NCT00006669

Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to kill cancer cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of rituximab followed by combination chemotherapy in treating patients who have refractory or recurrent non-Hodgkin's lymphoma.

Detailed description

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab
BIOLOGICAL	sargramostim
DRUG	EPOCH regimen
DRUG	cyclophosphamide
DRUG	doxorubicin hydrochloride
DRUG	etoposide
DRUG	prednisone
DRUG	vincristine sulfate

Timeline

• Start date: 1999-09-01
• Primary completion: 2000-01-01
• Completion: 2000-01-01
• First posted: 2004-05-04
• Last updated: 2021-10-27

Locations

2 sites across 1 country: United States