Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkins Lymphoma |
Drug: Cyclophosphamide Drug: Mitoxantrone Drug: Vincristine Drug: Prednisone Drug: Rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Overall response rate [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2003 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
-
Drug: Cyclophosphamide
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Florida | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33901 | |
| United States, Tennessee | |
| Tennessee Oncology | |
| Nashville, Tennessee, United States, 37203 | |
| Principal Investigator: | John D. Hainsworth, MD | Sarah Cannon Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | SCRI Oncology Research Consortium, SCRI |
| ClinicalTrials.gov Identifier: | NCT00193479 History of Changes |
| Other Study ID Numbers: | SCRI LYM 28, U2675s, 20020794 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Mitoxantrone Prednisone Vincristine Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Glucocorticoids |
ClinicalTrials.gov processed this record on May 16, 2013