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

Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer

Phase 1

Completed

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

Interventions: Biological: anti-thymocyte globulin
Biological: sargramostim
Drug: busulfan
Drug: etoposide
Drug: fludarabine phosphate
Drug: prednisone
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: umbilical cord blood transplantation

First Posted Date: 2006-03-17

Last Posted Date: 2013-08-14

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 5

Registration Number: NCT00304018

Locations: 🇺🇸
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

Busulfan and Fludarabine Before Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

Phase 2

Withdrawn

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

First Posted Date: 2006-03-13

Last Posted Date: 2012-10-02

Lead Sponsor: University of California, San Francisco

Registration Number: NCT00301912

Locations: 🇺🇸
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

Alemtuzumab, Fludarabine, and Busulfan Followed By Donor Stem Cell Transplant in Treating Young Patients With Hematologic Disorders

Phase 2

Completed

Conditions: Congenital Amegakaryocytic Thrombocytopenia
Severe Congenital Neutropenia
Diamond-blackfan Anemia
Leukemia
Myelodysplastic Syndromes

Interventions: Biological: alemtuzumab
Drug: busulfan
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: methotrexate
Drug: methylprednisolone
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Procedure: umbilical cord blood transplantation

First Posted Date: 2006-03-13

Last Posted Date: 2017-09-28

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 35

Registration Number: NCT00301834

Locations: 🇺🇸
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
🇺🇸
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

Low-Dose Fludarabine, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer

Phase 1

Completed

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

Interventions: Biological: anti-thymocyte globulin
Biological: sargramostim
Drug: busulfan
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: umbilical cord blood transplantation

First Posted Date: 2006-03-13

Last Posted Date: 2017-10-12

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 7

Registration Number: NCT00301951

Locations: 🇺🇸
UCSF Comprehensive Cancer Center, San Francisco, California, United States

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia

Not Applicable

Conditions: Chronic Myeloproliferative Disorders
Kidney Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms

First Posted Date: 2006-02-24

Last Posted Date: 2014-01-06

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 35

Registration Number: NCT00295997

Locations: 🇺🇸
UCSF Comprehensive Cancer Center, San Francisco, California, United States
🇺🇸
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Donor Stem Cell Transplant in Treating Older or Frail Patients With Hematologic Cancer

Not Applicable

Completed

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

Interventions: Biological: anti-thymocyte globulin
Biological: filgrastim
Biological: therapeutic allogeneic lymphocytes
Drug: busulfan
Drug: fludarabine phosphate
Drug: methotrexate
Drug: tacrolimus
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2006-02-24

Last Posted Date: 2012-10-04

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 25

Registration Number: NCT00296023

Locations: 🇺🇸
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
🇺🇸
UCSF Comprehensive Cancer Center, San Francisco, California, United States

Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer

Not Applicable

Terminated

Conditions: Chronic Myeloproliferative Disorders
Diamond-blackfan Anemia
Fanconi Anemia
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

First Posted Date: 2006-02-13

Last Posted Date: 2017-11-29

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 43

Registration Number: NCT00290628

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

Fludarabine and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Chronic Lymphocytic Leukemia or Waldenstrom's Macroglobulinemia

Phase 1

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Biological: alemtuzumab
Biological: anti-thymocyte globulin
Biological: filgrastim
Biological: rituximab
Biological: therapeutic allogeneic lymphocytes
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: methotrexate
Drug: mycophenolate mofetil
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy

First Posted Date: 2006-01-25

Last Posted Date: 2017-07-24

Lead Sponsor: German CLL Study Group

Target Recruit Count: 100

Registration Number: NCT00281983

Locations: 🇩🇪
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, Germany
🇩🇪
University Hospital of Leipzig, Leipzig, Germany
🇩🇪
Klinikum der Universitaet Regensburg, Regensburg, Germany

and more 10 locations

Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer

Phase 2

Terminated

Conditions: Unusual Cancers of Childhood
Chronic Myeloproliferative Disorders
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Leukemia
Lymphoma

Interventions: Biological: filgrastim
Biological: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: busulfan
Drug: carmustine
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: methotrexate
Drug: cytarabine
Drug: mycophenolate mofetil
Drug: etoposide
Drug: methylprednisolone
Drug: tacrolimus
Drug: melphalan
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Procedure: umbilical cord blood transplantation

First Posted Date: 2006-01-25

Last Posted Date: 2017-09-27

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 200

Registration Number: NCT00281879

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Biological: filgrastim
Drug: busulfan
Drug: cyclophosphamide
Drug: etoposide
Drug: melphalan
Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
Radiation: radiation therapy

First Posted Date: 2005-12-15

Last Posted Date: 2013-11-20

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 42

Registration Number: NCT00265889

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

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy