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

Combination Chemotherapy With or Without PSC 833, Peripheral Stem Cell Transplantation, and/or Interleukin-2 in Treating Patients With Acute Myeloid Leukemia

Phase 3

Completed

Conditions: Adult Acute Eosinophilic Leukemia
Adult Acute Erythroid Leukemia (M6)
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Basophilic Leukemia
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)

Interventions: Drug: cytarabine
Biological: aldesleukin
Other: clinical observation
Drug: daunorubicin hydrochloride
Biological: filgrastim
Drug: etoposide
Other: pharmacological study
Drug: valspodar
Drug: busulfan
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 720

Registration Number: NCT00006363

Locations: 🇺🇸
Cancer and Leukemia Group B, Chicago, Illinois, United States

Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer

Phase 2

Completed

Conditions: Estrogen Receptor-negative Breast Cancer
Male Breast Cancer
Estrogen Receptor-positive Breast Cancer
Progesterone Receptor-negative Breast Cancer
Inflammatory Breast Cancer
Progesterone Receptor-positive Breast Cancer
Stage IIIB Breast Cancer
Stage IV Breast Cancer

Interventions: Drug: tamoxifen citrate
Drug: busulfan
Drug: thiotepa
Drug: melphalan
Biological: aldesleukin
Biological: sargramostim
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy

First Posted Date: 2003-01-27

Last Posted Date: 2017-07-12

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 50

Registration Number: NCT00003199

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/Puget Sound Oncology Consortium, Seattle, Washington, United States

Chemotherapy and Surgery Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Neuroblastoma

Phase 2

Conditions: Neuroblastoma

First Posted Date: 2003-01-27

Last Posted Date: 2013-08-07

Lead Sponsor: Children's Cancer and Leukaemia Group

Registration Number: NCT00024193

Locations: 🇫🇷
Institut Gustave Roussy, Villejuif, France

Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Biological: filgrastim
Biological: recombinant interferon alfa
Drug: busulfan
Drug: cyclophosphamide
Drug: melphalan
Drug: pamidronate disodium
Drug: thalidomide
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2003-01-27

Last Posted Date: 2019-07-02

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 77

Registration Number: NCT00004088

Locations: 🇺🇸
Banner Good Samaritan Medical Center, Phoenix, Arizona, United States
🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States

Combination Chemotherapy Followed by Surgery and Peripheral Stem Cell or Bone Marrow Transplantation in Treating Infants With Newly Diagnosed Neuroblastoma

Phase 2

Completed

Conditions: Neuroblastoma

First Posted Date: 2003-01-27

Last Posted Date: 2013-09-17

Lead Sponsor: European Infant Neuroblastoma Study Group - 1999

Registration Number: NCT00025649

Locations: 🇸🇪
Ostra Sjukhuset, Gothenburg, Sweden
🇫🇷
Centre Hospitalier Regional de Purpan, Toulouse, France
🇳🇴
Rikshospitalet University Hospital, Oslo, Norway

and more 8 locations

Chemotherapy and Biological Therapy With or Without Bone Marrow or Peripheral Stem Cell Transplant in Treating Patients With Chronic Myelogenous Leukemia

Phase 3

Conditions: Leukemia

First Posted Date: 2003-01-27

Last Posted Date: 2013-12-18

Lead Sponsor: III. Medizinische Klinik Mannheim

Target Recruit Count: 1000

Registration Number: NCT00025402

Locations: 🇩🇪
Tumorzentrum Berlin-Moabit, Berlin, Germany
🇩🇪
Wenckebach - Krankenhaus, Berlin, Germany
🇩🇪
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie, Ansbach, Germany

and more 175 locations

Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer

Phase 2

Completed

Conditions: Graft Versus Host Disease
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms

First Posted Date: 2003-01-27

Last Posted Date: 2013-03-07

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00014469

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

Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2003-01-27

Last Posted Date: 2013-02-20

Lead Sponsor: Duke University

Target Recruit Count: 20

Registration Number: NCT00003462

Locations: 🇺🇸
Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Combination Chemotherapy, Interleukin-2, and Peripheral Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia

Phase 3

Conditions: Leukemia

First Posted Date: 2003-01-27

Last Posted Date: 2009-12-23

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

Target Recruit Count: 2000

Registration Number: NCT00004128

Busulfan in Treating Children and Adolescents With Refractory CNS Cancer

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Leukemia
Lymphoma
Metastatic Cancer
Retinoblastoma
Sarcoma

First Posted Date: 2003-01-27

Last Posted Date: 2009-10-07

Lead Sponsor: Pediatric Brain Tumor Consortium

Target Recruit Count: 28

Registration Number: NCT00006246

Locations: 🇺🇸
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States
🇺🇸
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

and more 5 locations

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