Unrelated Donor Stem Cell Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Scripps Health
Sponsor:
Information provided by (Responsible Party):
Jeffrey Andrey, MD, Scripps Health
ClinicalTrials.gov Identifier:
NCT01364363
First received: April 4, 2011
Last updated: December 5, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Masking: 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 Scripps Health:

Primary Outcome Measures:
  • Bone Marrow and Peripheral Blood Chimerism [ Time Frame: 30 days post-transplant ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: April 4, 2011
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Scripps Health:
Transplant
Allogeneic
Allogeneic transplant
Unrelated donor transplant
MUD
HSCT
Stem cell transplant

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Hemoglobinuria
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Hemoglobinuria, Paroxysmal
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Hematologic Diseases
Bone Marrow Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014