Stem Cell Transplantation for Sickle Cell Anemia

PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

September 30, 2021

Study Completion Date

September 30, 2021

Conditions
Sickle Cell Disease
Interventions
DRUG

Alemtuzumab

"Adjusted Ideal Body Weight Formula: AIBW = IBW + \[(0.4) x (ABW - IBW)\]~b) Medications~i.) Alemtuzumab I. Hb S% must be \< or = 45% within 7 days prior to initiation of Alemtuzumab II. Iron chelation and hydroxyurea must be discontinued \>48 hours before initiating therapy III. Alemtuzumab will be diluted in 100mL of 0.9% NS and infused at a rate as below"

DRUG

Fludarabine

I. Fludarabine should be diluted in 100 ml 0.9%NS and given over 30 minutes. II. A daily dose of an antiemetic should be given 30 minutes prior to administration of the Fludarabine

DRUG

Melphalan

"I. Melphalan should be diluted in 0.9%NS to a concentration of 0.1 -0.45 mg/mL and given over 45 minutes. \*Entire dose must be infused within 60 minutes of reconstitution in Pharmacy.~II. A daily dose of an antiemetic should be given 30 minutes prior to administration of the Melphalan III. Patients should be encouraged to suck on a popsicle or something similar during the Melphalan infusion."

PROCEDURE

Stem Cells

Infusion of Hematopoietic Stem Cells

Trial Locations (1)

07601

Hackensack University Medical Center, Hackensack

All Listed Sponsors
lead

Hackensack Meridian Health

OTHER

NCT01877837 - Stem Cell Transplantation for Sickle Cell Anemia | Biotech Hunter | Biotech Hunter