Chronic Lymphocytic Leukemia Clinical Trial
Pentostatin, Cyclophosphamide, and Rituximab Followed By Campath-1H in Patients With Relapsed or Refractory B-Cell CLL
Summary
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 leukemia-cll/" >chronic lymphocytic leukemia.
Full Description
OBJECTIVES:
Primary
Determine the objective response rate (complete remission, partial remission [PR], or nodular PR) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL) treated with pentostatin, cyclophosphamide, and rituximab (PCR) followed by CAMPATH-1H .
Determine the presence of minimal residual disease in patients treated with this regimen who achieve a CR or nPR
Secondary
Determine the toxicity of this regimen in these patients.
Determine the overall and progression-free survival of patients treated with this regimen.
Evaluate the number of patients who after PCR (or during PCR for PD), only achieve a PR, SD, or PD and who subsequently convert to a higher response category after CAMPATH-1H .
Exploratory
Assess the angiogenic profile (i.e., secretion levels of pro- versus anti-angiogenic molecules) of CLL B cell clones as well as bone marrow angiogenesis (i.e., vascular density by immunohistochemistry) at baseline, after PCR, after CAMPATH-1H, every six months (serum only), and at time of response assessment (marrow).
Determine the V_H gene mutation status and CD38 expression of the B-CLL clones at study entry and at the end of the therapy and assess the association between the VH gene mutation status and CD38 expression and clinical outcome.
Determine surface phenotype (by flow cytometry) and genetic defects (by CLL FISH panel) information on CLL-B cell clones and associate with clinical outcome.
Monitor the T-cell status by repertoire and flow cytometry analysis to determine the nature and extent of T-cell deficiency induced by the PCR and CAMPATH-1H treatment and assess any association with clinical outcome and toxicities.
Eligibility Criteria
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:
Predominant population of cells share B-cell antigens with CD5 in the absence of other pan-T-cell markers (CD3 or CD2)
B cell expresses either kappa or lambda light chains
Surface immunoglobulin with low cell surface density expression
Requires chemotherapy, as indicated by any of the following:
Disease-related symptoms
Weight loss of 10% or more within the past 6 months
Extreme fatigue
Fevers greater than 100.5°F for 2 weeks without evidence of infection
Night sweats without evidence of infection
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
Patients who have relapsed after a pentostatin-based regimen are eligible provided the response was greater than 12 months prior to study entry
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
PCR therapy at least 1 year prior to study entry allowed
Exclusion criteria:
Bone marrow dysplasia related to prior therapy
New York Heart Association class III or IV heart failure
Prior lenalidomide
Other malignancy within the past 2 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
Pregnant or nursing
Concurrent oral or IV antibiotics for active infection
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There are 127 Locations for this study
Scottsdale Arizona, 85259, United States
Aurora Colorado, 80012, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80933, United States
Denver Colorado, 80204, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80220, United States
Denver Colorado, 80222, United States
Englewood Colorado, 80110, United States
Greeley Colorado, 80631, United States
Littleton Colorado, 80122, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80501, United States
Loveland Colorado, 80539, United States
Pueblo Colorado, 81004, United States
Thornton Colorado, 80229, United States
Wheat Ridge Colorado, 80033, United States
Hartford Connecticut, 06105, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Jacksonville Florida, 32207, United States
Lakeland Florida, 33805, United States
Boise Idaho, 83706, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Decatur Illinois, 62526, United States
Highland Park Illinois, 60035, United States
Hinsdale Illinois, 60521, United States
Kankakee Illinois, 60901, United States
Libertyville Illinois, 60048, United States
Moline Illinois, 61265, United States
Niles Illinois, 60714, United States
Rockford Illinois, 61104, United States
Skokie Illinois, 60076, United States
Elkhart Indiana, 46515, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Mishawaka Indiana, 46545, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51102, United States
Sioux City Iowa, 51104, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Fort Scott Kansas, 66701, United States
Independence Kansas, 67301, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Baton Rouge Louisiana, 70809, United States
Covington Louisiana, 70433, United States
New Orleans Louisiana, 70115, United States
New Orleans Louisiana, 70121, United States
Elkton Maryland, 21921, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48123, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grosse Pointe Woods Michigan, 48236, United States
Jackson Michigan, 49201, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Saginaw Michigan, 48601, United States
Saint Joseph Michigan, 49085, United States
Saint Joseph Michigan, 49085, United States
Warren Michigan, 48093, United States
Bemidji Minnesota, 56601, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
New Ulm Minnesota, 56073, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
East Orange New Jersey, 07018, United States
Voorhees New Jersey, 08043, United States
New York New York, 10003, United States
Fargo North Dakota, 58122, United States
Fargo North Dakota, 58122, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Lima Ohio, 45801, United States
Danville Pennsylvania, 17822, United States
Hazleton Pennsylvania, 18201, United States
Hershey Pennsylvania, 17033, United States
Lewistown Pennsylvania, 17044, United States
Reading Pennsylvania, 19612, United States
State College Pennsylvania, 16801, United States
State College Pennsylvania, 16803, United States
Wilkes-Barre Pennsylvania, 18711, United States
Sioux Falls South Dakota, 57117, United States
Chippewa Falls Wisconsin, 54729, United States
Eau Claire Wisconsin, 54701, United States
Green Bay Wisconsin, 54307, United States
Manitowoc Wisconsin, 54221, United States
Marinette Wisconsin, 54143, United States
Marshfield Wisconsin, 54449, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53226, United States
Minocqua Wisconsin, 54548, United States
Rhinelander Wisconsin, 54501, United States
Rice Lake Wisconsin, 54868, United States
Sheboygan Wisconsin, 53081, United States
Stevens Point Wisconsin, 54481, United States
Stevens Point Wisconsin, 54481, United States
Wausau Wisconsin, 54401, United States
Weston Wisconsin, 54476, United States
Weston Wisconsin, 54476, United States
Wisconsin Rapids Wisconsin, 54494, United States
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