CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Hematopoietic stem cell transplantationbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00278538
NCT00278538Phase 2Completed

Cyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus: Phase II Trial

Northwestern University·interventional·Posted Jan 18, 2006·Updated Feb 28, 2020

In Brief

A Phase 2 clinical trial evaluating Hematopoietic stem cell transplantation for Systemic Lupus Erythematosus. Completed, enrolled 32 participants across 2 sites.

Detailed Summary

This study is designed to examine whether treating patients with lupus with high dose cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune system), followed by return of their previously collected stem cells will result in improvement in the disease. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack body. The study purpose is to examine whether this treatment will result in improvement in the lupus disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2006
Enrollment StartSep 23, 2005
Primary CompletionDec 1, 2018
Study CompletionMay 1, 2019
TodayJul 2, 2026
Enrollment to primary: 13.2 yearsPosted 20.5 years ago

Interventions

Hematopoietic stem cell transplantationbiological

Autologous hematopoietic stem cell transplantation