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Sponsored by: |
Emory University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00208923 |
Patients who have cancer of the bone marrow (leukemia) or lymph gland (lymphomas) are being asked to take part in this study. This study uses a new chemotherapy regimen and matched volunteer stem cell transplant to treat patients with cancers of this kind.
Condition | Intervention | Phase |
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Hematologic Malignancies |
Drug: Busulfan, Cyclophosphamide and Fludarabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Allogeneic Bone Marrow Transplantation With Matched Unrelated Donors for Patients With Hematologic Malignancies Using a Preparative Regimen of Busulfan, Cyclophosphamide, and Fludarabine |
Estimated Enrollment: | 55 |
Study Start Date: | July 1998 |
Estimated Study Completion Date: | July 2015 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Chemotherapy-only conditioning regimen comprising busulfan (Bu), cyclophosphamide (Cy) and fludarabine (FLUDARA) followed by an allogeneic stem cell transplant.
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Drug: Busulfan, Cyclophosphamide and Fludarabine
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Patients who have cancer of the bone marrow (leukemia) or lymph gland (lymphomas) are being asked to take part in this study. This study uses a new chemotherapy regimen and matched volunteer stem cell transplant to treat patients with cancers of this kind.
High dose chemotherapy, followed by a transplant of stem cells collected from either bone marrow (BMT) or peripheral blood of an HLA (tissue type) matched unrelated donor, offers a potential cure for several serious blood diseases including acute and chronic leukemia, myelodysplastic syndrome and lymphoma.
However, the success of allogeneic (unrelated volunteer matched donor) transplant is limited by treatment related illness, death, and relapse in patients with refractory (resistant) disease and/or advanced age (older than 40 years).
Patients being sought for this study do not have an HLA-matched relative to donate stem cell; however, through The National Marrow Donor Program or International Registries, an HLA-matched unrelated donor has been found to donate stem cells. Preliminary data shows that the outcome is comparable between bone marrow and peripheral blood stem cell transplantations, and donor preference will determine which type of cells the patient receives.
To carry out an unrelated transplant, a normal person with similar HLA type must be available to donate cells. The patient must be prepared to accept the donor cells by decreasing the body's immune systems. In addition, the malignant (cancerous) cells must be destroyed to allow growth and repopulation of healthy donor cells. This is usually done by giving total body irradiation and chemotherapy, which is associated with severe side effects in patients over age 40.
In other studies, it has been found that treating the patient with two anticancer drugs, Busulfan and Cyclophosphamide, without total body irradiation, is safe and sufficiently immunosuppressive. High dose Busulfan and Cyclophosphamide are frequently used in combination prior to matched related bone marrow transplant in case of acute leukemia, myelodysplastic syndrome (MDS), Hodgkin's disease (HD), and chronic myeloid leukemia (CML). Fludarabine (another anticancer drug) suppresses the immune system and has strong anticancer effect against chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL). Researchers are studying a new chemotherapy regimen that includes fludarabine, along with busulfan and cyclophosphamide, to provide more immunosuppression and anti-cancer effect without increasing the chemotherapy related toxicity in patients with CML, acute leukemia and MDS, CLL, NHL, and HD.
The purposes of this study are: 1) to decrease the side effects due to the chemotherapy used to treat the bone marrow; and 2) to increase the number of tumor cells killed. There will be up to 55 patients enrolled in this study at Emory University. The expected duration of each subject's participation in this study will be for two years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Emory Universtiy Winship Cancer Institute | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Amelia Langston, MD | Emory University Winship Cancer Institute |
Responsible Party: | Winship Cancer Institute ( Amelia Langston, MD ) |
Study ID Numbers: | 0709-1997 |
Study First Received: | September 13, 2005 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00208923 |
Health Authority: | United States: Institutional Review Board |
Hematologic Malignancies |
Hematologic Neoplasms Hematologic Diseases Busulfan |
Fludarabine Fludarabine monophosphate Cyclophosphamide |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |