Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological Malignancies

PHASE2CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

December 14, 2007

Primary Completion Date

January 27, 2016

Study Completion Date

February 6, 2020

Conditions
Leukemia, Acute Lymphocytic (ALL)Leukemia, Myeloid, Acute(AML)Leukemia, Myeloid, Chronic(CML)Juvenile Myelomonocytic Leukemia (JMML)Hemoglobinuria, Paroxysmal Nocturnal (PNH)Hodgkin LymphomaLymphoma, Non-Hodgkin (NHL)Myelodysplastic Syndrome (MDS)
Interventions
DEVICE

CliniMACS

Miltenyi Biotec CliniMACS stem cell selection device

PROCEDURE

Stem cell transplantation

An infusion of HLA mismatched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device.

DRUG

Fludarabine

Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.

DRUG

Thioplex®

Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.

DRUG

L-phenylalanine mustard

Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.

DRUG

Mycophenolate mofetil

Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.

DRUG

Rituxan™

Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.

DRUG

Alemtuzumab

After January 2010, due to the unavailability of muromonab, transplant recipients received a conditioning regimen consisting of systemic chemotherapy and antibodies, including alemtuzumab.

DRUG

Cyclophosphamide

Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.

DRUG

Anti-thymocyte globulin (Rabbit)

Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.

DRUG

G-CSF

Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.

DRUG

Muromonab

Prior to January 2010, transplant participants received a conditioning regimen consisting of systemic chemotherapy and antibodies, including muromonab. Muromonab became unavailable from the manufacturer at that time and was replaced by alemtuzumab.

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER

NCT00566696 - Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological Malignancies | Biotech Hunter | Biotech Hunter