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

Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell Transplantation: a Pharmacokinetic Study

Not Applicable

Conditions: Hematologic Malignancy

First Posted Date: 2005-09-12

Last Posted Date: 2012-01-19

Lead Sponsor: Alberta Health services

Target Recruit Count: 200

Registration Number: NCT00156858

Locations: 🇨🇦
Tom Baker Cancer Centre, Calgary, Alberta, Canada

Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer

Phase 2

Completed

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

Interventions: Drug: Busulfan
Drug: Cyclophosphamide

First Posted Date: 2005-08-24

Last Posted Date: 2018-08-31

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 142

Registration Number: NCT00134017

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

UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients

Phase 1

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Busulfan

First Posted Date: 2005-06-13

Last Posted Date: 2017-10-16

Lead Sponsor: University of Arkansas

Target Recruit Count: 14

Registration Number: NCT00113919

Locations: 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
🇺🇸
University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy, Little Rock, Arkansas, United States

Donor Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory Solid Tumors

Phase 1

Completed

Conditions: Neuroblastoma
Sarcoma
Unspecified Childhood Solid Tumor, Protocol Specific

First Posted Date: 2005-06-03

Last Posted Date: 2013-07-18

Lead Sponsor: Milton S. Hershey Medical Center

Target Recruit Count: 10

Registration Number: NCT00112645

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

Antithymocyte Globulin and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Chemotherapy With or Without Radiation Therapy Followed By Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

Not Applicable

Conditions: Graft Versus Host Disease
Leukemia

First Posted Date: 2004-10-08

Last Posted Date: 2013-11-06

Lead Sponsor: Jonsson Comprehensive Cancer Center

Registration Number: NCT00093587

Locations: 🇺🇸
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States

Use of Busulfan as Conditioning Agent for a Second Stem Cell Transplant

Phase 1

Completed

Conditions: Granulomatous Disease
Chronic

First Posted Date: 2004-09-27

Last Posted Date: 2017-07-02

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 2

Registration Number: NCT00092937

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Monoclonal Antibody Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia in Remission or First Relapse

Phase 2

Completed

Conditions: Leukemia

First Posted Date: 2004-08-31

Last Posted Date: 2010-03-30

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 30

Registration Number: NCT00002554

Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer

Phase 2

Completed

Conditions: Graft Versus Host Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
Neuroblastoma

First Posted Date: 2004-08-04

Last Posted Date: 2011-03-07

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 3

Registration Number: NCT00003661

Locations: 🇺🇸
North Shore University Hospital, Manhasset, New York, United States
🇺🇸
Nemours Children's Clinic, Jacksonville, Florida, United States
🇺🇸
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States

and more 14 locations

Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Other Hematologic or Metabolic Diseases

Phase 2

Completed

Conditions: Graft Versus Host Disease
Leukemia
Myelodysplastic Syndromes
Thymic Carcinoma

First Posted Date: 2004-08-04

Last Posted Date: 2011-03-07

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 90

Registration Number: NCT00003662

Locations: 🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
🇺🇸
University of Florida Health Science Center, Gainesville, Florida, United States

and more 12 locations

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

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