Multiple Myeloma Clinical Trial
URMC Related Haplo-identical Donor BMT
Summary
This study will be a single-center treatment protocol, designed to validate the process of related donor haploidentical-SCT at the Wilmot Cancer Institute Blood and Marrow Transplant Unit.
Full Description
This study will be a single-center treatment protocol with five possible preparative regimens, designed to validate the process of related donor haploidentical-SCT at the Wilmot Cancer Institute Blood and Marrow Transplant Unit. Enrolled patients will receive chemotherapy +/- radiation as a pre-transplant conditioning regimen. Patients will then receive haploidentical stem cells, either bone marrow or mobilized peripheral blood, followed by GvHD prophylaxis that will include cyclophosphamide. Multiple data points will be collected prior to, during, and following transplantation to ensure safety of the process and to evaluate the stated objectives.
Eligibility Criteria
Inclusion Criteria:
Patient Age:
Pediatric (ages 6 months to 18 years)
Adult (ages 18-75 years)
Disease:
Congenital and Other Non-malignant Disorders
Immunodeficiency disorders (e.g. Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome)
Congenital hematopoietic stem cell defects (e.g. Chediak-Higashi Syndrome, Congenital Osteopetrosis, Osteogenesis Imperfecta)
Metabolic disorders (e.g. Hurler's Syndrome)
Hemoglobinopathies (e.g. Sickle Cell Disease, Thalassemia)
Severe aplastic anemia
High-Risk Leukemias
Acute Myelogenous Leukemia
Refractory to standard induction therapy (more than 1 cycle required to achieve remission)
Recurrent (in CR≥2)
Treatment-related AML or MDS
Evolved from myelodysplastic syndrome
Presence of Flt3 abnormalities
FAB M6 or M7
Adverse cytogenetics
Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia including T lymphoblastic leukemia
Refractory to standard induction therapy (time to CR >4 weeks)
Recurrent (in CR ≥2)
WBC count >30,000/mcL at diagnosis
Age >30 at diagnosis
Adverse cytogenetics, such as (t(9:22), t(1:19), t(4:11), other MLL rearrangements.
Chronic Myelogenous Leukemia in accelerated phase or blast crisis
Biphenotypic or undifferentiated leukemia
Burkitt's leukemia or lymphoma
Lymphoma:
Large cell, Mantle cell, Hodgkin lymphoma refractory or recurrent, chemosensitive, and ineligible for an autologous stem cell transplant or previously treated with autologous SCT
Marginal zone or follicular lymphoma that is progressive after at least two prior therapies
Multiple Myeloma, recurrent following high-dose therapy and autologous SCT or ineligible for an autologous HSCT
Solid tumors, with efficacy of allogeneic HSCT demonstrated for the specific disease and disease status
Graft failure following prior related donor, unrelated donor or UCB transplant
Myelofibrosis
Exclusion Criteria:
Patient Age below 6 months or over 75 years
Availability of a 10/10 HLA-matched related or unrelated donor within a reasonable time-frame dictated by the clinical urgency of the transplant
Autologous HSCT < 6 months prior to proposed haplo-SCT
Pregnant or breast-feeding
Current uncontrolled infection
Evidence of HIV infection or positive HIV serology
Anti-donor HLA antibodies with positive crossmatch and unsuccessful -
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There is 1 Location for this study
Rochester New York, 14642, United States
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