NCT00001337

Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma

Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Adults and Children With Previously Untreated Patients With Aggressive Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. Etoposide phosphate, prednisone, vincristine sulfate (Oncovin), cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin)(EPOCH): Etoposide, VP-16, NSC-141540; Prednisone, PRED, NSC-10023; Vincristine, VCR, NSC-67574; Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; with Granulocyte Colony-Stimulating Factor (Amgen), Granulocyte colony-stimulating factor (G-CSF), NSC-614629.

Detailed description

Background: The treatment of the intermediate and aggressive non-Hodgkin's lymphomas in adults and children commonly induces complete responses in a sizable fraction of the treated population, and about 2/3 of the complete responders appear to have prolonged disease-free survival. The present study assesses the activity and tolerability in previously untreated patients of a regimen of etoposide phosphate, prednisone, vincristine sulfate (Oncovin), cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin)(EPOCH) infusional chemotherapy given intensively with granulocyte colony-stimulating factor (G-CSF) support. Objectives: Primary: Assess complete response (CR) and progression-free survival (PFS) of dose-adjusted EPOCH-Rituximab (DA-EPOCH-R) with G-CSF in aggressive B-cell lymphomas. Eligibility: Non-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma (MGZL) and primary mediastinal B cell lymphoma (PMBL). Patients greater than or equal to 12 years old. Any Stage for PMBL and MGZL. No prior systemic chemotherapy. Human immunodeficiency virus (HIV) negative. Design: This study will estimate the complete response rate of a group of previously untreated patients and the extent to which EPOCH infusional drug delivery accompanied by a hematopoietic growth factor can increase the dose intensity of treatment. Patients receive prednisone orally for 5 days, a 96-hour infusion of vincristine, doxorubicin, and etoposide, and a bolus of cyclophosphamide on day 5. Cycles are repeated every 21 days for a total of 6-8 cycles. Patients with cluster of differentiation 20 (CD20) expressing tumors (i.e., mature B-cell lymphomas) will also receive rituximab, the humanized monoclonal antibody against the CD20 receptor on day 1 of each cycle. A total of 348 patients will be enrolled on this protocol.

Conditions

• Diffuse Large B-Cell Lymphoma (DLBCL)
• Primary Mediastinal Large B-cell Lymphoma
• Burkitt Lymphoma
• Anaplastic Large-Cell Lymphoma
• Gray Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Etoposide	Etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles.
BIOLOGICAL	Rituximab	Rituximab given on Day 1 of combination chemotherapy (EPOCH-R) every 3 weeks for 6 cycles. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles.
DRUG	Prednisone	Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles.
DRUG	Cyclophosphamide	Cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles.
DRUG	Vincristine	Vincristine 0.4mg/m\^2/day. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles.
DRUG	Doxorubicin	Doxorubicin 10mg/m\^2/day. Combination chemotherapy given with Rituximab, Etoposide, VP-16; Prednisone, Cyclophosphamide, Vincristine, and Doxorubicin (EPOCH-R) intravenous (IV) every 3 weeks for 6 cycles.
DIAGNOSTIC_TEST	MRI	Baseline and/or on completion of therapy.
DIAGNOSTIC_TEST	CT	Baseline and/or on completion of therapy.
PROCEDURE	Biopsy	Baseline and/or on completion of therapy.
DIAGNOSTIC_TEST	PET scan	As clinically indicated.
PROCEDURE	Laparotomy	As clinically indicated.
OTHER	Ondansetron	Nausea and/or vomiting.
OTHER	Prochlorperazine	Nausea and/or vomiting.
OTHER	Omeprazole	Gastroesophageal reflux disease (GERD).
OTHER	Docusate Sodium + Sennosides	Constipation.
OTHER	Lactulose	Constipation

Timeline

• Start date: 1993-05-08
• Primary completion: 2024-05-24
• Completion: 2024-05-24
• First posted: 1999-11-04
• Last updated: 2025-06-22
• Results posted: 2025-06-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study