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Sponsored by: |
University of Arizona |
---|---|
Information provided by: | University of Arizona |
ClinicalTrials.gov Identifier: | NCT00618969 |
The purpose of this study is to transplant haploidentical related peripheral blood stem cells (PBSCs) that come from a relative such as a parent, sibling, a child or other relative who has a half-matched tissue type with the recipient (rather than being completely matched) following administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab.
Condition | Intervention | Phase |
---|---|---|
Hematologic Neoplasms Anemia, Aplastic Hemoglobinuria, Paroxysmal Multiple Myeloma |
Other: haploidentical allogeneic PBSC transplant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Peripheral Blood Stem Cell Transplantation (PBSCT)From Haploidentical Related Donors for Treatment of Hematologic Malignancies and Hematopoietic Failure States |
Estimated Enrollment: | 60 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
haploidentical related PBSC following reduced-intensity regimen of busulfan, melphalan and alemtuzumab
|
Other: haploidentical allogeneic PBSC transplant
Days -8 and -7: IV busulfan 3.2 mg/kg/dose daily for 2 days Day -6: IV melphalan 100 mg/m2 as a single dose Days -5 through -1: IV alemtuzumab 20 mg/dose daily for 5 days Day 0: Transplantation of haploidentical related allogeneic peripheral blood stem cells (PBSCs)- target cell dose 10 x 106 donor CD34+ cells per kilogram of recipient weight |
Fewer than 35% of patients who might benefit from allogeneic HCT have an HLA-identical sib. Transplantation of peripheral blood stem cells (PBSCs) or bone marrow (BM)from HLA-matched or one-locus mismatch unrelated volunteer donors may be an alternative in some patients who lack HLA-matched sib donors.
Despite increasing numbers of volunteer unrelated donors in national and international registries, identification of suitable unrelated donors who are matched with the recipient at all HLA-A, -B, -C and -DRB1 loci (8/8 HLA match) or mismatched at one of those loci (7/8 HLA match) is still challenging, especially for patients who are African-American or multiracial. Additionally, the 3- to 4-month delay between initiation of unrelated donor search to HCT is unacceptably long in patients with aggressive hematologic malignancies that are likely to relapse or progress during that interval.
Transplantation of single or dual unrelated umbilical cord blood cells (UCB) units is another alternative, although problems with inadequate cell doses, delayed engraftment, graft rejection and infection persist in adult recipients of unrelated UCB transplants.
This is a phase II single-arm open-label study to evaluate the efficacy and safety of haploidentical related allogeneic PBSCT using a nonmyeloablative preparative regimen of intravenous busulfan (Busulfex®), intravenous melphalan (Alkeran®) and intravenous alemtuzumab (Campath®) in subjects who are candidates for related or unrelated allogeneic hematopoietic cell transplantation (HCT; transplantation of bone marrow or PBSCs) but who lack histocompatible related or unrelated donors. This study will also evaluate immunological reconstitution following haploidentical PBSCT by measurement of circulating T cell receptor excision circle (TREC)-positive cells, an indicator of thymic output. Systematic analyses of TREC-positive cells have not been performed in recipients of haploidentical PBSCT after the preparative regimen described in this protocol.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrew M Yeager, MD | 520-626-3191 | ayeager@azcc.arizona.edu |
Contact: Phyllis Schneider, RN | 520-694-9070 | pschneider@azcc.arizona.edu |
United States, Arizona | |
Arizona Cancer Center/University Medical Center | Recruiting |
Tucson, Arizona, United States, 85719 | |
Contact: Andrew M Yeager, MD 520-626-3191 ayeager@azcc.arizona.edu | |
Contact: Phyllis Schneider, RN 520-694-9070 pschneider@azcc.arizona.edu | |
Principal Investigator: Andrew M Yeager, MD |
Principal Investigator: | Andrew M Yeager, MD | University of Arizona |
Principal Investigator: | Andrew M Yeager, MD | University of Arizona |
Responsible Party: | Arizona Cancer Center/University Medical Center ( Andrew M. Yeager, MD ) |
Study ID Numbers: | BIO 07-122 |
Study First Received: | February 8, 2008 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00618969 History of Changes |
Health Authority: | United States: Institutional Review Board |
Haploidentical peripheral blood stem cell transplantation leukemia |
myeloma Hodgkin's disease non-Hodgkin's lymphoma |
Melphalan Immunologic Factors Hematologic Neoplasms Aplastic Anemia Blood Protein Disorders Paraproteinemias Hemostatic Disorders Lymphoma, Small Cleaved-cell, Diffuse Leukemia Signs and Symptoms Preleukemia Hemorrhagic Disorders Urologic Diseases Alemtuzumab Hemoglobinuria, Paroxysmal |
Anemia, Aplastic Alkylating Agents Hodgkin Disease Lymphoma Immunoproliferative Disorders Hodgkin Lymphoma, Adult Hematologic Diseases Urination Disorders Blood Coagulation Disorders Myelodysplastic Syndromes Anemia Vascular Diseases Hodgkin's Disease Anemia, Hemolytic Immunosuppressive Agents |
Melphalan Molecular Mechanisms of Pharmacological Action Immunologic Factors Hematologic Neoplasms Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Signs and Symptoms Neoplasms by Site Hemorrhagic Disorders Urologic Diseases Therapeutic Uses Hemoglobinuria, Paroxysmal |
Anemia, Aplastic Cardiovascular Diseases Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Urination Disorders Hematologic Diseases Myelodysplastic Syndromes Anemia Vascular Diseases Anemia, Hemolytic Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma |