Unrelated Donor Stem Cell Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to provide an opportunity for patients with malignancies or bone marrow failure states who lack a suitable sibling donor to undergo allogeneic hematopoietic progenitor cell transplantation using cells from unrelated individuals or cord blood registries.

Detailed Description
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same

Official Title
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Allogeneic Hematopoietic Progenitor Cell Transplantation From Unrelated Donors

Conditions
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Severe Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Myeloproliferative Syndromes, Chronic Myelogenous Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Large Granulocytic Leukemia

Intervention / Treatment
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* Procedure: Allogeneic transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years of Age < 70 years ECOG performance status 0, 1 or 2 Left Ventricular Ejection Fraction > 30% Creatinine clearance > 40ml/min Transaminases < 2X normal Total bilirubin < 2X normal HIV seronegativity Weight < 70kg for cord blood transplantation Ability to cover the cost of the transplant, necessary medications, and transportation/housing. Caregiver must be available while outpatient Exclusion Criteria: Greater than one antigen mismatch at HLA-A, B, C or DR plus one allele mismatch at HLA-A, B, C or DR

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Total Body Irradiation/VP16<br>Acute Leukemias, Myelodysplastic syndromes | Procedure: Allogeneic transplantation<br>* Allogeneic transplantation with matched unrelated donors<br>* Other names: MUD transplant;|
| Other: Cytoxan/Total Body Irradiation<br>Chronic Leukemias, Bone Marrow Failure States, Lymphomas, Hodgkin's Disease | Procedure: Allogeneic transplantation<br>* Allogeneic transplantation with matched unrelated donors<br>* Other names: MUD transplant;|
| Other: Busulfan/Cytoxan<br>Acute Leukemia, Myelodysplastic syndromes, Chronic Leukemias, Bone Marrow Failure states | Procedure: Allogeneic transplantation<br>* Allogeneic transplantation with matched unrelated donors<br>* Other names: MUD transplant;|
| Other: BEAM (BCNU, etoposide, Ara-C, melphalan)<br>Lymphomas, Hodgkin's Disease | Procedure: Allogeneic transplantation<br>* Allogeneic transplantation with matched unrelated donors<br>* Other names: MUD transplant;|
| Other: Total Lymphoid Irradiation<br>For patients with Multiple Myeloma, or prior autologous transplantation, or age in excess of 55 | Procedure: Allogeneic transplantation<br>* Allogeneic transplantation with matched unrelated donors<br>* Other names: MUD transplant;|
| Other: Cladribine/Melphalan<br>For patients with Multiple Myeloma, or prior autologous transplantation, or age in excess of 55 | Procedure: Allogeneic transplantation<br>* Allogeneic transplantation with matched unrelated donors<br>* Other names: MUD transplant;|
| Other: FLAG (fludarabine, Ara-C, G-CSF)<br>For patients undergoing a second allogeneic transplant | Procedure: Allogeneic transplantation<br>* Allogeneic transplantation with matched unrelated donors<br>* Other names: MUD transplant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Marrow and Peripheral Blood Chimerism | Percent of donor and host cells in peripheral blood and bone marrow will be measured by short tandem repeat (STR) testing and/or standard cytogenetic testing. | 30 days post-transplant | 
| Bone Marrow and Peripheral Blood Chimerism | Percent of donor and host cells in peripheral blood and bone marrow will be measured by short tandem repeat (STR) testing and/or standard cytogenetic testing. | 100 days post-transplant | 
| Bone Marrow and Peripheral Blood Chimerism | Percent of donor and host cells in peripheral blood and bone marrow will be measured by short tandem repeat (STR) testing and/or standard cytogenetic testing. | 365 days post-transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplant, Allogeneic, Allogeneic transplant, Unrelated donor transplant, MUD, HSCT, Stem cell transplant