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

Alternate Title

Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Not specified	NCI	CALGB-50103 NCT00032019

Objectives

1. Determine the response rate, progression-free survival, and overall survival of patients with previously untreated aggressive CD20+ B-cell diffuse large cell or immunoblastic large cell lymphoma treated with rituximab, doxorubicin, etoposide, vincristine, prednisone, and cyclophosphamide.
2. Determine the toxic effects of this regimen in these patients.
3. Correlate tumor proliferation rate (MIB-1), bcl-2 expression, and p53 overexpression with complete response rate, progression-free survival, and overall survival in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage II, III, or IV diffuse large cell lymphoma and WHO variants
  • CD20+ large B-cell lymphoma, including those with immunoblastic features
  • CD20+ thymic B-cell lymphoma
  • No evidence of indolent lymphoma
  • No mantle cell lymphomas or equivocal B-cell lymphomas that express markers of mantle cell lymphoma (e.g., cyclin D) or other subtypes



• No known lymphomatous involvement of the CNS, including the parenchyma or leptomeninges

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior cytotoxic chemotherapy
• No other concurrent chemotherapy

Endocrine therapy:

• Prior short-course of glucocorticoids allowed
• No concurrent hormones except for non-disease-related conditions (e.g., insulin for diabetes)
• No concurrent steroids except for adrenal failure
• No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy:

• Prior limited-field radiotherapy allowed

Surgery:

• Not specified

Patient Characteristics:

Age:

• Not specified

Performance status:

• CALGB 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm3*
• Platelet count at least 100,000/mm3*

 [Note: * Unless due to lymphoma]

Hepatic:

• Bilirubin no greater than 2.0 mg/dL*

 [Note: * Unless due to lymphoma or Gilbert's disease]

Renal:

• Creatinine no greater than 1.5 mg/dL*

 [Note: * Unless due to lymphoma]

Cardiovascular:

• LVEF greater than 45%
• No ischemic heart disease
• No myocardial infarction or congestive heart failure within the past year

Other:

• HIV negative
• Not pregnant or nursing
• Fertile patients must use effective contraception

Expected Enrollment

A total of 25-50 patients will be accrued for this study within 1 year.

Outline

This is a multicenter study.

Patients receive rituximab IV on day 1; doxorubicin IV continuously, etoposide IV continuously, and vincristine IV continuously on days 1-4; oral prednisone twice daily on days 1-5; and cyclophosphamide IV on day 5. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients with complete or partial response receive 2 additional courses.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Hsi ED, Said J, Johnson JL, et al.: Biologic prognostic markers in diffuse large B-cell lymphoma patients treated with dose adjusted EPOCH-R: a CALGB 50103 correlative science study. [Abstract] Blood 112 (11): A-476, 2008.

Wilson WH, Porcu P, Hurd D, et al.: Phase II study of dose-adjusted EPOCH-R in untreated de novo CD20+ diffuse large B-cell lymphoma (DLBCL)-CALGB 50103. [Abstract] J Clin Oncol 23 (Suppl 16): A-6530, 567s, 2005.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Wyndham Wilson, MD, PhD, Protocol chair		Ph: 301-435-2415

Registry Information
Official Title		Phase II Study Of Dose-Adjusted Epoch-Rituximab (EPOCH-R) Chemotherapy For Patients With Previously Untreated Aggressive CD20+ B-Cell Non-Hodgkin's Lymphoma (NHL)
Trial Start Date		2002-02-15
Registered in ClinicalTrials.gov		NCT00032019
Date Submitted to PDQ		2002-01-25
Information Last Verified		2004-07-22
NCI Grant/Contract Number		CA31946

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