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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004232 |
Purpose
RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of bone marrow and peripheral stem cell transplantation in treating patients who have hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous Conditions |
Biological: filgrastim Drug: cyclosporine Drug: methylprednisolone Drug: prednisone Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | Augmenting Bone Marrow With CD34 Enriched Peripheral Blood Hematopoietic Stem Cells for Allogeneic Transplantation of Hematologic Malignancies |
| Study Start Date: | October 1999 |
| Study Completion Date: | October 2002 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients undergo allogeneic transplantation comprising unmanipulated bone marrow with filgrastim (G-CSF)-mobilized, CD34+ enriched peripheral blood stem cells on day 0.
Patients receive graft-vs-host disease prophylaxis comprising cyclosporine IV over 24 hours on day -1 and methylprednisolone IV or oral prednisone daily on days 7-65. Patients also receive G-CSF subcutaneously daily until blood counts recover.
Patients are followed weekly for 3 months, at 6 months and 1 year, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 10 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Study Chair: | Richard K. Burt, MD | Robert H. Lurie Cancer Center |
More Information
| Responsible Party: | Richard Burt, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004232 History of Changes |
| Other Study ID Numbers: | NU FDA96H4, NU-96H4, NCI-G99-1660 |
| Study First Received: | January 28, 2000 |
| Last Updated: | February 16, 2011 |
| Health Authority: | United States: Federal Government |
|
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma monoclonal gammopathy of undetermined significance recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma Burkitt lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma |
refractory multiple myeloma stage 0 chronic lymphocytic leukemia stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia |
|
Neoplasms Disease Graft vs Host Disease Leukemia Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Precancerous Conditions Lymphoma, Large-Cell, Immunoblastic Pathologic Processes |
Immune System Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Cyclosporins Cyclosporine |
