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

PHASE2CompletedINTERVENTIONAL
Enrollment

348

Participants

Timeline

Start Date

May 8, 1993

Primary Completion Date

May 24, 2024

Study Completion Date

May 24, 2024

Conditions
Diffuse Large B-Cell Lymphoma (DLBCL)Primary Mediastinal Large B-cell LymphomaBurkitt LymphomaAnaplastic Large-Cell LymphomaGray Zone Lymphoma
Interventions
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

Trial Locations (5)

10025

St. Luke's Roosevelt Hospital, New York

20892

National Institutes of Health Clinical Center, Bethesda

33308

Holy Cross Hospital, Fort Lauderdale, Fort Lauderdale

21201-1595

University of Maryland, Baltimore, Baltimore

02115

Brigham and Women's Hospital, Boston

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH