Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus

ClinicalTrials.gov ID: NCT00278538

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT00278538
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Northwestern University; Other
Enrollment: 32 participants

Conditions and interventions

Conditions

Systemic Lupus Erythematosus

Interventions

Hematopoietic stem cell transplantation Biological

Biological

Eligibility (public fields only)

Age range: 15 Years to 60 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 23, 2005 (Actual)
Primary completion: Dec 2018 (Actual)
Completion: May 2019 (Actual)
Last update posted: Feb 28, 2020

2005 – 2019

United States locations

U.S. sites: 2
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Northwestern University, Feinberg School of Medicine	Chicago	Illinois	60611	—
Northwestern University	Chicago	Illinois	60611	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00278538, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 28, 2020 · Synced Nov 15, 2026