Use of Dose Adjusted EPOCH-R in the Treatment of Childhood Mature B Cell Malignancies
The subject will need to have a variety of tests, exams, or procedures to find out if s/he
can be on the study.
The subject will also require placement of a catheter that stays in the vein for safe
administration of chemotherapy drugs.
During the study...
If all of the tests that have been done show that s/he can participate and s/he chooses to
participate, treatment cycles will begin.
For patients with Burkitt Lymphoma and B-ALL:
A cycle equals three weeks. The subject will have a minimum of 6 cycles of treatment. The
cancer drugs s/he will receive are etoposide, vincristine, doxorubicin, cyclophosphamide,
prednisone, and rituximab with each cycle. The amount of the drugs will be determined by the
subject's weight at first, and some of the drugs will be adjusted up or down for later
cycles.
After two cycles of treatment, the subject will have imaging scans to see how the cancer
responded to treatment. If the cancer responded partially or completely to treatment, s/he
will receive an additional four cycles of treatment that are dose-adjusted like before.
For subjects with DLBCL, PTLD, and PMBCL:
A cycle equals three weeks. The subject will have a minimum of 6 cycles of treatment,
possibly 8. The cancer drugs s/he will receive are etoposide, vincristine, doxorubicin,
cyclophosphamide, prednisone, and rituximab with each cycle. The amount of the drugs will be
determined by the subject's weight at first, and some of the drugs will be adjusted up or
down for later cycles.
Rituximab will be given on Day 1 prior to continuous infusion drugs.
After 4 cycles, the subject will have imaging scans again to see how the cancer responded
to treatment. If the cancer responds completely after 4 cycles, s/he will get 2 more cycles
(6 cycles total). If the cancer partially responds, s/he will get 4 more cycles (8 total
cycles).
For all subjects:
If the subject has cancer in the Central Nervous System, s/he will receive a drug called
methotrexate. If s/he does not have cancer in the CNS, s/he will get methotrexate to try to
prevent CNS cancer.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Measure and assess adverse events
Adverse event data will be collected to evaluate the safety and feasibility of dose-adjusted EPOCH-R in the treatment of children with mature B-cell malignancies.
1 year
Yes
Stephen Simko, MD
Principal Investigator
Baylor College of Medicine
United States: Food and Drug Administration
H-30759, DA-EPOCH-R
NCT01760226
January 2013
January 2026
Name | Location |
---|---|
Texas Children's Hospital | Houston, Texas |