CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Cyclophosphamide +4 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • Histologically confirmed large B-cell, CD20-positive non-Hodgkin's lymphoma
  • No prior treatment for lymphoma
  • Clinical stage II, III, or IV disease
  • Age older than 70 years
Key exclusion· 5
  • Central nervous system involvement with lymphoma
  • Coexistent active malignancies treated within five years
  • Active infection precluding combination chemotherapy
  • HIV infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00193479
NCT00193479Phase 2Completed

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

SCRI Development Innovations, LLC·interventional·Posted Sep 19, 2005·Updated Mar 3, 2022

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Mitoxantrone, and 3 other interventions for Non-Hodgkins Lymphoma. Completed, enrolled 51 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc., Amgen

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartApr 1, 2003
Primary CompletionJul 1, 2008
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.8 years ago

Interventions

Cyclophosphamidedrug

Cyclophosphamide

Mitoxantronedrug

Mitoxantrone

Vincristinedrug

Vincristine

Prednisonedrug

Prednisone

Rituximabdrug

Rituximab