Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia
Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy, such as pentostatin, cyclophosphamide, and CAMPATH-1H work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well pentostatin, cyclophosphamide, rituximab, and CAMPATH-1H work in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia.
OBJECTIVES:
Primary
Secondary
Exploratory
Inclusion criteria:
Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria:
Peripheral blood absolute lymphocyte count greater than 5,000/mm^3
Lymphocytosis must comprise small to moderate size lymphocytes with no greater than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
Phenotypically characterized CLL defined by the following:
Requires chemotherapy, as indicated by any of the following:
Disease-related symptoms
Evidence of progressive marrow failure manifested by the development of or worsening anemia (hemoglobin no greater than 10 g/dL) and/or thrombocytopenia (platelet count no greater than 100,000/mm^3)
Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly
Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy
Progressive lymphocytosis with an increase of greater than 50% over a 2-month period OR an anticipated doubling time of less than 6 months
Demonstrated progression after at least 1 course of either an alkylating agent-based or purine nucleoside-based (e.g., fludarabine) regimen OR failed to achieve a meaningful response OR relapsed after prior therapy
18 and over
ECOG Performance Status 0-2
Bilirubin no greater than 2 mg/dL (unless secondary to tumor, hemolysis, or Gilbert syndrome)
Creatinine no greater than 2.0 mg/dL
Creatinine clearance ≥ 30 mL/min
Negative pregnancy test
Fertile patients must use 2 methods of effective contraception (including 1 barrier method) for at least 28 days before starting lenalidomide, while participating in the study, and for at least 28 days after discontinuation/stopping lenalidomide
At least 8 weeks since prior rituximab
At least 6 weeks since prior chemotherapy
At least 1 year since prior pentostatin, cyclophosphamide, and rituximab (PCR) therapy
Exclusion criteria:
Hartford, Connecticut 06105, United States
Lakeland, Florida 33805, United States
Boise, Idaho 83706, United States
Chicago, Illinois 60611-3013, United States
Libertyville, Illinois 60048, United States
Moline, Illinois 61265, United States
La Porte, Indiana 46350, United States
Wichita, Kansas 67214, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Voorhees Township, New Jersey 08043, United States
Hershey, Pennsylvania 17033-0850, United States
Reading, Pennsylvania 19612-6052, United States
Wilkes-Barre, Pennsylvania 18711, United States
Sioux Falls, South Dakota 57117-5039, United States
Manitowoc, Wisconsin 54221-1450, United States