CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Cyclophosphamide +6 moredrug
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/NCT00787722
NCT00787722Phase 2Completed

Trial of High Dose Immunosuppressive Therapy With Hematopoietic Stem Cell Support in Devic's Disease

Northwestern University·interventional·Posted Nov 7, 2008·Updated Feb 28, 2020

In Brief

A Phase 2 clinical trial evaluating Hematopoietic Stem Cell Transplantation, Cyclophosphamide, and 5 other interventions for Devic's Disease. Completed, enrolled 13 participants across 1 site.

Detailed Summary

This study is designed to examine whether treating Devic's disease patients with high dose cyclophosphamide together with rabbit antithymocyte globulin (rATG)/rituximab (drugs which reduce the function of the immune system), followed by return of previously collected patient's stem cells will result in improvement in Devic's 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 patient's immune system, which may be causing his/her disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack patient's body. The purpose of study is to examine the safety and efficacy of this treatment. The drugs used in this study treatment are drugs for commonly used for immune suppression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDevic's Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 7, 2008
Enrollment StartOct 10, 2009
Primary CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 17.7 years ago

Interventions

Hematopoietic Stem Cell Transplantationprocedure

Infusion of participant's own stem cells

Cyclophosphamidedrug

A medication used as chemotherapy and to suppress the immune system

G-CSFdrug

A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream

rATGdrug

A rabbit polyclonal antibody to lymphocytes

Mesnadrug

A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder

Rituximabdrug

Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer

Methylprednisolonedrug

A corticosteroid medication used to suppress the immune system and decrease inflammation