Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Mar 9, 2006

Keywords

ClinConnect Summary

OBJECTIVES:\> Primary\>

* Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma.\>
* Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.\>
* Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this reg...

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ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically confirmed diffuse large B-cell lymphoma
• • B-cell phenotype (CD20+) as determined by immunohistochemistry (IHC) or flow cytometry
• • Stage II, III, or IV disease
• • 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
• • CNS symptoms or bone marrow or sinus involvement must have absence of CNS lymphoma confirmed by lumbar puncture
• 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:
• • Chemotherapy
• • Immunotherapy
• • Biologic therapy
• • Radiotherapy
• • 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)