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About
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.
Full description
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.
Enrollment
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Inclusion criteria
CR1 with high-risk cytogenetics t(9;22), t(8;14), t(4;11), t(1;19) for adult patients >4 wk to achieve CR1
≥ CR2 Patients should have <5% marrow blasts at the time of transplant
Exclusion criteria
Patients with suitably matched related or unrelated donors
Patients with conventional transplant options (a conventional transplant should be the priority for eligible patients ≤ 50 yr of age who have a related donor mismatched for a single HLA-A, -B or DRB1 antigen)
CNS involvement with disease refractory to intrathecal chemotherapy
Presence of active, serious infection (e.g., mucormycosis, uncontrolled aspergillosis, tuberculosis)
Karnofsky Performance Status < 60% for adult patients (Appendix A)
Patients with the following organ dysfunction:
HIV-positive patients
Women of childbearing potential who are pregnant (β-HCG+) or breast feeding
Fertile men and women unwilling to use contraceptives during and for 12 months post transplant
Life expectancy severely limited by diseases other than malignancy
Patients on any other investigational drug at time of enrolment
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Central trial contact
Rocco Pastano, MD
Data sourced from clinicaltrials.gov
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