Unrelated Donor Stem Cell Transplantation

NCT01364363 | Completed

• 1 other identifier: SIRB#13-6190
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

  30 days post-transplant

• 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.

  100 days post-transplant

• 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.

  365 days post-transplant

Study Arms (7)

Total Body Irradiation/VP16

OTHER

Acute Leukemias, Myelodysplastic syndromes

Procedure: Allogeneic transplantation

Cytoxan/Total Body Irradiation

OTHER

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

Procedure: Allogeneic transplantation

Busulfan/Cytoxan

OTHER

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

Procedure: Allogeneic transplantation

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

OTHER

Lymphomas, Hodgkin's Disease

Procedure: Allogeneic transplantation

Total Lymphoid Irradiation

OTHER

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

Procedure: Allogeneic transplantation

Cladribine/Melphalan

OTHER

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

Procedure: Allogeneic transplantation

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

OTHER

For patients undergoing a second allogeneic transplant

Procedure: Allogeneic transplantation

Interventions

Allogeneic transplantation PROCEDURE

Allogeneic transplantation with matched unrelated donors

Also known as: MUD transplant

BEAM (BCNU, etoposide, Ara-C, melphalan); Busulfan/Cytoxan; Cladribine/Melphalan; Cytoxan/Total Body Irradiation; FLAG (fludarabine, Ara-C, G-CSF); Total Body Irradiation/VP16; Total Lymphoid Irradiation

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• Greater than one antigen mismatch at HLA-A, B, C or DR plus one allele mismatch at HLA-A, B, C or DR

Sponsors & Collaborators

• Scripps Health: lead

Study Sites (1)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Anemia, Aplastic; Hemoglobinuria, Paroxysmal; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hodgkin Disease; Lymphoma, Non-Hodgkin; Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Transplantation, Homologous

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases; Anemia, Hemolytic; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, B-Cell

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Jeffrey W. Andrey, MD

  Scripps Clinic Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: June 2, 2011
• Study Start: March 1, 2005
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

US (1)