The goal of this clinical research study is to learn if intensive chemotherapy given over 6
months can help to control or cure Burkitt's leukemia, Burkitt's lymphoma, or small
non-cleaved cell B-cell leukemia or lymphoma. Another goal is to see how well this treatment
works when given with Rituximab. The safety of the combined treatment will also be studied.
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 cluster of differentiation antigen 20
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
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 there.
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.
1. Burkitt's or Burkitt-like leukemia and/or lymphoma, either previously untreated,
previously treated (may be in CR or with active disease after 1-2 courses of
chemotherapy), or HIV-related.
2. All ages are eligible.
3. Zubrod performance status < 3 (ECOG Scale, Appendix A).
4. Adequate liver function (bilirubin < 3.0 mg/dL, unless considered due to tumor), and
renal function (creatinine < 3.0 mg/dL, unless considered due to tumor).
5. Signed informed consent.