Non-Myeloablative Conditioning and Bone Marrow Transplantation

NAActive, not recruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

November 30, 2023

Study Completion Date

December 31, 2024

Conditions
Sickle Cell DiseaseHemoglobinopathies
Interventions
DRUG

Thymoglobulin

"Day 9 before BMT: 0.5mg/kg IV; Days 8 \& 7 before BMT: 2mg/kg IV~Days 8 \& 7 - 2mg/kg IV before BMT"

DRUG

Fludarabine

Days 6 and 2 before BMT: 30mg/m2/day IV

DRUG

Cyclophosphamide (CTX)

Days 6 and 5 before BMT: 14.5mg/kg IV; Days 3 and 4 after BMT: 50mg/kg/day

DRUG

Mesna

Days 3 \& 4 after BMT: 40 mg/kg IV

DRUG

Sirolimus

Adjusted to maintain a serum trough level of 3-12 ng/mL, taken orally beginning on 5 days after BMT and taken to 1 year after BMT.

DRUG

Mycophenolate mofetil (MMF)

15 mg/kg orally with maximum dose 3 mg/day beginning 5 days after BMT and taken to day 35 after BMT

PROCEDURE

Bone marrow transplantation

Day 0 - Transplantation of hematopoietic cells derived from bone marrow of a donor to a recipient as treatment for hematologic disorders

RADIATION

Total body irradiation

200 cGy on the day before BMT. Radiation delivered to the entire body of the recipient to eradicate bone marrow cells in the recipient to prepare the recipient to receive the transplanted

Trial Locations (3)

37232

Vanderbilt-Ingram Cancer Center, Nashville

Unknown

Saint-Louis Hospital, Paris

St Mary's Hospital, London

All Listed Sponsors
lead

Vanderbilt-Ingram Cancer Center

OTHER

NCT01850108 - Non-Myeloablative Conditioning and Bone Marrow Transplantation | Biotech Hunter | Biotech Hunter