A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.
OBJECTIVES:> Primary>
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell lymphoma
CD22+ tumor by IHC*
NOTE: *CD22 status may be determined after study enrollment
Measurable disease, defined as at least 1 lesion ≥ 1.5 cm by CT scan or physical exam
No relapsed or refractory non-Hodgkin's lymphoma
No history of transformed lymphoma
No CNS lymphoma
PATIENT CHARACTERISTICS:
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
- For patients with ECOG PS 3, the PS must be disease related
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Total bilirubin ≤ 2 mg/dL (if total bilirubin > 2 mg/dL, direct bilirubin should be within normal limits)
AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if there is liver involvement)
Creatinine ≤ 2 times ULN
Life expectancy ≥ 12 weeks
Negative pregnancy test
Not pregnant or nursing
Fertile patients must use effective contraception during and for 12 months after completion of study treatment
No active serious infection requiring antibiotics
No New York Heart Association class III or IV heart disease
No other primary malignancy within the past 5 years, except for squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or previously treated prostate cancer with a stable prostate-specific antigen
No known HIV positivity
No known hepatitis B or C infection
Ejection fraction ≥ 45% by MUGA or echocardiogram (required if patients has a history of heart disease or is ≥ 50 years old)
Willing to provide blood and tissue samples for mandatory translational research component of study
PRIOR CONCURRENT THERAPY:
No prior therapy for diffuse large B-cell lymphoma, including the following:
Prior short course (≤ 14 days) of corticosteroids allowed
Prior splenectomy allowed
No prior pelvic irradiation
No other concurrent investigational agents
No concurrent chemotherapy, immunotherapy, or radiotherapy
No concurrent enrollment on another treatment study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy)
Grand Junction, Colorado 81502, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Beech Grove, Indiana 46107, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Wichita, Kansas 67214, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Allentown, Pennsylvania 18105, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States
Fredericksburg, Virginia 22401, United States