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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center M.D. Anderson Cancer Center Fred Hutchinson Cancer Research Center Otsuka Pharmaceutical Co., Ltd. |
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Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00809276 |
The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
Condition | Intervention | Phase |
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Lymphoma Multiple Myeloma Leukemia Myelodysplastic Syndrome |
Drug: Busulfan, Fludarabine, Cytoxan |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-Matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-Transplant Conditioning Followed by Post-Transplant Immunosuppression With High-Dose Cyclophosphamide |
Estimated Enrollment: | 90 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2020 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Busulfan once a day for 4 days
Fludarabine once a day for 4 days
Bone marrow transplant
Cytoxan two doses
A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)
However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Acute myeloid leukemia (AML) in CR1 with high risk features defined as:
i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities]
Exclusion Criteria:
United States, Maryland | |
The Sydney Kimmel Comprehensive Cancer center | |
Baltimore, Maryland, United States, 21231 | |
United States, Texas | |
Marcos deLima, MD | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Paul V. O'Donnell, M.D., Ph.D. | |
Seattle, Washington, United States, 98109 |
Study Chair: | Leo Luznik, MD | Johns Hopkins University |
Responsible Party: | Sydney Kimmel Comprehensive Cancer center ( Leo Luznik, MD ) |
Study ID Numbers: | J0844, JHM IRB # NA_00017193 |
Study First Received: | December 16, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00809276 |
Health Authority: | United States: Institutional Review Board |
Acute lymphocytic leukemia (ALL) Acute myeloid leukemia (AML) Acute Leukemia Refractory or Relapsed AML Myelodysplastic syndrome (MDS) Chronic myeloid leukemia (CML) Chronic myelomonocytic leukemia Hodgkin's Lymphoma Non-Hodgkin's lymphoma Philadelphia-negative myeloproliferative disorder |
Hemetologic Malignancies Transplantation Busulfan Flidaeabine Cytoxan Bone Marrow Allogeneic Related donor unrelated donor |
Leukemia, Lymphoid Hodgkin's disease Chronic myelogenous leukemia Precancerous Conditions Chronic myelomonocytic leukemia Blood Protein Disorders Lymphoma, small cleaved-cell, diffuse Paraproteinemias Cyclophosphamide Leukemia, Myeloid, Acute Hemostatic Disorders Leukemia Preleukemia Hemorrhagic Disorders Multiple myeloma |
Acute myelocytic leukemia Hodgkin Disease Lymphoma Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia Myeloproliferative Disorders Vascular Diseases Fludarabine monophosphate |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Pathologic Processes Therapeutic Uses Syndrome Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |