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CompletedNCT01364363Updated Nov 23, 2022

Unrelated Donor Stem Cell Transplantation

An interventional study of Allogeneic transplantation in Severe Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria and Acute Myelogenous Leukemia, sponsored by Scripps Health. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2022-11-23.

Sponsored by Scripps Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years to 69 Years
Sex
All
01

Study 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.

Read the detailed description

same

02

Conditions studied

  • 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
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 64 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Scripps Health is the lead sponsor of 45 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Other
    Total Body Irradiation/VP16

    Acute Leukemias, Myelodysplastic syndromes

    Procedure: Allogeneic transplantation

  • Other
    Cytoxan/Total Body Irradiation

    Chronic Leukemias, Bone Marrow Failure States, Lymphomas, Hodgkin's Disease

    Procedure: Allogeneic transplantation

  • Other
    Busulfan/Cytoxan

    Acute Leukemia, Myelodysplastic syndromes, Chronic Leukemias, Bone Marrow Failure states

    Procedure: Allogeneic transplantation

  • Other
    BEAM (BCNU, etoposide, Ara-C, melphalan)

    Lymphomas, Hodgkin's Disease

    Procedure: Allogeneic transplantation

  • Other
    Total Lymphoid Irradiation

    For patients with Multiple Myeloma, or prior autologous transplantation, or age in excess of 55

    Procedure: Allogeneic transplantation

  • Other
    Cladribine/Melphalan

    For patients with Multiple Myeloma, or prior autologous transplantation, or age in excess of 55

    Procedure: Allogeneic transplantation

  • Other
    FLAG (fludarabine, Ara-C, G-CSF)

    For patients undergoing a second allogeneic transplant

    Procedure: Allogeneic transplantation

Interventions

  • ProcedureAllogeneic transplantation

    Allogeneic transplantation with matched unrelated donors

    Also known as: MUD transplant

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days post-transplant

  2. 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.

    Time frame: 100 days post-transplant

  3. 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.

    Time frame: 365 days post-transplant

07

Study locations

1 site
  • Scripps Green Hospital
    La Jolla, California 92037, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01364363
Lead sponsor
Scripps Health
Responsible party
Sponsor
First posted
Jun 2, 2011
Start date
Mar 2005
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Nov 23, 2022

Study contacts

Jeffrey W. Andrey, MD
principal investigator · Scripps Clinic Medical Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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