Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Washington University School of Medicine |
---|---|
Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00241358 |
The purpose of this study is to determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.
Condition | Intervention | Phase |
---|---|---|
Leukemia, Myeloid, Acute Leukemia, Myelogenous, Chronic Leukemia, Lymphoblastic, Acute Lymphocytic Leukemia, Chronic Myelodysplastic Syndromes Multiple Myeloma Lymphoma, Non-Hodgkin Hodgkin Disease |
Drug: AMD3100 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study Evaluating the Safety and Efficacy of AMD3100 for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies |
Estimated Enrollment: | 44 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: AMD3100
The donor will receive AMD3100 by two different methods of administration. The first dose will be given by intravenous infusion on day -3. The following doses will be tested:
On day 1, AMD3100 240 ug/kg SQ will be administered. If the donor does not reach the target collection a second SQ dose will be administered on day 3. |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Donor criteria:
If female and of child-bearing age, must be:
Adequate neurologic function as defined by:
Patient criteria:
If female and of child-bearing age, must be:
Patient must have one of the following diagnoses:
Adequate pulmonary function defined as:
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | John F. DiPersio, M.D., Ph.D. | Washington University School of Medicine |
Responsible Party: | Washington University ( John DiPersio, M.D., Ph.D. ) |
Study ID Numbers: | 03-0349 |
Study First Received: | October 17, 2005 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00241358 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Plerixafor Stem cell transplantation Stem cells Mobilization |
Leukemia, Lymphoid Precancerous Conditions Hematologic Neoplasms JM 3100 Blood Protein Disorders Paraproteinemias Leukemia, Myeloid, Acute Hemostatic Disorders Leukemia Preleukemia Hemorrhagic Disorders Anti-Retroviral Agents Leukemia, Lymphocytic, Chronic, B-Cell Hodgkin Disease Lymphoma |
Acute Lymphoblastic Leukemia Anti-HIV Agents Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hodgkin Lymphoma, Adult Hematologic Diseases Blood Coagulation Disorders Myelodysplastic Syndromes Myeloproliferative Disorders Vascular Diseases Hodgkin's Disease Leukemia, Myeloid Antiviral Agents Multiple Myeloma Lymphatic Diseases |
Anti-Infective Agents Leukemia, Lymphoid Precancerous Conditions Hematologic Neoplasms JM 3100 Blood Protein Disorders Paraproteinemias Hemostatic Disorders Leukemia, Myeloid, Acute Leukemia Preleukemia Neoplasms by Site Pathologic Processes Hemorrhagic Disorders Anti-Retroviral Agents |
Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Syndrome Cardiovascular Diseases Lymphoma Hodgkin Disease Anti-HIV Agents Disease Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Vascular Diseases |