Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	NCCTG-N0489 N0489, NCT00301821

Objectives

Primary

1. 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.
2. Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.
3. Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen.
4. Assess the safety of this treatment regimen.

Secondary

1. Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen.

Entry 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

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)

Patient Characteristics:

• ECOG performance status (PS) 0-3
  • For patients with ECOG PS 3, the PS must be disease related
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

A total of 86 patients will be accrued for this study.

Outcomes

Response rate as assessed by complete response (CR) and partial response (PR) rates at end of treatment
Event-free survival after 12 months
Overall survival after 12 months

Toxicity as assessed by incidence of neutropenia during each course of treatment

Outline

This is a multicenter study.

Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

Micallef IN, Maurer MJ, Nikcevich DA, et al.: Final results of NCCTG N0489: epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (ER-CHOP) in patients with previously untreated diffuse large B-cell lymphoma. [Abstract] J Clin Oncol 27 (Suppl 15): A-8508, 2009.

Micallef IN, Kahl BS, Maurer MJ, et al.: A pilot study of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated, diffuse large B-cell lymphoma. Cancer 107 (12): 2826-32, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Ivana Micallef, MD, Protocol chair		Ph: 507-538-7623
Daniel Nikcevich, MD, PhD, Protocol co-chair		Ph: 218-786-3625; 888-203-7267 Email: dnikcevich@smdc.org
Thomas Witzig, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
Trial Start Date		2006-01-20
Registered in ClinicalTrials.gov		NCT00301821
Date Submitted to PDQ		2005-11-15
Information Last Verified		2007-08-13
NCI Grant/Contract Number		CA25224

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