Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
The subject is invited to take part in this research study because s/he has been diagnosed
with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or
Post-transplant Lymphoproliferative Disorder (PTLD).
In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists
are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R,
utilizes two major new strategies. First, the treatment approach utilizes continuous infusion
of chemotherapy over four days, instead of being administered over minutes or hours.
Secondly, the doses of some medications involved are increased or decreased based on how the
drugs affect the subject's ability to produce blood cells, which is used as a measure of how
rapidly the body is processing drugs.
Using this approach in adults, researchers have shown improved cure rates in these cancers.
Additionally, the harmful effects experienced by patients has been mild, with mucositis,
severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method
has never been used in children, and the effectiveness and side effects of this new method
are unknown in children.
The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment
of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been
shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
Phase:
Early Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
National Cancer Institute (NCI) Texas Children's Hospital