Lymphoma Clinical Trial

Combination Chemotherapy w w/o Auto Transplant for Central Nervous System B-Cell Lymphoma (CALGB 51101)
A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma

Clinical # NCT01511562

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient’s blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This randomized phase II trial studies how well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central nervous system B-cell lymphoma.
Eligibility Criteria (must meet the following to participate in this study)
•         Diagnosis of primary central nervous system (CNS) diffuse large B-cell lymphoma confirmed by one of the following:
o    Brain biopsy or resection<<
o    Cerebrospinal fluid<<
o    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)<
•         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<
•         No prior chemotherapy or radiation therapy for lymphoma<
•         No history of organ transplantation or ongoing immunosuppressant therapy<
•         No concurrent palliative radiotherapy<
Investigator: Maciej M. Mrugala, MD
Research Coordinator: Alisa Claeys. Phone 206-616-4925
University of Washington Medical Center, Seattle, WA 98195
Seattle Cancer Care Alliance, Seattle, WA 98109