Status:
COMPLETED
Combination Chemotherapy With or Without Rituximab in Treating Participants With Stage III-IV Classic Hodgkin Lymphoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Classic Hodgkin Lymphoma
Lugano Classification Stage III Hodgkin Lymphoma AJCC v8
Eligibility:
All Genders
17+ years
Phase:
PHASE2
Brief Summary
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 rituxi...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the event free survival (EFS) following therapy with rituximab plus adriamycin (doxorubicin hydrochloride), bleomycin, vinblastine, and dacarbazine (ABVD) or standa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 19 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2018
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00654732
Start Date
March 19 2008
End Date
September 5 2018
Last Update
February 28 2020
Active Locations (4)
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1
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
M D Anderson Cancer Center
Houston, Texas, United States, 77030