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Unrelated Donor Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01364363
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : November 23, 2022
Sponsor:
Information provided by (Responsible Party):
Scripps Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Procedure: Allogeneic transplantation Not Applicable

Detailed Description:
same
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Hematopoietic Progenitor Cell Transplantation From Unrelated Donors
Study Start Date : March 2005
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

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


Outcome Measures
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Primary Outcome Measures :
  1. Bone Marrow and Peripheral Blood Chimerism [ Time Frame: 30 days post-transplant ]
    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.

  2. Bone Marrow and Peripheral Blood Chimerism [ Time Frame: 100 days post-transplant ]
    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.

  3. Bone Marrow and Peripheral Blood Chimerism [ Time Frame: 365 days post-transplant ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364363


Locations
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United States, California
Scripps Green Hospital
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Health
Investigators
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Principal Investigator: Jeffrey W. Andrey, MD Scripps Clinic Medical Group
More Information
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Responsible Party: Scripps Health
ClinicalTrials.gov Identifier: NCT01364363    
Other Study ID Numbers: SIRB#13-6190
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Keywords provided by Scripps Health:
Transplant
Allogeneic
Allogeneic transplant
Unrelated donor transplant
 MUD
HSCT
Stem cell transplant
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Multiple Myeloma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Hemoglobinuria
Myelodysplastic Syndromes
Anemia, Aplastic
Hemoglobinuria, Paroxysmal
Syndrome
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases