drugset / Trial / NCT01858922

Chemotherapy With or Without Radiation, Low and Intermediate Risk Hodgkins Lymphoma, TXCH-HD-12A

NCT01858922

Phase 2 Completed 40 enrolled Baylor College of Medicine
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Subjects have a type of cancer called Hodgkin Disease (HD), a cancer of the lymph system. The lymph system is made up of tissue throughout the body that makes and stores infection-fighting cells. HD is one of the most treatable childhood cancers. The standard treatment for HD involves chemotherapy (treatment with anti-cancer drugs) and radiation therapy (the use of high-dose x-rays to get rid of cancer cells). Although they are cured from their cancer, some patients experience negative side effects from treatment later in life. These kinds of side effects are often referred to as late effects. This can include problems with growth, problems with some organ functions, and sometimes second cancers. These types of effects can be associated with either chemotherapy or radiation therapy. The investigators are therefore designing studies to minimize or prevent these late effects. It is thought that if some patients can be successfully treated without radiation, those patients might experience fewer late side effects. Some patients, however, do not respond as well to the first stages of treatment (slow early responders). Slow early responders are considered to be at higher risk for relapse. This study also looks at whether these kinds of patients will benefit from additional chemotherapy. The purpose of this study is to look at how the immune system recovers and at how certain T-cells in the blood behave after receiving chemotherapy with or without radiation. The investigators also want to identify if bio-markers (special proteins in blood and in cancer) relate to the response of HD to study treatment.

Timeline

Start
2012-12-19
Primary completion
2019-08-12
Completion
2019-08-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bleomycin Unknown 10 unknown Intravenous
Subject Cisplatin Other / unclassified 90 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 800 mg/m2 Intravenous
Subject Cytarabine Small molecule 3000 mg/m2 Intravenous
Subject Dexamethasone Small molecule 2 unknown Intravenous
Subject Dexamethasone Small molecule 10 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 25 mg/m2 Intravenous
Subject Etoposide Small molecule 100 mg/m2 Intravenous
Subject Etoposide Small molecule 125 mg/m2 Intravenous
Subject Prednisone Other / unclassified 40 mg/m2 Oral
Subject Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications