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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR BUSULFEX

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Clinical Trials for Busulfex

Trial ID Title Status Sponsor Phase Summary
NCT00014469 Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer Completed National Cancer Institute (NCI) Phase 2 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of busulfan and melphalan followed by donor bone marrow transplantation in treating patients who have advanced hematologic cancer.
NCT00014469 Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer Completed Memorial Sloan Kettering Cancer Center Phase 2 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of busulfan and melphalan followed by donor bone marrow transplantation in treating patients who have advanced hematologic cancer.
NCT00113919 UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients Terminated University of Arkansas Phase 1/Phase 2 The purpose of this study is to find out if patients with high risk disease because of age or kidney status can be treated more safely with a drug called Busulfex® followed by autologous transplant compared to treatment with the standard drug called melphalan, which has been shown to be quite difficult to tolerate in patients with poor kidney function and patients over the age of 65 when given in high doses.
NCT00130754 Thymoglobuline in Non-myeloablative Allogeneic Stem-cell Transplantation Completed Hadassah Medical Organization Phase 3 Allogeneic stem cell transplantation is the treatment of choice for a growing number of malignant and non-malignant indications. Until recently, myeloablative in conjunction with immunosuppressive conditioning was considered mandatory for the elimination of malignant hematopoietic cells and to prevent graft rejection. The aim of allogeneic non-myeloablative stem cell transplantation (NST) is to induce host-to-graft tolerance with fast and durable engraftment of donor stem cells, by means of conditioning, which is well-tolerated by patients. The rationale behind the NST strategy is to induce optimal graft-versus-leukemia (GVL) effects for the elimination of all malignant cells by alloreactive immunocompetent cells from a matched donor as an alternative to standard high-dose myeloablative chemo radiotherapy. The NST protocol is therefore mainly based on immunosuppression and thus contains fludarabine, low dose busulfan and anti-T-lymphocyte globulin (ATG). Thymoglobuline is a polyclonal rabbit antiserum specific for human T cells used in organ transplantation for induction of tolerance and rejection prevention and treatment. It was also used in stem-cell transplantation (SCT) for the same purposes (e.g. for generation of tolerance and rejection preclusion) as well as a treatment for graft-versus-host disease (GVHD). Data from myeloablative protocols suggest that ATG before SCT significantly reduces the risk for grade III-IV acute GVHD. This does not translate to a reduction in transplant-related mortality (TRM) because of the increased risk for infections and thus survival is unchanged. Extensive chronic GVHD was also significantly shown to be reduced in patients receiving ATG in the myeloablative setting. However, the role of ATG in the NST protocol was never evaluated in a prospective randomized trial. In view of the preliminary data suggesting of an additive effect of ATG in these circumstances we, the investigators at Hadassah Medical Organization, evaluate the effect of ATG in NST by a prospective randomized trial.
NCT00146614 Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation Completed Beth Israel Deaconess Medical Center Phase 2 The purpose of this study is to determine if the incidence of Graft vs. Host Disease (GVHD) after non-myeloablative transplantation can be reduced by using a combination of three immune suppressive medication; sirolimus, tacrolimus and methotrexate.
NCT00146614 Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation Completed Brigham and Women's Hospital Phase 2 The purpose of this study is to determine if the incidence of Graft vs. Host Disease (GVHD) after non-myeloablative transplantation can be reduced by using a combination of three immune suppressive medication; sirolimus, tacrolimus and methotrexate.
NCT00146614 Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation Completed Massachusetts General Hospital Phase 2 The purpose of this study is to determine if the incidence of Graft vs. Host Disease (GVHD) after non-myeloablative transplantation can be reduced by using a combination of three immune suppressive medication; sirolimus, tacrolimus and methotrexate.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Busulfex

Condition Name

Condition Name for Busulfex
Intervention Trials
Myelodysplastic Syndrome 7
Leukemia 6
Graft Versus Host Disease 5
Acute Myeloid Leukemia 4
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Condition MeSH

Condition MeSH for Busulfex
Intervention Trials
Leukemia 12
Preleukemia 10
Myelodysplastic Syndromes 10
Syndrome 9
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Clinical Trial Locations for Busulfex

Trials by Country

Trials by Country for Busulfex
Location Trials
United States 38
Korea, Republic of 2
Israel 2
China 1
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Trials by US State

Trials by US State for Busulfex
Location Trials
Texas 6
New York 6
Massachusetts 6
California 3
Washington 2
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Clinical Trial Progress for Busulfex

Clinical Trial Phase

Clinical Trial Phase for Busulfex
Clinical Trial Phase Trials
Phase 3 6
Phase 2/Phase 3 2
Phase 2 18
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Clinical Trial Status

Clinical Trial Status for Busulfex
Clinical Trial Phase Trials
Completed 13
Recruiting 11
Not yet recruiting 7
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Clinical Trial Sponsors for Busulfex

Sponsor Name

Sponsor Name for Busulfex
Sponsor Trials
National Cancer Institute (NCI) 9
Dana-Farber Cancer Institute 5
Brigham and Women's Hospital 4
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Sponsor Type

Sponsor Type for Busulfex
Sponsor Trials
Other 59
Industry 9
NIH 9
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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Farmers Insurance
Mallinckrodt
Federal Trade Commission
Queensland Health
Chinese Patent Office
Healthtrust
Express Scripts
US Department of Justice

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