Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma

Phase 2CompletedNCT00193479

SCRI Development Innovations, LLC51 enrolled

Overview

The purposes of this trial are to decrease toxicity and improve treatment effectiveness elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone, vincristine, and prednisone with concurrent administration of rituximab it is likely to be as effective as longer programs, and will certainly be better tolerated by this patient group. The addition of maintenance therapy may result in substantial prolongation of remission duration.

Upon determination of eligibility, patients will receive: * Cyclophosphamide + Mitoxantrone + Vincristine + Prednisone + Rituximab Patients that are not considered candidates for anthracycline therapy will not receive mitoxantrone. Patients with objective response (partial or complete response) or stable disease will receive Rituximab maintenance therapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Hodgkins Lymphoma

Interventions

CyclophosphamideDRUG

Cyclophosphamide

MitoxantroneDRUG

Mitoxantrone

VincristineDRUG

Vincristine

Prednisone

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: To be included in this study, you must meet the following criteria: * Histologically documented large B-cell, CD20-positive non-Hodgkin's lymphoma * No previous treatment * Clinical stage II, III, or IV by the Ann Arbor Staging Criteria * Age \> 70 years * ECOG performance status 0, 1, or 2 * Adequate bone marrow, liver and kidney function * Must give written informed consent prior to entering this trial Exclusion Criteria: You cannot participate in this study if any of the following apply to you: * Age \< 18 years * Central nervous system involvement with lymphoma * Coexistent active malignancies treated within five years * Active infection precluding the use of combination chemotherapy * HIV infection * Pregnant or lactating Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Locations (2)

Florida Cancer Specialists

Fort Myers, Florida, United States

Tennessee Oncology

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time frame: 18 Months

Data from ClinicalTrials.gov

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