Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma
Stopped early · Phase 2
Conditions studied: Burkitt Lymphoma, Non-Hodgkins Lymphoma, Atypical Burkitt Lymphoma
In brief
The purpose of this study is to learn more about how well a chemotherapy regime including rituximab works in treating patients with Burkitt or atypical Burkitt lymphoma.
Key facts
- Study ID
- NCT00126191
- Run by
- Dana-Farber Cancer Institute
- People needed
- 10
- Starts
- 2005-07-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2013-05-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically documented Burkitt or atypical Burkitt according to World Health Organization (WHO) criteria.
- Pathology must be reviewed at the Brigham and Women's Hospital (BWH).
- Measurable or evaluable disease: Disease reproducibly measurable in two perpendicular dimensions on exam, computed tomography (CT), radiograph, or magnetic resonance imaging (MRI). Disease present on bone marrow biopsy will be considered as evaluable disease.
- The following may not be used as the sole site of measurable or evaluable disease: *ascites, *pleural effusion, *bone lesion or *central nervous system (CNS) disease.
- Age > 18
- Laboratory data (within 2 weeks of study registration):
- ANC > 1500/ul;
- platelet > 100,000/ul;
- creatinine < 1.5 X normal;
- creatinine clearance > 60 ml/min;
- bilirubin < 1.5 X normal;
- AST and ALT < 2.5 X normal;
- alkaline phosphates < 3 X normal;
- HIV negative;
- cardiac ejection fraction > 50%.
You may not qualify if…
- Previous chemotherapy or radiation therapy. Steroids of less than 72 hours duration for impending oncologic emergency are allowed.
- Uncontrolled bacterial, fungal, or viral infection.
- Concomitant malignancy excluding carcinoma in situ of the cervix and basal cell carcinoma of the skin.
- Serious comorbid disease. Clinically significant pulmonary symptomatology. In patients with a history of symptomatic pulmonary disease, pulmonary function tests (PFTs) should document an forced expiratory volume at 1 second (FeV1), forced vital capacity (FVC), and total lung capacity (TLC) of > 60% predicted and carbon monoxide diffusing capacity of the lung (DLCO) of > 50% predicted. No clinically significant cardiac symptomatology. The cardiac ejection fraction must be > 50%.
- Pregnancy. All males and females with reproductive potential must consent to use an effective form of contraception while on study.
- Major surgery within the previous 2 weeks.
Where it is running
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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