This study is evaluating the effectiveness of EPOCH-R chemotherapy for patients with non-Hodgkin's lymphoma (NHL) who are HIV-positive. The main outcome to be measured will be survival without cancer growing or spreading. This study is recruiting in Bethesda, Maryland, United States.
The details
Patients with NHL who are HIV-positive have a weakened immune system. Chemotherapy can further weaken the immune system. Limiting the total amount of chemotherapy treatment may help treat lymphoma while decreasing the risk of infections and future cancers. This can be done using short-course EPOCH-R (etoposide, doxorubicin, vincristine, cyclophosphamide, rituximab) chemotherapy. This type of chemotherapy is given over a short period of time and is less intense than conventional chemotherapy.
This study is evaluating the effectiveness of EPOCH-R chemotherapy for patients with NHL who are HIV-positive. The main outcome to be measured will be progression-free survival (time from treatment until tumor growth or spread).
Who are they looking for?
This trial is recruiting 80 patients with NHL who are HIV-positive. Patients must have not had prior chemotherapy treatment for NHL. They must also have adequate organ (liver, bone marrow, and kidney) function tests.
Patients who had treatment with rituximab (Rituxan) before, those with active infections or severe diarrhea cannot participate. Patients with lymphoma in the brain, heart failure or heart disease cannot participate. Patients who are pregnant or breastfeeding cannot participate.
How will it work
This trial will involve one group of patients. All patients will receive 3 to 6 cycles of treatment. EPOCH chemotherapy will be given every 3 weeks (1 cycle). 2 doses of rituximab will be given per cycle. During each cycle, patients will also receive filgrastim (Neupogen). This is a type of growth factor that helps white blood cells recover after treatment.
The main outcome to be measured will be progression-free survival at follow-up. PET/CT scanning will be used to evaluate response to treatment after cycles 2 and 3. Blood tests will also be given. Patients will be followed-up at 2 months and every 3 to 6 months after treatment ends for a total of 2 years.
