Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma
The hyper-CVAD regimen is a combination of chemotherapy drugs including cyclophosphamide,
vincristine, Adriamycin, and dexamethasone given together to for one "course" of treatment.
This alternates with a course or combination of the chemotherapy drugs methotrexate and
cytarabine. Rituximab is a protein (monoclonal antibody) that attaches to the surface of
the leukemia or lymphoma cells which have a marker called "CD20".
During treatment, participants will have a physical exam and give blood samples (about 1
tablespoon each) at least twice a week. After two courses of chemotherapy, the tests done
before treatment will be repeated to check for response. In patients with leukemia, a bone
marrow sample will be repeated 2 and 3 weeks from the beginning of treatment to check the
All participants in this study will receive 2 kinds of chemotherapy courses for a total of 8
courses. Chemotherapy courses will be given through a large vein by a central venous
catheter (a plastic tube usually placed under the collarbone).
In Course 1 (odd course), participants will receive rituximab by vein over 6 hours on Days 1
and 11. Participants will receive the drugs acetaminophen (Tylenol) and diphenhydramine
hydrochloride (Benadryl) 30-60 minutes before each dose of rituximab. This will be done to
lessen the risk of fever, chills, and allergic reactions. Usually, the first dose of
rituximab requires about 6 hours to complete.
Participants will then receive cyclophosphamide by vein over 2-3 hours every 12 hours for a
total of 6 doses, given over 3 days (Days 1, 2, and 3). Adriamycin will be given by vein
over 24 hours on Day 4. Vincristine will be given by vein over 15 to 30 minutes on Days 4
and 11 along with dexamethasone by mouth or by vein on Days 1-4 and 11-14.
Participants will also receive pegfilgrastim or G-CSF (growth stimulating colony factor) to
help with rapid recovery of the normal bone marrow starting after each course of
chemotherapy is finished. Pegfilgrastim is injected under the skin within 72 hours of
completion of each cycle of chemotherapy. G-CSF is given by injections by vein or under the
skin until the blood counts recover.
Treatment to the brain will be given inside the spinal fluid with cytarabine and
methotrexate about Days 2 and 7 of the course to help prevent the leukemia from developing
For patients 60 years or older, the first course will be given in a protective isolation
room to decrease the risk of infection(s).
In Course 2 (even course), participants will receive rituximab by infusion over about 4
hours on Days 1 and 8. They will receive methotrexate by infusion over 24 hours on the
first day, and cytarabine in a high dose over 2 hours every 12 hours for 4 doses (Days 2 and
3). Citrovorum factor (leucovorin) will be given by vein or by mouth for 2-3 days (Day 2
and on) to decrease the risk of side effects of methotrexate. G-CSF will be given as in
Course 1 (after the chemotherapy is finished). The treatment to the brain inside the spinal
fluid will be given as in course 1 on days 2 and 7.
After two courses of therapy, the response to the treatment will be checked. If the
leukemia or lymphoma is responding, the therapy will be continued for a total of 8 courses
over 6 months. Therapy will be stopped if the leukemia or lymphoma starts to get worse.
An Ommaya reservoir may also be placed surgically as a route to treat leukemia in the brain
or to decrease the risk of leukemia in patients who have difficulty with the spinal
treatments. An Ommaya reservoir is a tube inserted under the skin of the scalp that enters
into the spinal fluid cavity of the brain.
This is an investigational study. All drugs in this study are commercially available. Their
use together in this study is investigational. About 70 patients or more will take part in
this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Complete Remission (CR) + Disease-Free Survival
After two courses of therapy, response to treatment checked for: 1) Complete Remission (CR) or 2) Disease-free survival (time from documented CR until relapse or death).
After two 21-day courses
Susan O'Brien, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|The University of Texas M. D. Anderson Cancer Center||Houston, Texas 77030|