The purpose of this study is to determine if engraftment can be achieved safely in patients with high-risk hematologic malignancies who undergo non-myeloablative transplant with peripheral stem cells from Human Leukocyte Antigen (HLA) haploidentical donors with pre and post-transplant cyclophosphamide as immunosuppression.
It is important to extend the option of nonmyeloablative, hematopoietic stem cell transplantation (HSCT) for potential therapy of hematologic malignancies to patients who do not have an HLA-matched donor. Almost all patients would have a related donor identical for one HLA haplotype (haploidentical) and mismatched at HLA-A, B or DR of the unshared haplotype. Thus far, nonmyeloablative HSCT from HLA-mismatched donors has been associated with a high rate of graft failure and graft-versus-host disease (GVHD). In this protocol, we will use a combination of immunosuppressive agents including cyclophosphamide administered before and after HSCT to facilitate engraftment and to delete highly alloreactive T-cell clones presumably involved in GVHD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
14.5 mg/kg, IV qd on day -6 and -5 and 50 mg/kg, IV on day +3 and +4
Hematopoietic Stem Cell Transplantation,
European Institute of Oncology
Milan, Italy
RECRUITINGDonor engraftment
percentage of donor engraftment after 84 from baseline
Time frame: Day +84
Incidence and severity of graft versus host disease
Incidence and severity of graft versus host disease after 200 days from the baseline
Time frame: up to 200 days after the baseline
Non-relapse-related mortality
incidence of non-relapse-related mortality after 200 days from the baseline
Time frame: Incidence and severity of graft versus host disease after 200 days from the baseline
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