NCT02435901 - HSCT For Patients With High Risk Hemoglobinopathies Using Reduced Intensity | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

March 31, 2019

Study Completion Date

December 31, 2019

Conditions

Sickle Cell DiseaseBeta Thalassemia-Major

Interventions

DRUG

alemtuzumab (Campath IH)

Alemtuzumab (Campath IH) is given daily over first 4 days, Day -20 to Day -17

DRUG

Fludarabine

Fludarabine 35/m2 is given daily over 4 days on Day -7 to Day -4.

DRUG

Melphalan

Melphalan 70mg/m2 is given daily over 2 days on Day -3 to Day -2.

DRUG

Cyclosporine

Immunosuppressant to prevent graft vs host disease is given on Day -1 prior to stem cell infusion

DRUG

Mycophenolate mofetil

Immunosuppressant to prevent graft vs host disease is given on Day -1.

DRUG

Tacrolimus

Immunosuppressant to prevent graft vs host disease is given Day -1 prior to stem cell infusion

BIOLOGICAL

Hematopoietic Stem Cell Transplantation

Human Leukocyte Antigen (HLA) matched or mismatched; related or unrelated hematopoietic stem cells to be transplanted on Day 0.

Trial Locations (1)

Cohen Children's Medical Center of New York, New Hyde Park