Use of Dose Adjusted EPOCH-R in the Treatment of Childhood Mature B Cell Malignancies (DA-EPOCH-R)

NCT01760226 EARLY_PHASE1 COMPLETED

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.

Details

Lead sponsor	Baylor College of Medicine
Phase	EARLY_PHASE1
Status	COMPLETED
Enrolment	4
Start date	2013-01
Completion	2016-12

Conditions

• Diffuse Large B Cell Lymphoma
• Post Transplant Lymphoproliferative Disorder
• Primary Mediastinal (Thymic) Large B-cell Lymphoma

Interventions

• DA-EPOCH-R for DLBCL, PTLD, AND PMBCL
• Methotrexate
• Etoposide
• Doxorubicin
• Vincristine
• Rituximab
• Cyclophosphamide
• Prednisone
• G-CSF

Primary outcomes

• Measure and assess adverse events — 1 year
  To evaluate the safety and feasibility of dose-adjusted EPOCH-R in the treatment of use in children and young adults with mature B-cell malignancies, including, DLBCL, and PMBCL, as well as in patients with post-transplant lymphoproliferative disorder (PTLD).

Countries

United States