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

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

Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia

Phase 1

Completed

Conditions: Leukemia

Interventions: Biological: Filgrastim
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Cyclosporine
Drug: Decitabine (DAC)
Drug: Methotrexate
Drug: Methylprednisolone
Drug: Tacrolimus
Procedure: Allogeneic Bone Marrow Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation

First Posted Date: 2004-07-29

Last Posted Date: 2018-10-26

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 24

Registration Number: NCT00002831

Locations: 🇺🇸
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Acute Myelogenous Leukemia

Phase 3

Conditions: Leukemia

First Posted Date: 2004-07-19

Last Posted Date: 2009-12-23

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 1520

Registration Number: NCT00002549

Locations: 🇵🇹
Hospitais da Universidade de Coimbra (HUC), Coimbra, Portugal
🇨🇿
Institute of Hematology and Blood Transfusion, Prague, Czech Republic
🇧🇪
Algemeen Ziekenhuis Middelheim, Antwerp, Belgium

and more 72 locations

Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Leukemia or Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Lymphoma
Myelodysplastic Syndromes
Multiple Myeloma and Plasma Cell Neoplasm
Leukemia

First Posted Date: 2004-07-19

Last Posted Date: 2013-06-27

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00002502

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant Diseases

Phase 2

Conditions: Lymphoma
Fanconi Anemia
Myelodysplastic Syndromes
Sarcoma
Leukemia
Childhood Langerhans Cell Histiocytosis
Neuroblastoma
Unspecified Childhood Solid Tumor, Protocol Specific

Interventions: Biological: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: busulfan
Radiation: radiation therapy
Drug: melphalan
Drug: fludarabine phosphate
Drug: methylprednisolone

First Posted Date: 2004-06-11

Last Posted Date: 2014-01-10

Lead Sponsor: Milton S. Hershey Medical Center

Target Recruit Count: 25

Registration Number: NCT00084695

Locations: 🇺🇸
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Removal of T Cells to Prevent Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation

Phase 2

Terminated

Conditions: Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes

First Posted Date: 2004-06-08

Last Posted Date: 2012-12-11

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Registration Number: NCT00005641

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Chemotherapy and Bone Marrow Transplantation in Treating Patients Acute Myeloid With Leukemia or Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Leukemia
Myelodysplastic Syndromes

First Posted Date: 2004-05-24

Last Posted Date: 2012-08-07

Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Target Recruit Count: 280

Registration Number: NCT00002547

Locations: 🇺🇸
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Total-Body Irradiation, Busulfan, and Interferon Alfa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

First Posted Date: 2004-05-24

Last Posted Date: 2011-11-17

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT00003195

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

Combination Chemotherapy and Bone Marrow Transplantation or Peripheral Stem Cell Transplantation in Treating Patients With Oligodendroglioma

Phase 2

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2004-05-21

Last Posted Date: 2013-06-25

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 60

Registration Number: NCT00003101

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States
🇺🇸
Evanston Northwestern Health Care, Evanston, Illinois, United States

and more 4 locations

Chemotherapy With or Without Total-Body Irradiation Prior to Bone Marrow Transplantation in Treating Children With Acute Lymphoblastic Leukemia

Phase 3

Terminated

Conditions: Leukemia

Interventions: Drug: cyclophosphamide
Drug: etoposide
Drug: cyclosporine
Procedure: allogeneic bone marrow transplantation
Radiation: Total Body Irradiation
Drug: methotrexate
Radiation: Radiation
Drug: Busulfan
Drug: Mesna

First Posted Date: 2004-05-19

Last Posted Date: 2013-10-16

Lead Sponsor: Children's Hospital of Philadelphia

Target Recruit Count: 43

Registration Number: NCT00002961

Locations: 🇺🇸
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States
🇺🇸
Nemours Children's Clinic, Jacksonville, Florida, United States
🇺🇸
Children's Mercy Hospital, Kansas City, Missouri, United States

and more 15 locations

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage II or Stage IIIA Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer

First Posted Date: 2004-05-03

Last Posted Date: 2010-04-02

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 280

Registration Number: NCT00003972

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

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