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Completed

NCT Number: NCT01364363

Unrelated Donor Stem Cell Transplantation

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.

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Key information

Conditions

Severe Aplastic Anemia Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia Anemia Anemia, Aplastic Anemia, Hemolytic Blood Protein Disorders Bone Marrow Diseases Bone Marrow Failure Disorders Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia Chronic Myelogenous Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinuria, Paroxysmal Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Hodgkin's Lymphoma Immune System Diseases Immunoproliferative Disorders Large Granulocytic Leukemia Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Myelodysplastic Syndromes Myeloproliferative Disorders Myeloproliferative Syndromes Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non-Hodgkin's Lymphoma Paraproteinemias Paroxysmal Nocturnal Hemoglobinuria Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Small Lymphocytic Lymphoma Vascular Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Green Hospital

La Jolla, California, 92037, United States

About this study

same

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allogeneic transplantation

Procedure

Allogeneic transplantation with matched unrelated donors

Other names: MUD transplant

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Scripps Health

Other

Registry information

Official study title

Allogeneic Hematopoietic Progenitor Cell Transplantation From Unrelated Donors

Important dates

Study start
2005
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2011
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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