Autologous Stem Cell Transplant for Crohn's Disease

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 12, 2017

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Crohn Disease
Interventions
PROCEDURE

Autologous stem cell transplant

Hematopoietic stem cell transplantation

DRUG

Cyclophosphamide

Days 1 and 2: Cyclophosphamide 2gm/m2/day x 2 days (total dose 4gm/m2) Day 3 until leukapheresis: G-CSF 10μg/kg/day to CD34+ \>20x104/ml then leukapheresis daily to collection goal

DRUG

Cyclophosphamide

Day -6 to -3: Cyclophosphamide 50 mg/kg/day (200 mg/kg total dose)

DRUG

Thymoglobulin

Day -3 to -1: 2.5 mg/kg/day (7.5 mg/kg total dose)

DRUG

Methylprednisolone

Day -3 to -1: 1 gram prior to each ATG dose

DRUG

Vedolizumab

Starting first day after discharge from transplant admission, then 2 weeks after 1st infusion, 4 weeks after 2nd infusion, followed by every 8 weeks for 52 weeks (8 doses)

Trial Locations (1)

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Aaron Etra

OTHER

NCT03219359 - Autologous Stem Cell Transplant for Crohn's Disease | Biotech Hunter | Biotech Hunter