This clinical trial studies combination chemotherapy with or without radiation therapy in treating patients with newly diagnosed low or intermediate-risk Hodgkin lymphoma. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, cyclophosphamide, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving combination chemotherapy with radiation therapy may kill more cancer cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01858922.
PRIMARY OBJECTIVES:
I. To define the general immune recovery and the behavior of antigen-specific cytotoxic T-cells in patients with low and intermediate risk Hodgkin's disease (HD) undergoing chemotherapy with or without radiation therapy as specified in this protocol.
II. To identify tumor and circulating biomarkers in patients with low and intermediate risk HD who receive chemotherapy with or without radiation therapy as specified in this protocol and correlate with clinical outcomes including incidence of relapse and infection.
OUTLINE:
DOXORUBICIN HYDROCHLORIDE, BLEOMYCIN SULFATE, VINCRISTINE SULFATE, ETOPOSIDE, CYCLOPHOSPHAMIDE (ABVE-PC): Patients receive doxorubicin hydrochloride intravenously (IV) over 10 minutes on days 1 and 2, bleomycin IV over 10 minutes and vincristine sulfate IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone orally (PO) twice daily (BID) on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses. Patients achieving rapid early response (RER) receive 2 additional courses of ABVE-PC; patients achieving slow early response (SER) receive 2 courses of dexamethasone, etoposide, cytarabine, cisplatin (DECA) followed by 2 additional courses of ABVE-PC.
DECA: Patients receive dexamethasone IV over 15 minutes or intramuscularly (IM), etoposide IV over 3 hours, and cytarabine IV concurrently over 3 hours on days 1 and 2. Patients also receive cisplatin IV over 6 hours on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) or partial response (PR) proceed to course 3 of ABVE-PC.
INVOLVED FIELD RADIATION THERAPY (IFRT): Beginning within 6 weeks of the start of the last course of chemotherapy, patients achieving RER with PR after course 4 of ABVE-PE and all patients achieving SER undergo IFRT according to institutional standard of care.
After completion of study treatment, patients are followed up at 3, 6, 12, and 18 months and then periodically for up to 4 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorCarl E. Allen
