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

Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)

Phase 4

Completed

Conditions: Myelodysplastic Syndromes
Myeloproliferative Disorders
Leukemia, Lymphocytic
Myeloma
Lymphoma

Interventions: Drug: Busulfan
Drug: Fludarabine

First Posted Date: 2006-08-07

Last Posted Date: 2017-03-03

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

Target Recruit Count: 72

Registration Number: NCT00361140

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

Busulfan, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk Ewing's Tumors

Phase 2

Completed

Conditions: Sarcoma

Interventions: Biological: graft versus host disease prophylaxis/therapy
Drug: busulfan
Drug: melphalan
Drug: thiotepa
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2006-07-27

Last Posted Date: 2015-11-25

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 10

Registration Number: NCT00357396

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

Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia

Phase 2

Active, not recruiting

Conditions: Recurrent Childhood Acute Myeloid Leukemia
Refractory Anemia With Excess Blasts in Transformation
Refractory Anemia
De Novo Myelodysplastic Syndrome
Secondary Myelodysplastic Syndrome
Childhood Myelodysplastic Syndrome
Leukemia
Myelodysplastic Syndromes
Secondary Acute Myeloid Leukemia
Refractory Anemia With Excess Blasts

Interventions: Biological: filgrastim
Drug: busulfan
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: melphalan
Drug: mycophenolate mofetil
Procedure: umbilical cord blood transplantation

First Posted Date: 2006-07-27

Last Posted Date: 2024-08-22

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 33

Registration Number: NCT00357565

Locations: 🇺🇸
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States

Fludarabine and Busulfan Followed by Donor Peripheral Stem Cell Transplant and Antithymocyte Globulin, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Cancer

Phase 2

Completed

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

First Posted Date: 2006-06-29

Last Posted Date: 2010-05-14

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 40

Registration Number: NCT00346359

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

Combination Chemotherapy Followed By Donor Stem Cell Transplant in Treating Patients With Hemophagocytic Lymphohistiocytosis

Phase 3

Conditions: Nonneoplastic Condition

First Posted Date: 2006-06-08

Last Posted Date: 2013-09-17

Lead Sponsor: Children's Cancer and Leukaemia Group

Target Recruit Count: 288

Registration Number: NCT00334672

Locations: 🇬🇧
Birmingham Children's Hospital, Birmingham, England, United Kingdom
🇬🇧
Watford General Hospital, Herts, England, United Kingdom
🇬🇧
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

and more 9 locations

Respiratory Side Effects of Busulfan High Dose Chemotherapy in a Pediatric Population

Phase 2

Conditions: Signs and Symptoms, Respiratory

First Posted Date: 2006-05-19

Last Posted Date: 2009-02-25

Lead Sponsor: University Hospital, Strasbourg, France

Target Recruit Count: 35

Registration Number: NCT00328029

Locations: 🇫🇷
Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre, Strasbourg, France
🇫🇷
Service d'Explorations Fonctionelles Respiratoires - Hôpital Civil, Strasbourg, France

Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia

Phase 3

Completed

Conditions: Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Myelodysplastic Syndrome With Isolated Del(5q)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Previously Treated Myelodysplastic Syndromes
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Acute Myeloid Leukemia/Transient Myeloproliferative Disorder
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)

Interventions: Radiation: total-body irradiation
Procedure: allogeneic hematopoietic stem cell transplantation
Drug: mycophenolate mofetil
Drug: cyclophosphamide
Drug: cyclosporine
Drug: busulfan
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
Genetic: cytogenetic analysis
Other: flow cytometry
Other: pharmacological study
Genetic: fluorescence in situ hybridization
Drug: tacrolimus
Genetic: polymorphism analysis
Drug: methotrexate

First Posted Date: 2006-05-04

Last Posted Date: 2014-10-31

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 25

Registration Number: NCT00322101

Locations: 🇺🇸
Weill Cornell University, New York, New York, United States
🇺🇸
HealthOne Presbyterian St. Lukes Medical Center, Denver, Colorado, United States
🇺🇸
Emory University, Altanta, Georgia, United States

and more 5 locations

Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma

Not Applicable

Conditions: Lymphoma

First Posted Date: 2006-04-24

Last Posted Date: 2015-09-25

Lead Sponsor: European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma

Target Recruit Count: 96

Registration Number: NCT00317408

Locations: 🇨🇿
University Hospital Brno, Brno, Czech Republic
🇧🇪
U.Z. Gasthuisberg, Leuven, Belgium
🇩🇪
Krankenhaus Muenchen Schwabing, Munich, Germany

and more 91 locations