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Clinical Trial Summary

In this study, participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA)-matched related/sibling donor (MSD), matched unrelated donor (MURD) or killer-immunoglobulin receptors (KIR) ligand mismatched haploidentical donor identified, will receive an umbilical cord blood transplantation (UCBT) using a myeloablative preparative regimen.

The preparative regimen includes fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (10.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1.


Clinical Trial Description

The primary objectives is to estimate the event-free survival (EFS) at one-year post-transplant for research participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation (HCT) using single unit umbilical cord blood (UCB).

Secondary objectives are:

- Describe the clinical outcome of patients undergoing a double unit UCBT.

- Estimate the incidence and severity of acute and chronic graft versus host disease (GVHD) of patients enrolled in the research arm.

- Estimate the incidence and time to neutrophil and platelet engraftment among patients enrolled in the research arm.

- Estimate the incidence of transplant related mortality (TRM) and transplant related morbidity in the first 100 days after transplantation among patients enrolled in the research

Exploratory Objectives are:

- Assess the relationship between pre-transplant minimal residual disease (MRD) with transplant outcomes.

- Record immune reconstitution parameters, including chimerism analysis, quantitative lymphocyte subsets, T cell receptor excision circle (TREC) and spectratyping. Immunophenotyping and functional assays of T, B and NK cells and lymphocytes will also be evaluated.

- Evaluate the determinants of engraftment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01328496
Study type Interventional
Source St. Jude Children's Research Hospital
Contact
Status Completed
Phase Phase 2
Start date June 15, 2011
Completion date October 31, 2016

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