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Trial record 1 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Unrelated Donors"
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Unrelated Donor Stem Cell Transplantation

This study is currently recruiting participants.
Verified December 2013 by Jeffrey Andrey, MD, Scripps Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364363
First Posted: June 2, 2011
Last Update Posted: December 6, 2013
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey Andrey, MD, Scripps Health
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Hematopoietic Progenitor Cell Transplantation From Unrelated Donors

Resource links provided by NLM:


Further study details as provided by Jeffrey Andrey, MD, Scripps Health:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.


Estimated Enrollment: 50
Study Start Date: March 2005
Estimated Study Completion Date: January 2023
Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
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
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


Contacts
Contact: Carol Burian 858-554-2845 Burian.Carol@scrippshealth.org

Locations
United States, California
Scripps Green Hospital Recruiting
La Jolla, California, United States, 92037
Contact: Carol Burian    858-554-2845    Burian.Carol@scrippshealth.org   
Principal Investigator: Jeffrey W. Andrey, MD         
Sponsors and Collaborators
Scripps Health
Investigators
Principal Investigator: Jeffrey W. Andrey, MD Scripps Clinic Medical Group
  More Information

Additional Information:
Responsible Party: Jeffrey Andrey, MD, Director, Unrelated Donor Transplantation, Scripps Health
ClinicalTrials.gov Identifier: NCT01364363     History of Changes
Other Study ID Numbers: SIRB#13-6190
First Submitted: April 4, 2011
First Posted: June 2, 2011
Last Update Posted: December 6, 2013
Last Verified: December 2013

Keywords provided by Jeffrey Andrey, MD, Scripps Health:
Transplant
Allogeneic
Allogeneic transplant
Unrelated donor transplant
MUD
HSCT
Stem cell transplant

Additional relevant MeSH terms:
Lymphoma
Syndrome
Leukemia
Multiple Myeloma
Myelodysplastic Syndromes
Preleukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Hodgkin Disease
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Anemia, Aplastic
Hemoglobinuria
Hemoglobinuria, Paroxysmal
Myeloproliferative Disorders
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