Bone Marrow Transplantation in Young Adults With Severe Sickle Cell Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Sickle Cell Disease
Interventions
DRUG

Conditioning Regimen with Bone Marrow Transplant

"The bone marrow transplant regimen is below. Day 0 is the day of the transplant. The - sign is the number of days before and the + sign is the number of days after the transplant.~Day -8 BU 3.2 mg/ kg/dose IV~Day -7 BU 3.2 mg/kg/dose IV, FLU 35mg/m2 IV~Day -6 BU 3.2 mg/kg/dose IV, FLU 35mg/m2 IV, ATG 0.5mg/kg IV~Day -5 BU 3.2 mg/kg/dose IV, FLU 35mg/m2 IV, ATG 1.0mg/kg IV~Day -4 FLU 35mg/m2 IV, ATG 1.5mg/kg IV~Day -3 FLU 35mg/m2 IV, ATG 1.5mg/kg IV~Day -2 ATG 1.5mg/kg IV~Day -1 Rest~Day 0 Stem cell infusion~Graft Versus Host Disease (GVHD) Regimen~Day -3 Calcineurin Inhibitor (Cyclosporine or Tacrolimus) therapeutic doses through day 180, then taper~Day 0 Stem cell infusion~Day +1 Methotrexate 7.5 mg/m2 IV~Day +3 Methotrexate 7.5 mg/m2 IV~Day +6 Methotrexate 7.5 mg/m2 IV~Day+11 Methotrexate 7.5 mg/m2 IV"

Trial Locations (8)

15224

Chidren's Hospital of Pittsburgh, Pittsburgh

20010

Children's National Medical Center, Washington D.C.

23298

Virginia Commonwealth University, Richmond

27710

Duke University Medical Center, Durham

30322

Children's Healthcare of Atlanta, Atlanta

Emory University, Atlanta

33136

University of Miami, Miami

94609

Children's Hospital of Oakland, Oakland

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Emory University

OTHER

NCT01565616 - Bone Marrow Transplantation in Young Adults With Severe Sickle Cell Disease | Biotech Hunter | Biotech Hunter