CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 348 enrolled
Drug / intervention
Etoposide +15 moredrug
Likely dose
EPOCH-R: Etoposide 50 mg/m²/day IV continuous infusion over 96 hours; Prednisone 100 mg PO twice daily days 1-5; Cyclophosphamide 750 mg/m² IV day 5; Vincristine 0.4 mg/m²/day IV; Doxorubicin 10 mg/m²/day IV; Rituximab on day 1; every 3 weeks for 6 cyclesAI-extracted
Key inclusion· 8
  • Diagnosis of mediastinal gray zone lymphoma or primary mediastinal B-cell lymphoma, confirmed by NCI Hematopathology Section
  • Age ≥12 years old
  • Any stage disease
  • No prior systemic chemotherapy (prior limited-field radiotherapy, short course glucocorticoids, and/or cyclophosphamide for urgent problems at diagnosis permitted)
Key exclusion· 2
  • Other serious concomitant medical illnesses or uncontrolled active infection that would jeopardize ability to receive the regimen with reasonable safety
  • History of unrelated neoplasms within past 5 years, except non-melanoma skin cancer or in-situ cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001337
NCT00001337Phase 2Completed

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

National Cancer Institute (NCI)·interventional·Posted Nov 4, 1999·Updated Jun 22, 2025

In Brief

A Phase 2 clinical trial evaluating Etoposide, Rituximab, and 14 other interventions for Diffuse Large B-Cell Lymphoma (DLBCL) and 4 related conditions. Completed, enrolled 348 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
19931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartMay 8, 1993
Primary CompletionMay 24, 2024
TodayJul 2, 2026
Enrollment to primary: 31.0 yearsPosted 26.7 years ago

Interventions

Etoposidedrug

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.

Rituximabbiological

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.

Prednisonedrug

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.

Cyclophosphamidedrug

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.

Vincristinedrug

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.

Doxorubicindrug

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.

MRIother

Baseline and/or on completion of therapy.

CTother

Baseline and/or on completion of therapy.

Biopsyprocedure

Baseline and/or on completion of therapy.

PET scanother

As clinically indicated.

Laparotomyprocedure

As clinically indicated.

Ondansetronother

Nausea and/or vomiting.

Prochlorperazineother

Nausea and/or vomiting.

Omeprazoleother

Gastroesophageal reflux disease (GERD).

Docusate Sodium + Sennosidesother

Constipation.

Lactuloseother

Constipation