Back to resultsUnrelated Donor Stem Cell Transplantation
Primary Purpose
Severe Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria, Acute Myelogenous Leukemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Allogeneic transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Severe Aplastic Anemia focused on measuring Transplant, Allogeneic, Allogeneic transplant, Unrelated donor transplant, MUD, HSCT, Stem cell transplant
Eligibility Criteria
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
Sites / Locations
- Scripps Green Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Other
Other
Other
Other
Other
Other
Other
Arm Label
Total Body Irradiation/VP16
Cytoxan/Total Body Irradiation
Busulfan/Cytoxan
BEAM (BCNU, etoposide, Ara-C, melphalan)
Total Lymphoid Irradiation
Cladribine/Melphalan
FLAG (fludarabine, Ara-C, G-CSF)
Arm Description
Acute Leukemias, Myelodysplastic syndromes
Chronic Leukemias, Bone Marrow Failure States, Lymphomas, Hodgkin's Disease
Acute Leukemia, Myelodysplastic syndromes, Chronic Leukemias, Bone Marrow Failure states
Lymphomas, Hodgkin's Disease
For patients with Multiple Myeloma, or prior autologous transplantation, or age in excess of 55
For patients with Multiple Myeloma, or prior autologous transplantation, or age in excess of 55
For patients undergoing a second allogeneic transplant
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01364363
Brief Title
Unrelated Donor Stem Cell Transplantation
Official Title
Allogeneic Hematopoietic Progenitor Cell Transplantation From Unrelated Donors
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scripps Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
same
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Transplant, Allogeneic, Allogeneic transplant, Unrelated donor transplant, MUD, HSCT, Stem cell transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Total Body Irradiation/VP16
Arm Type
Other
Arm Description
Acute Leukemias, Myelodysplastic syndromes
Arm Title
Cytoxan/Total Body Irradiation
Arm Type
Other
Arm Description
Chronic Leukemias, Bone Marrow Failure States, Lymphomas, Hodgkin's Disease
Arm Title
Busulfan/Cytoxan
Arm Type
Other
Arm Description
Acute Leukemia, Myelodysplastic syndromes, Chronic Leukemias, Bone Marrow Failure states
Arm Title
BEAM (BCNU, etoposide, Ara-C, melphalan)
Arm Type
Other
Arm Description
Lymphomas, Hodgkin's Disease
Arm Title
Total Lymphoid Irradiation
Arm Type
Other
Arm Description
For patients with Multiple Myeloma, or prior autologous transplantation, or age in excess of 55
Arm Title
Cladribine/Melphalan
Arm Type
Other
Arm Description
For patients with Multiple Myeloma, or prior autologous transplantation, or age in excess of 55
Arm Title
FLAG (fludarabine, Ara-C, G-CSF)
Arm Type
Other
Arm Description
For patients undergoing a second allogeneic transplant
Intervention Type
Procedure
Intervention Name(s)
Allogeneic transplantation
Other Intervention Name(s)
MUD transplant
Intervention Description
Allogeneic transplantation with matched unrelated donors
Primary Outcome Measure Information:
Title
Bone Marrow and Peripheral Blood Chimerism
Description
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.
Time Frame
30 days post-transplant
Title
Bone Marrow and Peripheral Blood Chimerism
Description
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.
Time Frame
100 days post-transplant
Title
Bone Marrow and Peripheral Blood Chimerism
Description
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.
Time Frame
365 days post-transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey W. Andrey, MD
Organizational Affiliation
Scripps Clinic Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Unrelated Donor Stem Cell Transplantation
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