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Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)

NCT02080195 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-10-02

Study results available
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Summary

The main goal of the study is to determine if bone marrow transplant (BMT) from a less specific pool of donors in combination with high dose cyclophosphamide can induce remission of refractory systemic lupus erythematosus.

Conditions

  • Lupus Erythematosus
  • Graft-versus-host Disease

Interventions

DRUG

Cyclophosphamide

14.5 mg/kg/day on Days -6 and -5. 50 mg/kg/day on Days 3 and 4.

DRUG

Fludarabine

30 mg/m\^2/day on Days -6 through -2.

DRUG

Tacrolimus

Starting on Day 5. Dose will be adjusted according to blood levels.

DRUG

Mycophenolate Mofetil

15 mg/kg three times per day from Day 5 to Day 35.

DRUG

Rabbit antithymocyte globulin

0.5 mg/kg on Day -9. 2 mg/kg/day on Days -8 and -7.

RADIATION

Total body irradiation

200 centigray on Day -1.

BIOLOGICAL

Allogeneic bone marrow transplant

Infusion on Day 0.

Sponsors & Collaborators

  • Maryland Stem Cell Research Fund

    collaborator UNKNOWN

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Javier Bolaños-Meade, MD · The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-09-13
Primary Completion
2017-03-28
Completion
2017-03-29

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 NCT02080195 on ClinicalTrials.gov