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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Trial of Brief Duration Combination Chemotherapy and Rituximab With Prophylactic Pegfilgrastim, Followed by Maintenance Rituximab, in Elderly/Poor Performance Status Patients With Large B-Cell Non-Hodgkin's Lymphoma

Conditions
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Non-Hodgkins Lymphoma

Intervention / Treatment
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* Drug: Cyclophosphamide
* Drug: Mitoxantrone
* Drug: Vincristine
* Drug: Prednisone
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone<br>All patients receive three courses of combination chemotherapy/rituximab followed by pegfilgrastim, administered at 21-day intervals. Treatment administered is as follows: cyclophosphamide 500mg/m2 IV day 1; mitoxantrone 10mg/m2 IV day 1; vincristine 1.0mg/m2 (maximum 2mg) IV day 1; prednisone 80mg PO days 1 - 5; rituximab 375mg/m2 IV day 1. | Drug: Cyclophosphamide<br>* Cyclophosphamide<br>* Other names: Cytoxan;Drug: Mitoxantrone<br>* Mitoxantrone<br>* Other names: Novantrone;Drug: Vincristine<br>* Vincristine<br>* Other names: Oncovin;Drug: Prednisone<br>* Prednisone<br>Drug: Rituximab<br>* Rituximab<br>* Other names: Rituxan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 Months |