Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies

Lymphoma Clinical Trial

Official title: Myeloablative Unrelated Donor Cord Blood Transplantation With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cells for Patients With High Risk Hematological Malignancies

Status Completed

Clinical Trial Summary

The purpose of this study is to find out whether the addition of blood stem cells from a close family member, when added to umbilical cord blood will make the transplant safer.

Clinical Trial Description

This is a phase 2 study to obtain an estimate of the speed of neutrophil recovery after myeloablative double-unit cord blood (CB) transplantation (CBT) with abrogation of prolonged cytopenia by the infusion of T-cell depleted peripheral blood stem cells (PBSC) from a haplo-identical family member. The CB graft will consist of two units from unrelated newborn donors and haplo-identical related PBSC. Candidates for this trial will include patients aged 2-70 years with high-risk or advanced forms of hematologic malignancies for whom an allogeneic hematopoietic stem cell transplant is indicated and for whom no suitably human leukocyte antigen (HLA)-matched and readily available unrelated donor exists. Patients will receive myeloablative conditioning and cyclosporine-A/ mycophenolate mofetil. CB grafts will consist of two CB units 4-6/6 HLA-matched to the patient to augment graft cell dose and additional T-cell depleted PBSC from a haplo-identical donor. The aim of the haplo-identical PBSC graft is to facilitate transient engraftment and consequent abrogation of the prolonged cytopenia normally associated with CBT by providing a myeloid bridge until CB engraftment occurs. ;

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes

• NCT number: NCT01682226
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: September 5, 2012
• Completion date: January 8, 2021