Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

August 31, 2022

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
Neuroblastoma
Interventions
DRUG

Anti Thymocyte Globulin

2.5 mg/kg/day;2 doses on day -3 and day -2 for matched sibling donor transplantation;3 doses on day -4,-3 and day -2 for unrelated donor transplantation;4 doses on day -5,-4,-3 and day -2 for haploidentical donor transplantation

DRUG

Fludarabine

30 mg/m2/day for 5 days

DRUG

Cyclophosphamide injection

60 mg/kg/day for 2 days in cord blood stem cell transplantation

DRUG

Topotecan

2mg/m2/day for 3 days in cord blood stem cell transplantation

DRUG

Melphalan

70mg/m2/day,for peripheral stem cell transplantation or haploidentical bone marrow combined with peripheral stem cell transplantation;2 doses on day -3 and day -2 when conditioning regimen containing thiotepa;3 doses on day -4,-3 and day -2 when conditioning regimen not containing thiotepa;

DRUG

Thiotepa

5 mg/kg/day for 2 days in peripheral stem cell transplantation or haploidentical bone marrow combined with peripheral stem cell transplantation

DRUG

Busulfan

0.8mg/kg/dose;8 doses in cord blood stem cell transplantation;12 doses in peripheral stem cell transplantation or haploidentical bone marrow combined with peripheral stem cell transplantation when conditioning regimen containing thiotepa;16 doses in peripheral stem cell transplantation or haploidentical bone marrow combined with peripheral stem cell transplantation when conditioning regimen not containing thiotepa;

DRUG

Cyclosporine

2.5\~4 mg/kg/dose every 12 hours orally;1.5\~2 mg /kg/dose every 12 hours intravenously; trough concentration maintained at 150\~250ng/ml

DRUG

Tacrolimus

0.02\~0.03 mg/kg/day as continuous infusion or 12 hour divided doses

DRUG

Mycophenolate Mofetil

15 mg/kg/dose every 12 hours

DRUG

Methotrexate

15 mg/m2/dose on d+1 and 10 mg/m2/dose on d+3,d+6 in peripheral stem cell transplantation

Trial Locations (1)

510120

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER