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Autologous Stem Cell Transplantation: International Lupus Trial

NCT05063513 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2023-09-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate remission induction therapy for refractory Lupus Erythematosus with autologous hematopoietic stem cell transplantation (AHSCT) versus Rituximab (anti CD20) followed by maintenance therapy with mycophenolate mofetil (MMF).

Conditions

  • REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS

Interventions

BIOLOGICAL

Autologous Hematopoietic Stem Cell Transplantation

Experimental arm will undergo mobilisation with CY 4 g/m2 (in two divided doses), followed by Autologous Hematopoietic Stem Cell Transplantation using CY (200 mg/kg body weight given in 4 daily doses) plus ATG and unmanipulated autologous graft and maintenance by Mycophenolate Mofetil (2 g/day) starting 3 months after randomization.

DRUG

Rituximab

Control arm will receive 4 successive weekly infusions of rituximab (antiCD20) 375 mg/m2 body surface area for four weeks and maintenance by Mycophenolate Mofetil (2 g/day) starting 3 months after randomization.

Sponsors & Collaborators

  • EULAR

    collaborator UNKNOWN

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • Dominique Farge, MD · Dept. of Internal Medicine, Hôpital Saint-Louis, 1 Avenue ClaudeVellefaux, F-75475ParisCédex 10, France.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2013-07-31
Completion
2017-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05063513 on ClinicalTrials.gov