Unrelated Donor Stem Cell Transplantation

November 21, 2022 updated by: Scripps Health

Allogeneic Hematopoietic Progenitor Cell Transplantation From Unrelated Donors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

same

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Total Body Irradiation/VP16
Acute Leukemias, Myelodysplastic syndromes
Procedure: Allogeneic transplantation
Allogeneic transplantation with matched unrelated donors
Other Names:
  • MUD transplant
Other: Cytoxan/Total Body Irradiation
Chronic Leukemias, Bone Marrow Failure States, Lymphomas, Hodgkin's Disease
Procedure: Allogeneic transplantation
Allogeneic transplantation with matched unrelated donors
Other Names:
  • MUD transplant
Other: Busulfan/Cytoxan
Acute Leukemia, Myelodysplastic syndromes, Chronic Leukemias, Bone Marrow Failure states
Procedure: Allogeneic transplantation
Allogeneic transplantation with matched unrelated donors
Other Names:
  • MUD transplant
Other: BEAM (BCNU, etoposide, Ara-C, melphalan)
Lymphomas, Hodgkin's Disease
Procedure: Allogeneic transplantation
Allogeneic transplantation with matched unrelated donors
Other Names:
  • MUD transplant
Other: 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 Names:
  • MUD transplant
Other: 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 Names:
  • MUD transplant
Other: FLAG (fludarabine, Ara-C, G-CSF)
For patients undergoing a second allogeneic transplant
Procedure: Allogeneic transplantation
Allogeneic transplantation with matched unrelated donors
Other Names:
  • MUD transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days post-transplant
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.
100 days post-transplant
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.
365 days post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Health

Investigators

  • Principal Investigator: Jeffrey W. Andrey, MD, Scripps Clinic Medical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 21, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIRB#13-6190

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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