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Phase II Trial of EPOCH and Rituxan Combined Therapy in Patients With Refractory or Relapsed CD20 Positive Intermediate Grade B-Cell Non-Hodgkin's Lymphoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Phase II Trial of EPOCH and Rituxan Combined Therapy in Patients With Refractory or Relapsed CD20 Positive Intermediate Grade B-Cell Non-Hodgkin's Lymphoma

OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent CD20+
intermediate grade B-cell non-Hodgkin's lymphoma treated with rituximab followed by
etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone (EPOCH). II. Determine
the toxicity of the regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive rituximab IV over 4-10 hours on day 1
followed by etoposide, vincristine, and doxorubicin IV continuously on days 4-7,
cyclophosphamide IV over 5-30 minutes on day 8 and oral prednisone on days 4-8. Patients
also receive sargramostim (GM-CSF) subcutaneously beginning on day 9 until blood counts
recover. Treatment repeats every 21 days for a maximum of 8 courses in the absence of
disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of intermediate grade B-cell CD20+ non-Hodgkin's
lymphoma Failed to achieve initial complete response (CR) after at least 2 courses of
standard chemotherapy OR Relapsed after CR and not eligible for autologous bone marrow
transplant Measurable disease defined as one of the following: Bidimensionally measurable
disease at least 2 cm in diameter by radiograph or CT scan Enlarged spleen extending at
least 2 cm below the costal due to lymphomatous involvement Enlarged liver with focal
lesions on CT scan or biopsy proven lesions Lymphomatous hepatic involvement must be
biopsy proven for the liver to be sole area of measurable disease No evidence of CNS
involvement A new classification scheme for adult non-Hodgkin's lymphoma has been adopted
by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former
terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol
uses the former terminology.

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3* Platelet count
at least 100,000/mm3* *unless there is bone marrow involvement with lymphoma Hepatic:
Bilirubin less than 3 mg/dL AST/ALT less than 2 times normal Renal: Creatinine less than
2.1 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF greater than
45% by MUGA or echocardiogram Other: No prior malignancy within the past 10 years except
squamous cell carcinoma or basal cell carcinoma of the skin or cervical cancer No evidence
of infection HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior rituximab

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Sein Aung, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center


United States: Federal Government

Study ID:




Start Date:

September 1999

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



Franklin Square Hospital Center Baltimore, Maryland  21237
Washington Cancer Institute Washington, District of Columbia  20010