A RANDOMIZED PHASE II STUDY OF RITUXIMAB WITH ABVD VERSUS STANDARD ABVD FOR PATIENTS WITH ADVANCED-STAGE CLASSICAL HODGKIN LYMPHOMA WITH POOR RISK FEATURES (IPS SCORE > 2)
The goal of this clinical research study is to compare the effectiveness of receiving Adriamycin (doxorubicin hydrochloride), bleomycin, vinblastine, and dacarbazine (ABVD) therapy alone to receiving ABVD with rituximab.
Disease Group: Lymphoma
Treatment Agent: Adriamycin
Treatment Location: Both at MD Anderson & outside MD Anderson at one or more Collaborating Sites or Institutions
Estimatated Length of Stay in Houston: N/A
Return Visit: Every 2 weeks for chemotherapy for 6 months. After treatment ends, patients will return for follow-up every 3 months for 1st year, every 4 months for 2nd year, every 6 months for Years 3-5, and annually thereafter.
Home Care: N/A
Primary: To evaluate the event free survival (EFS) following therapy with rituximab plus ABVD or standard ABVD in patients with newly diagnosed classical Hodgkin lymphoma who have poor prognosis defined as International prognostic score (IPS) of > 2. Secondary: 1. To compare the effect of the two treatment arms on PET scan results after 2 cycles of therapy. 2. To compare the effect of the two treatment arms on the level of circulating malignant Hodgkin stem cells.
IRB Review and Approval Date: 11/13/2007
Recruitment Status: Closed
Projected Accrual: 120
1) Previously untreated patient with classical Hodgkin's lymphoma
patients with stage III and IV.
2) International Prognostic Score of > 2 (patient must have > 2 of the following risk features: Male, >/= 45 years of age, Stage IV, Albumin <4, WBC >/= 15, Lymphocytes <8% or <600, Hgb <10.5).
3) Must sign a consent form.
4) Must be older than 16 years.
5) Must have adequate bone marrow reserve (ANC >/= 1,500/microL, Platelet > 100,000/microL).
6) LVEF >/= 50% by MUGA scan or echocardiogram.
7) Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl, AST or ALT < 2 x ULN.
8) Bi-dimensionally measurable disease.
1) Lymphocyte Predominant Hodgkin’s Lymphoma.
2) Known HIV infection.
3) Pregnant women and women of child bearing age who are not practicing adequate contraception.
4) Prior chemotherapy or radiation therapy.
5) Severe pulmonary disease as judged by the PI including COPD and asthma.
6) Active infection requiring treatment with intravenous therapy.
7) Presence of CNS lymphoma.
8) 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).
9) Active hepatitis B or C infection.