Status:
COMPLETED
Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
OBJECTIVES:\> Primary\> * Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00301821
Start Date
January 1 2006
End Date
April 1 2015
Last Update
October 9 2019
Active Locations (162)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
3
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
4
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933