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Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis

NCT01047072 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-10-31

No results posted yet for this study

Summary

The purpose of the study is to see how well reduced intensity conditioning followed by a stem cell transplant from a donor (allogeneic) works in treating patients with severe systemic sclerosis. In an allogeneic stem cell transplant procedure, stem cells are taken from a healthy donor and transplanted into the patient. Stem cells can be donated by a family member or an unrelated donor who is a complete tissue type match.

Conditions

  • Systemic Scleroderma

Interventions

DRUG

fludarabine phosphate

Given IV

RADIATION

total-body irradiation

Undergo total-body irradiation

DRUG

tacrolimus

Given orally

DRUG

mycophenolate mofetil

Given orally

BIOLOGICAL

rituximab

Given IV

DRUG

cyclophosphamide

Given orally

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Undergo transplantation

PROCEDURE

peripheral blood stem cell transplantation

Undergo transplantation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    lead OTHER

Principal Investigators

  • George Georges · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2017-09-30

Countries

  • United States

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 NCT01047072 on ClinicalTrials.gov