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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

September 13, 2016

Primary Completion Date

March 28, 2017

Study Completion Date

March 29, 2017

Conditions
Lupus ErythematosusGraft-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.

Trial Locations (1)

21205

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

Sponsors
All Listed Sponsors
collaborator

Maryland Stem Cell Research Fund

UNKNOWN

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT02080195 - Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE) | Biotech Hunter | Biotech Hunter