Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
Condition: Leukemia; Myelodysplastic Syndrome; Lymphoma
MeSH terms: Hematologic Neoplasms; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): CliniMACS Fractionation system (Arm A); CliniMACS Fractionation system (Arm B); Haploidentical donor CD34+ cells
Intervention type(s): Device; Device; Biological
Intervention description(s): 7 days before transplant Admit to hospital. Line insertion 6 days before transplant Fludarabine (chemotherapy) Cyclophosphamide (chemotherapy) 5 days before transplant Fludarabine Thiotepa 4 days before transplant Fludarabine Thiotepa 3 days before transplant Fludarabine Start CSA and MMF 2 days before transplant Fludarabine and TBI (radiation therapy)
1 day before transplant TBI (radiation therapy) Day of transplant Transplant day (infuse cord blood) Day after cord blood transplant Infuse family member stem cells 7 days after transplant Start G-CSF; 8 days before transplant Admit to hospital. Line insertion 7 days before transplant Fludarabine 6 days before transplant Fludarabine Cyclophosphamide 5 days before transplant Fludarabine Cyclophosphamide 4 days before transplant Rest 3 days before transplant TBI x 3 Start CSA and MMF 2 days before transplant TBI x 3
1 day before transplant TBI x 3 Day of transplant TBI x 2 then infuse cord blood
1 day after the cord blood transplant Infuse family member stem cells 7 days after transplant Start G-CSF; 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CYCLOPHOSPHAMIDE (CYTOXAN); CYCLOSPORINE; FLUDARABINE; G-CSF; MYCOPHENOLATE MOFETIL (MMF); Cord Blood Transplantation; CliniMACS; 12-153