NCT00145613View on ClinicalTrials.gov

Haploidentical Stem Cell Transplant for Treatment Refractory Hematological Malignancies

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

July 31, 2006

Study Completion Date

February 28, 2009

Conditions
Acute Lymphoblastic Leukemia (ALL)Acute Myeloid Leukemia (AML)Secondary AMLMyelodysplastic Syndrome (MDS)Secondary MDSChronic Myeloid LeukemiaJuvenile Myelomonocytic Leukemia (JMML)Paroxysmal Nocturnal Hemoglobinuria (PNH)Lymphoma, Non-HodgkinHodgkin Disease
Interventions
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.

DEVICE

Miltenyi Biotec CliniMACS

stem cell selection device

DRUG

Systemic chemotherapy and antibodies

Transplant recipients received a non-TBI based reduced intensity conditioning regimen consisting of OKT-3, Fludarabine Thiotepa, and Melphalan. Rituximab was administered within 24 hours of the transplant in an effort to prevent PTLPD. In addition to T-cell depletion of the haploidentical stem cell product, Mycophenolate mofetil was provided as prophylaxis for GVHD.

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER

NCT00145613 - Haploidentical Stem Cell Transplant for Treatment Refractory Hematological Malignancies | Biotech Hunter | Biotech Hunter