Phase 2
Completed N=51
Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma
Source: ClinicalTrials.gov NCT00193479 ↗Enrolled (actual)
51
Serious AEs
47.1%
Results posted
Feb 2014
Primary outcomePrimary: Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment — 81 percentage of patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment |
81 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00193479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.