Combination Chemotherapy With or Without Rituximab in Treating Participants With Stage III-IV Classic Hodgkin Lymphoma

Completed · Phase 2

Conditions studied: Classic Hodgkin Lymphoma, Lugano Classification Stage III Hodgkin Lymphoma AJCC v8, Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8

In brief

This phase II trial studies how well combination chemotherapy with or without rituximab works in treating participants with stage III-IV classic Hodgkin lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab with combination chemotherapy may work better in treating participants with classic Hodgkin lymphoma.

Key facts

Study ID

NCT00654732

Run by

M.D. Anderson Cancer Center

People needed

58

Starts

2008-03-19

Expected to finish

2018-09-05

Last updated by the study team

2020-02-28

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously untreated patient with classical Hodgkin's lymphoma patients with stage III and IV
• International Prognostic Score of > 2 (patient must have > 2 of the following risk features: Male, >= 45 years of age, stage IV, albumin < 4, white blood cell count [WBC] >= 15, lymphocytes < 8% or < 600, hemoglobin [Hgb] < 10.5)
• Must sign a consent form
• Absolute neutrophil count (ANC) >= 1,500/microL
• Platelet > 100,000/microL
• Left ventricular ejection fraction (LVEF) >= 50% by multigated acquisition (MUGA) scan or echocardiogram
• Serum creatinine < 2 mg/dl
• Serum bilirubin < 2 mg/dl
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x upper limit of normal (ULN)
• Bi-dimensionally measurable disease

You may not qualify if…

• Lymphocyte predominant Hodgkin's lymphoma
• Known human immunodeficiency virus (HIV) infection
• Pregnant women and women of child bearing age who are not practicing adequate contraception
• Prior chemotherapy or radiation therapy
• Severe pulmonary disease as judged by the principal investigator (PI) including chronic obstructive pulmonary disease (COPD) and asthma
• Active infection requiring treatment with intravenous therapy
• Presence of central nervous system (CNS) lymphoma
• Concomitant malignancies or previous malignancies within the last 5 years (exception made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix)
• Active hepatitis B or C infection

Where it is running

• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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