Busulfan

Generic Name: Busulfan

Brand Names: Busulfex, Myleran, Busulfan Fresenius Kabi

Drug Type: Small Molecule

Chemical Formula: C_₆H_₁₄O_₆S_₂

CAS Number: 55-98-1

Unique Ingredient Identifier: G1LN9045DK

Advanced Drug Monograph

Access comprehensive pharmacological analysis, clinical applications, and therapeutic considerations.

Background: Busulfan is a bifunctional alkylating agent, having a selective immunosuppressive effect on bone marrow. It is not a structural analog of the nitrogen mustards. It has been used in the palliative treatment of chronic myeloid leukemia (myeloid leukemia, chronic), but although symptomatic relief is provided, no permanent remission is brought about. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), busulfan is listed as a known carcinogen.

Indication: For use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia (FDA has designated busulfan as an orphan drug for this use). It is also used as a component of pretransplant conditioning regimens in patients undergoing bone marrow transplantation for acute myeloid leukemia and nonmalignant diseases.

Associated Conditions: Chronic Myelogenous Leukemia (CML), Essential Thrombocythemia (ET), Polycythemia Vera (PV)

Associated Therapies: Conditioning regimens for allogeneic stem cell transplantation therapy

Clinical Trials

Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer

Phase 2

Completed

Conditions: Leukemia
Lymphoma
Multiple Myeloma
Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myeloproliferative Neoplasms

Interventions: Biological: anti-thymocyte globulin
Biological: G-CSF
Drug: busulfan
Drug: fludarabine phosphate
Drug: methotrexate
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: allogeneic cell transplantation
Drug: allopurinol

First Posted Date: 2003-01-28

Last Posted Date: 2016-07-01

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 82

Registration Number: NCT00053196

Locations: 🇺🇸
Union Hospital Cancer Center at Union Hospital, Elkton MD, Maryland, United States
🇺🇸
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
🇺🇸
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees, Voorhees, New Jersey, United States

and more 9 locations

Chemotherapy, Interferon, and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia

Phase 3

Conditions: Leukemia

First Posted Date: 2003-01-27

Last Posted Date: 2013-08-02

Lead Sponsor: German CML Study Group

Target Recruit Count: 750

Registration Number: NCT00002771

Locations: 🇩🇪
III Medizinische Klinik Mannheim, Mannheim, Germany

Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer

Phase 2

Completed

Conditions: Graft Versus Host Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

First Posted Date: 2003-01-27

Last Posted Date: 2012-03-15

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 44

Registration Number: NCT00003335

Locations: 🇺🇸
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer

Phase 2

Completed

Conditions: Unspecified Childhood Solid Tumor, Protocol Specific
Chronic Myeloproliferative Disorders
Leukemia
Myelodysplastic Syndromes
Nonmalignant Neoplasm
Unspecified Adult Solid Tumor, Protocol Specific
Lymphoma
Myelodysplastic/Myeloproliferative Diseases

Interventions: Biological: anti-thymocyte globulin
Drug: busulfan
Drug: fludarabine phosphate
Drug: carboplatin
Radiation: total-body irradiation
Drug: cyclophosphamide
Drug: melphalan
Drug: etoposide
Drug: thiotepa

First Posted Date: 2003-01-27

Last Posted Date: 2021-08-13

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 361

Registration Number: NCT00003816

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma

Phase 3

Conditions: Sarcoma

Interventions: Biological: dactinomycin
Drug: doxorubicin hydrochloride
Drug: busulfan
Drug: etoposide
Drug: ifosfamide
Drug: vincristine sulfate
Procedure: conventional surgery
Drug: melphalan
Radiation: radiation therapy
Procedure: autologous hematopoietic stem cell transplantation

First Posted Date: 2003-01-27

Last Posted Date: 2014-06-24

Lead Sponsor: University of Leicester

Target Recruit Count: 1200

Registration Number: NCT00020566

Locations: 🇺🇸
University of Chicago Cancer Research Center, Chicago, Illinois, United States
🇺🇸
Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States
🇺🇸
West Virginia University Health Sciences Center - Charleston, Charleston, West Virginia, United States

and more 100 locations

Combination Chemotherapy With or Without Filgrastim Before Surgery, High-Dose Chemotherapy, and Radiation Therapy Followed by Isotretinoin With or Without Monoclonal Antibody in Treating Patients With Neuroblastoma

Phase 3

Conditions: Neuroblastoma

First Posted Date: 2003-01-27

Last Posted Date: 2014-06-24

Lead Sponsor: University of Leicester

Target Recruit Count: 175

Registration Number: NCT00030719

Locations: 🇧🇪
Universitair Ziekenhuis Gent, Ghent, Belgium
🇳🇴
Rikshospitalet University Hospital, Oslo, Norway
🇬🇧
Birmingham Children's Hospital, Birmingham, England, United Kingdom

and more 28 locations

Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma

Phase 2

Completed

Conditions: Lymphoma

First Posted Date: 2003-01-27

Last Posted Date: 2016-02-03

Lead Sponsor: AIDS Malignancy Consortium

Registration Number: NCT00005824

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders

Phase 2

Completed

Conditions: Chronic Myeloproliferative Disorders
Leukemia
Myelodysplastic/Myeloproliferative Diseases

First Posted Date: 2003-01-27

Last Posted Date: 2010-04-02

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 20

Registration Number: NCT00002792

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Combination Chemotherapy, Bone Marrow or Peripheral Stem Cell Transplantation, and/or Biological Therapy in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Lymphoma

First Posted Date: 2003-01-27

Last Posted Date: 2012-06-06

Lead Sponsor: Northwestern University

Registration Number: NCT00004231

Locations: 🇺🇸
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

First Posted Date: 2003-01-27

Last Posted Date: 2012-06-12

Lead Sponsor: Northwestern University

Registration Number: NCT00004899

Locations: 🇺🇸
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

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