Hematologic Malignancies Clinical Trial
Official title:
Umbilical Cord Blood Transplantation In Patients With Hematologic Malignancies Using A Myeloablative Preparative Regimen
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.
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.
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