NCT00145626View on ClinicalTrials.gov

HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 31, 2004

Primary Completion Date

March 31, 2015

Study Completion Date

July 31, 2016

Conditions
Acute Myeloid LeukemiaAcute Lymphocytic LeukemiaMyelodysplasiaChronic Myeloid LeukemiaHistiocytosis
Interventions
DRUG

Chemotherapy and antibodies

Study participants will receive a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants will receive an infusion of additional donor derived cells called NK cells.

DEVICE

Miltenyi Biotec CliniMACS

Stem cell selection device

PROCEDURE

Allogeneic stem cell transplantation

Allogeneic natural killer (NK)cell infusion

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
collaborator

Assisi Foundation

OTHER

lead

St. Jude Children's Research Hospital

OTHER

NCT00145626 - HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies | Biotech Hunter | Biotech Hunter