Non Hodgkin Lymphoma Clinical Trial
Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
The investigator(s) hypothesize that Rituximab together with combination chemotherapy, followed by Rituximab maintenance therapy, will provide better disease control with improved response rates and overall survival in patients with previously untreated Mantle Cell Lymphoma (MCL).
Previously untreated, histologically confirmed mantle cell lymphoma,
Measurable or evaluable disease (at least one site with >1.5 cm in diameter
All stages are eligible
Age > 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Adequate hepatic function:
Bilirubin < 3 mg/dL
Transaminases (serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate-pyruvate transaminase (SGPT)) < than 2.5 times the upper limit of normal for the institution, unless due to lymphomatous involvement
Serum creatinine< 1.5 mg/dl
Ability to give informed consent
Women of childbearing potential must have a negative pregnancy test within 72 hours of entering into the study. Males and females must agree to use adequate birth control if conception is possible during the study. Women must avoid pregnancy and men avoid fathering children while in the study.
Life expectancy greater than 6 months.
Previous chemotherapy, immunotherapy or radiotherapy for this mantle cell lymphoma
Concurrent active malignancies, with the exception of in situ carcinoma of the cervix and basal cell carcinoma of the skin.
Grade 3 or 4 cardiac failure and/or ejection fraction < 50.
Psychological, familial, sociological or geographical conditions that do not permit treatment and/or medical follow-up required to comply with the study protocol.
Patients with a known history of human immunodeficiency virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS).
Presence of hepatitis or hepatitis B virus (HBV) infection.
Pregnant or breast-feeding women.
Central Nervous System (CNS) involvement.
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There is 1 Location for this study
Miami Florida, 33186, United States
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