Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus

PHASE2CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

January 30, 2004

Primary Completion Date

October 15, 2013

Study Completion Date

October 15, 2013

Conditions
Lupus Erythematosus, Systemic
Interventions
DRUG

fludarabine phosphate

Conditioning and transplant regimen: 30 mg/m\^2 day intravenous infusion over 30 minutes daily, 4 days (transplant days -6, -5, -4, -3)

DRUG

cyclophosphamide

Priming regimen: 2000 mg/m\^2 intravenous infusion over 2 hours, day 2. Conditioning and transplant regimen: 1200 mg/m\^2 day intravenous infusion daily, 4 days (-6, -5, -4, -3).

BIOLOGICAL

Rituxan (rituximab)

Priming regimen: 375 mg/m\^2 intravenous day 1, 4. Conditioning and transplant regimen: 750 mg/m\^2 intravenous infusion, day -7.

BIOLOGICAL

filgrastim

Priming regimen: 10 micrograms/kg/day subcutaneous, starting day 6. Conditioning and transplant regimen: 5 micrograms/kg/day subcutaneous, day +1 until ANC \>500 microliters.

DRUG

methylprednisolone

Priming regimen:1000 mg intravenous over 30 minutes, day 1.

OTHER

immunologic technique

Lymphoablative regimen using cyclophosphamide, rituximab, and fludarabine followed by a CD34 cell selected autologous stem cell transplant.

OTHER

laboratory biomarker analysis

Standard human immunology research laboratory ex vivo studies.

PROCEDURE

autologous hematopoietic stem cell transplantation

Day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous.

DRUG

Diphenhydramine

Conditioning and transplant regimen 25-50 mg orally or intravenously.

DRUG

Mesna

Priming regimen: 600 mg/m\^2 intravenous immediately prior to cyclophosphamide and repeat at 4 and 7 hours after the first dose, day 2. Conditioning and transplant regimen:1200 mg/m\^2 per day continuous 24 hour intravenous infusion, daily for 4 days, start concurrently with the start of cyclophosphamide.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00076752 - Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter