Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma
- Conditions
- Non-Hodgkins Lymphoma
- Interventions
- Registration Number
- NCT00193479
- Lead Sponsor
- SCRI Development Innovations, LLC
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone Cyclophosphamide 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. Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone Prednisone 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. Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone Mitoxantrone 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. Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone Vincristine 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. Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone Rituximab 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.
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment 18 Months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States