is commonly used in the treatment of indolent Non-Hodgkin's lymphoma (NHL)
and contains the chemotherapy agents mitoxantrone, fludarabine, dexamethasone (a steroid)
and the monoclonal antibody rituximab. In this trial we are replacing mitoxantrone with
pixantrone, an agent with a similar chemical structure (both agents are DNA intercalators).
The trial is being run in patients with relapsed or refractory indolent NHL and aims to
define the appropriate dose of pixantrone to be used in this combination, as well as to
obtain data on pixantrone's safety and activity profile in combination with these drugs.
This trial is expected to recruit up to 30 patients in the USA. Patients will be treated
with the drug combination for up to eight months and then followed closely in the four-week
period after the last administration. After that, patients will receive physician check-ups
every three months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Scott Stromatt, MD
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Greater Baltimore Medical Center||Baltimore, Maryland 21204|
|Arizona Clinical Research Center||Tucson, Arizona 85712|
|New Mexico Onc/Hem Consultants, Inc.||Albuquerque, New Mexico 87109|