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, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Drug: busulfan
Drug: cyclophosphamide
Procedure: autologous hematopoietic stem cell transplantation

First Posted Date: 2009-07-20

Last Posted Date: 2020-07-24

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 71

Registration Number: NCT00941720

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Busulfan in Multiple Myeloma

Phase 1

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Busulfan

First Posted Date: 2009-07-08

Last Posted Date: 2017-05-23

Lead Sponsor: Guido Tricot

Target Recruit Count: 13

Registration Number: NCT00934232

Pilot Study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients With Poor Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukaemia (AML) Utilising Conditioning With Fludarabine, Busulphan and Thymoglobulin

Phase 2

Terminated

Conditions: Myelodysplastic Syndromes
Leukemia, Myeloid, Acute

Interventions: Drug: Fludarabine
Drug: Busulphan
Drug: Thymoglobuline (Anti-thymocyte globulin [rabbit]) - Genzyme
Procedure: Haematopoietic stem cell infusion

First Posted Date: 2009-06-08

Last Posted Date: 2011-08-17

Lead Sponsor: King's College Hospital NHS Trust

Target Recruit Count: 20

Registration Number: NCT00915811

Locations: 🇬🇧
King's College Hospital NHS Foundation Trust, London, United Kingdom

Allogeneic Stem Cell Transplantation (ALLOSCT) in Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Early Phase 1

Terminated

Conditions: Epidermolysis Bullosa

Interventions: Drug: Palifermin
Drug: Fludarabine
Drug: Busulfan
Drug: Lorazepam
Drug: Alemtuzumab
Drug: Tacrolimus

First Posted Date: 2009-04-15

Last Posted Date: 2021-08-17

Lead Sponsor: Columbia University

Target Recruit Count: 3

Registration Number: NCT00881556

Locations: 🇺🇸
The Children's Hospital, Aurora, Colorado, United States
🇺🇸
Morgan Stanley Children's Hospital of NYP, New York, New York, United States
🇺🇸
Children's Memorial Hospital, Chicago, Illinois, United States

Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory High-Risk NBL.

Phase 2

Withdrawn

Conditions: Neuroblastoma

First Posted Date: 2009-04-02

Last Posted Date: 2015-10-16

Lead Sponsor: Nationwide Children's Hospital

Registration Number: NCT00874315

Locations: 🇺🇸
Children's Memorial Hospital, Chicago, Illinois, United States
🇺🇸
Children's Hopsital of Wisconsin, Milwaukee, Wisconsin, United States
🇺🇸
Morgan Stanley Children's Hospital of NY, New York, New York, United States

and more 1 locations

Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies

Phase 2

Completed

Conditions: Leukemia
Lymphoma
Stem Cell Transplantation

Interventions: Drug: Thiotepa
Drug: Clofarabine
Drug: Busulfan
Procedure: Allogeneic Stem Cell Transplantation
Drug: Thymoglobulin (ATG)
Drug: G-CSF (Filgrastim)
Drug: Tacrolimus
Drug: Methotrexate
Drug: Cyclophosphamide
Drug: Mesna

First Posted Date: 2009-03-06

Last Posted Date: 2020-04-07

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 60

Registration Number: NCT00857389

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

Laromustine, Daunorubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Leukemia

First Posted Date: 2009-02-10

Last Posted Date: 2011-05-13

Lead Sponsor: Institut Paoli-Calmettes

Target Recruit Count: 135

Registration Number: NCT00840684

Locations: 🇫🇷
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes, Marseille, France

Study of Busulfan for Refractory Central Nervous System (CNS) Tumors

Phase 1

Withdrawn

Conditions: Refractory Brain Tumors

Interventions: Drug: Busulfan

First Posted Date: 2009-02-04

Last Posted Date: 2020-08-05

Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Registration Number: NCT00836628

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin

Phase 1

Completed

Conditions: Stem Cell Transplantation
Leukemia

Interventions: Drug: Plerixafor
Drug: Filgrastim
Drug: Fludarabine
Drug: Busulfan
Procedure: Allogeneic blood stem cell transplant
Drug: ATG (Thymoglobulin)

First Posted Date: 2009-01-14

Last Posted Date: 2020-10-14

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 47

Registration Number: NCT00822770

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC)

Phase 3

Completed

Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome

Interventions: Drug: Busulfan
Drug: Treosulfan

First Posted Date: 2009-01-14

Last Posted Date: 2020-07-30

Lead Sponsor: medac GmbH

Target Recruit Count: 570

Registration Number: NCT00822393

Locations: 🇮🇹
Ospedale Civile Pescara, Pescara, Italy
🇩🇪
Universitätsklinikum Freiburg, Freiburg, Germany
🇩🇪
Klinikum Nürnberg, 5. Medizinische Klinik, Nürnberg, Germany

and more 30 locations

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