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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center Amgen |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00636909 |
The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. We hope to decrease these side effects by decreasing the chemotherapy dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone marrow is not completely eliminated) and by using donated stem cells to treat cancer of the blood.
Condition | Intervention | Phase |
---|---|---|
AML ALL CML Chronic Phase, Accelerated Phase, or Blast Crisis CLL MDS RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA Aplastic Anemia Multiple Myeloma MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET) |
Drug: Cyclophosphamide Drug: fludarabine Drug: cyclosporine Drug: methotrexate Biological: G-CSF |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders |
Enrollment: | 25 |
Study Start Date: | July 1999 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Study treatment arm with G-CSF
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Drug: Cyclophosphamide
preparative cytoreduction
Drug: fludarabine
preparative cytoreduction
Drug: cyclosporine
immunosuppressive therapy
Drug: methotrexate
immunosuppressive therapy
Biological: G-CSF
foster engraftment
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Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria - Patient:
Inclusion Criteria - Donor:
Exclusion Criteria - Patient:
Exclusion Criteria - Donor:
Principal Investigator: | David F McDermott, MD | Beth Israel Deaconess Medical Center |
Study Director: | David E Avigan, MD | Beth Israel Deaconess Medical Center |
Responsible Party: | BIDMC ( David F. McDermott, MD ) |
Study ID Numbers: | 2001P002293, W-99-0234-FB |
Study First Received: | March 10, 2008 |
Last Updated: | March 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00636909 |
Health Authority: | United States: Food and Drug Administration |
AML ALL CML CLL MDS NHL HODGKIN'S LYMPHOMA APLASTIC ANEMIA MULTIPLE MYELOMA MYELOPROLIFERATIVE DISORDER ALLOGENEIC |
STEM CELL TRANSPLANT HEMATOLOGIC DISORDERS CYCLOPHOSPHAMIDE FLUDARABINE CYCLOSPORINE METHOTREXATE G-CSF GVHD ENGRAFTMENT CHIMERISM |
Blast Crisis Cyclosporine Hodgkin's disease Clotrimazole Blood Protein Disorders Miconazole Hodgkin lymphoma, adult Paraproteinemias Cyclophosphamide Hemostatic Disorders Cyclosporins Leukemia Hemorrhagic Disorders Multiple myeloma Anemia, Aplastic |
Methotrexate Hodgkin Disease Lymphoma Immunoproliferative Disorders Hematologic Diseases Blood Coagulation Disorders Tioconazole Anemia Myeloproliferative Disorders Vascular Diseases Fludarabine monophosphate Leukemia, Myeloid Multiple Myeloma Folic Acid Lymphatic Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Neoplastic Processes Pathologic Processes Therapeutic Uses Antifungal Agents Abortifacient Agents Cardiovascular Diseases Alkylating Agents |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Disease Immune System Diseases Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Cell Transformation, Neoplastic |