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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborators: |
M.D. Anderson Cancer Center Fred Hutchinson Cancer Research Center Otsuka Pharmaceutical Co., Ltd. |
| Information provided by (Responsible Party): | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00809276 |
Purpose
The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Multiple Myeloma Leukemia Myelodysplastic Syndrome |
Drug: Busulfan, Fludarabine, Cytoxan |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 95 |
| Study Start Date: | May 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 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
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00809276 History of Changes |
| Other Study ID Numbers: | J0844, NA_00017193 |
| Study First Received: | December 16, 2008 |
| Last Updated: | January 27, 2012 |
| 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 |
Hematologic Malignancies Transplantation Busulfan Fludarabine Cytoxan Bone Marrow Allogeneic Related donor unrelated donor |
|
Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Hematologic Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases |
Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Neoplasms by Site Busulfan Cyclophosphamide Fludarabine monophosphate Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |