A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

August 20, 2012

Primary Completion Date

February 10, 2020

Study Completion Date

February 10, 2020

Conditions
Ewing SarcomaGastrointestinal TumorGerm Cell TumorHepatic TumorLymphomaWilms TumorRhabdoid TumorClear Cell CarcinomaRenal Cell CarcinomaMelanomaNeuroblastomaRhabdomyosarcomaNon-rhabdomyosarcoma
Interventions
DRUG

alemtuzumab

Patients receive alemtuzumab on days -14 through -12 (Day 0 = stem cell transplantation).

DRUG

fludarabine

Patients receive fludarabine phosphate on days -11 through -7. (Day 0 = stem cell transplantation.)

DRUG

sirolimus

"Patients receive sirolimus beginning on day -1 with taper beginning on day 90. (Day 0 = stem cell transplantation.)~Participants treated after activation of protocol revision 2.3 on 06/05/2014 have not and will not receive sirolimus as part of their therapy."

DRUG

Busulfan

Patients receive busulfan on days -6 through -3. (Day 0 = stem cell transplantation.)

DRUG

melphalan

Patients receive melphalan on days -2 and -1. (Day 0 = stem cell transplantation.)

BIOLOGICAL

stem cells

Patients undergo CD3 depleted haploidentical hematopoietic stem cell transplant (HSCT) on day 0. Patients also undergo CD45RA depleted HSCT infusion on day 1. (Day 0 = stem cell transplantation.)

DEVICE

CliniMACS

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
collaborator

CURE Childhood Cancer, Inc.

OTHER

lead

St. Jude Children's Research Hospital

OTHER

NCT01625351 - A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas | Biotech Hunter | Biotech Hunter