Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma

Status: Recruiting
Phase: Phase 2
Diagnosis: Brain/Neuro Cancer: Newly Diagnosed
NCT ID: NCT01511562 (View complete trial on
DFCI Protocol ID: 12-440


The purpose of this study is to find out what effects (good and/or bad) treatment with chemotherapy and stem cell transplant compared with chemotherapy alone will have on primary CNS B-cell lymphoma. Currently the best treatment for patients with primary CNS B-cell lymphoma is not known.


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Tracy Batchelor, MD, Massachusetts General Hospital

Site-responsible Investigators:
Lakshmi Nayak M.D., Dana Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Lisa Doherty,

Eligibility Criteria

DISEASE CHARACTERISTICS: - Diagnosis of primary central nervous system (CNS) diffuse large B-cell lymphoma confirmed by one of the following: - Brain biopsy or resection - Cerebrospinal fluid - Vitreous fluid - No evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS - No isolated ocular lymphoma or isolated leptomeningeal lymphoma - At least one measurable, contrast-enhancing brain lesion (≥ 1 cm in length) PATIENT CHARACTERISTICS: - Karnofsky performance status ≥ 30% (≥ 50% for patients ages 60-70 years) - Adequate cardiac function (left ventricular ejection fraction [LVEF] ≥ 50%) and pulmonary function (corrected diffusion capacity of carbon monoxide [DLCO] ≥ 60% predicted) - Pregnant or nursing patients may not be enrolled; women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom) - Negative human immunodeficiency virus (HIV) serology - Negative hepatitis B virus (HBV) and hepatitis C virus (HCV) serology (unless HBV antibody [HBsAb]-positive patient has recently received HBV vaccine, in this case HBcAb should be negative) - Absolute neutrophil count (ANC) ≥ 1500/mcL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 times upper limit of normal (ULN) - Total bilirubin ≤ 3 mg/dL - Creatinine clearance ≥ 50 mL/min - Platelet count ≥ 100,000/mcL PRIOR CONCURRENT THERAPY: - No prior chemotherapy or radiation therapy for lymphoma - No history of organ transplantation or ongoing immunosuppressant therapy - No concurrent palliative radiotherapy
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