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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center Bayer |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00533923 |
Allogeneic stem cell transplantation may provide long-term remissions for some patients with hematological malignancies. However, allogeneic transplantation is associated with a significant risk of potentially life threatening complications due to the effects of chemotherapy and radiation on the body and the risks of serious infection. In addition, patients may develop a condition called Graft versus host disease that arises from an inflammatory reaction of the donor cells against the recipient's normal tissues. The risk of graft versus host disease is somewhat increased in patients who are receiving a transplant from an unrelated donor.
One approach to reduce the toxicity of allogeneic transplantation is a strategy call nonmyeloablative or "mini" transplants. In this approach, patients receive a lower dose of chemotherapy in an effort to limit treatment related side effects. Patients undergoing this kind of transplant remain at risk for graft versus host disease particularly if they receive a transplant from an unrelated donor. The purpose of this research study is to examine the ability of a drug called CAMPATH-1H to reduce the risk of graft versus host disease and make transplantation safer. CAMPATH-1H binds to and eliminates cells in the system such as T cells that can cause graft versus host disease (GvHD). As a result, earlier studies have shown that patients who receive CAMPATH-1H with an allogeneic transplant have a lower risk of GvHD. In the present study, we will examine the impact of treatment with CAMPATH-1H as part of an allogeneic transplant on the development of GvHD and infection. In addition, we will study the effects of CAMPATH-1H on the immune system by testing blood samples in the laboratory.
Condition | Intervention | Phase |
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AML ALL CLL Myelodysplastic Syndrome Non-Hodgkin's Lymphoma Hodgkin's Lymphoma Multiple Myeloma Aplastic Anemia Myeloproliferative Disorder |
Drug: Cyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H (Alemtuzumab); GM-CSF |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | Nonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic Disorders |
Estimated Enrollment: | 25 |
Study Start Date: | December 2002 |
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Eligibility Criteria - Donor
Exclusion Criteria:
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | David F McDermott, MD | Beth Israel Deaconess Medical Center |
Study Director: | David E Avigan, MD | Beth Israel Deaconess Medical Center |
Responsible Party: | Beth Israel Deaconess Medical Center ( David McDermott, MD ) |
Study ID Numbers: | 2002P000219 |
Study First Received: | September 20, 2007 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00533923 |
Health Authority: | United States: Institutional Review Board |
Nonmyeloablative Allogeneic Stem Cell Transplantation mini-transplant AML ALL CML CLL Myelodysplastic syndrome Relapsed non-Hodgkin's or Hodgkin's lymphoma Relapsed multiple myeloma Aplastic anemia Myeloproliferative disorder GM-CSF Cyclosporin |
Fludarabine (FLUDARA) Cyclophosphamide CAMPATH-1H GVHD CMV AML in first remission, first relapse or subsequent remission ALL in first relapse, second or subsequent remission ALL in first remission, in a high-risk category Relapsed non-Hodgkin's or Hodgkin's lymphoma Relapsed multiple myeloma Aplastic anemia characterized by ANC< 1000 and/or platelets < 30 without transfusional support Myeloproliferative disorder (P Vera, CMML, ET) |
Cyclosporine Hodgkin's disease Precancerous Conditions Clotrimazole Blood Protein Disorders Miconazole Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Paraproteinemias Cyclophosphamide Hemostatic Disorders Cyclosporins Preleukemia Hemorrhagic Disorders Multiple myeloma |
Alemtuzumab Anemia, Aplastic Hodgkin Disease Lymphoma Myelodysplastic syndromes Immunoproliferative Disorders Hematologic Diseases Blood Coagulation Disorders Myelodysplastic Syndromes Myelodysplasia Tioconazole Anemia Myeloproliferative Disorders Vascular Diseases Fludarabine monophosphate |
Anti-Infective Agents Disease Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Pathologic Processes Antifungal Agents Syndrome Therapeutic Uses Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents |