Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University of Michigan Cancer Center |
---|---|
Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00146055 |
The purpose of this study is to determine whether a less-intensive preparative therapy followed by an allogeneic peripheral stem cell transplantation will provide an effective treatment for your disease and whether it will be associated with fewer side effects.
Condition | Intervention | Phase |
---|---|---|
Myeloma, Plasma-Cell Lymphoma, Malignant Myeloproliferative Disorders Myelodysplastic Syndromes Waldenstrom's Macroglobulinemia |
Procedure: Reduced intensity conditioning with allogeneic transplant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Low-Intensity Preparative Regimen and Allogeneic Peripheral Blood Stem Cell Transplantation From Unrelated Donor in Patients With Hematologic Malignancy |
Estimated Enrollment: | 60 |
Study Start Date: | March 2000 |
Study Completion Date: | October 2007 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Combinations of high-dose chemotherapy and radiation therapy (preparative regimen) followed with allogeneic bone marrow or stem cell transplantation from an unrelated donor is a current treatment approach. Chemotherapeutic drugs and radiation are given in higher doses to increase their effectiveness. High-dose chemotherapy and radiation therapy generally affect cells that are dividing. They are used to treat cancer because cancer cells divide more often than most other cells. High-dose treatment severely damages the patient's bone marrow so that the patient no longer is able to produce needed blood cells. Peripheral stem cell transplantation allows stem cells that were damaged by treatment to be replaced with healthy stem cells that can produce the blood cells the patient needs. Patients experience a number of complications after transplantation. Some are temporary and relatively minor; yet others can be life threatening. Many doctors consider high-dose chemotherapy, by itself or with radiation, and bone marrow or stem cell transplantation as the best available treatment option for diseases under specific circumstances. However, this study will explore whether a less-intensive preparative therapy before the peripheral stem cell transplantation will prove to be safer, have less side effects, and be an effective treatment for certain diseases.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must be a candidate for unrelated donor stem cell transplantation and the donor and recipient must be 5/6 or 6/6 matched. In addition, patients must have one of the following histologically confirmed diagnosis
Patients with previously treated AML (M0 - M7 by FAB classification)
Patients with acute lymphoblastic leukemia
Patients with myeloma or plasma cell neoplasms who are :
Exclusion Criteria:
United States, Michigan | |
The University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | John E. Levine, MS MD | The Univeristy of Michigan |
Study ID Numbers: | UMCC 9970 |
Study First Received: | September 1, 2005 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00146055 History of Changes |
Health Authority: | United States: Institutional Review Board |
Immunoproliferative Disorders Precancerous Conditions Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Myelodysplastic Syndromes Myeloproliferative Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Lymphatic Diseases Preleukemia Waldenstrom Macroglobulinemia Hemorrhagic Disorders Bone Marrow Diseases Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
Precancerous Conditions Blood Protein Disorders Paraproteinemias Hemostatic Disorders Preleukemia Hemorrhagic Disorders Pathologic Processes Syndrome Cardiovascular Diseases Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Disease |
Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Vascular Diseases Multiple Myeloma Lymphatic Diseases Neoplasms Waldenstrom Macroglobulinemia Lymphoproliferative Disorders Bone Marrow Diseases Neoplasms, Plasma Cell |