R-ICE and High-Dose Cyclophosphamide With PET/CT for Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Summary

This research is being done to see if a PET scan that is obtained after 3 cycles of a standard chemotherapy regimen can help guide treatment for patients with a blood disease called Non-Hodgkin's Lymphoma.

The standard treatment for newly diagnosed lymphoma is 6 to 8 cycles of chemotherapy like the CHOP combination (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). This regimen can cure about half of patients with lymphoma, but in many others disease relapses (comes back). Relapses are generally treated with more chemotherapy.

We believe that a PET scan (a type of imaging study that "lights up" in areas of cells with high activity such as lymphoma), may identify patients early who are at high risk of relapse.

The purpose of this research study is to find out if people whose treatment is changed early to an intensification regimen (high dose chemotherapy) based on a positive PET scan will have longer remissions than they would if they did not receive that high dose chemotherapy.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

BIOLOGICAL

Rituximab

375 mg/m\^2 on Day 1 of each cycle as part of R-CHOP or R-ICE. Also given 375 mg/m\^2 on Days 1, 30, and 37 as part of HiCy.

DRUG

Cyclophosphamide

750 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.

DRUG

Doxorubicin

50 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.

DRUG

Vincristine

1.4 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.

DRUG

Prednisone

100 mg/day on Days 1-5 of each cycle as part of R-CHOP.

DRUG

Ifosfamide

2000 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP.

DRUG

Carboplatin

Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function.

DRUG

Etoposide

100 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP.

DRUG

High-dose cyclophosphamide

50 mg/kg/day on Days 2-5 of HiCy.

PROCEDURE

PET scan

Performed once between Days 16-20 of cycle 3 of R-CHOP.

Sponsors & Collaborators

• Genentech, Inc.

  collaborator INDUSTRY

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  lead OTHER

Principal Investigators

• Lode Swinnen, MD · Johns Hopkins University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2014-04-30

Completion

2014-04-30

Countries

• United States

Study Locations