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

Chemotherapy and Radiation Therapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory T-cell Lymphoma, Hodgkin's Lymphoma, or Non-Hodgkin's Lymphoma

Phase 1

Completed

Conditions: Lymphoma

First Posted Date: 2003-01-27

Last Posted Date: 2012-06-12

Lead Sponsor: Northwestern University

Registration Number: NCT00004907

Locations: 🇺🇸
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

Bone Marrow Transplantation in Treating Patients With Multiple Myeloma, Chronic Phase Chronic Myelogenous Leukemia, or Agnogenic Myeloid Metaplasia

Phase 2

Completed

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

First Posted Date: 2003-01-27

Last Posted Date: 2012-06-12

Lead Sponsor: Northwestern University

Registration Number: NCT00004181

Locations: 🇺🇸
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Phase 2

Completed

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

First Posted Date: 2003-01-27

Last Posted Date: 2010-06-11

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 66

Registration Number: NCT00003116

Locations: 🇺🇸
Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Pilot Study Of Unrelated UCB Transplant for Non-Malignant Hematologic Conditions

Phase 2

Completed

Conditions: Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

First Posted Date: 2003-01-27

Last Posted Date: 2010-06-11

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 6

Registration Number: NCT00003336

Locations: 🇺🇸
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Biological Therapy in Treating Patients With Solid Tumors or Lymphoma

Phase 2

Completed

Conditions: Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific

First Posted Date: 2003-01-27

Last Posted Date: 2010-05-14

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT00027937

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

Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Leukemia
Myelodysplastic Syndromes

First Posted Date: 2003-01-27

Last Posted Date: 2010-05-13

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT00024050

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

Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Nonmalignant Hematologic Disease

Phase 2

Completed

Conditions: Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Leukemia

First Posted Date: 2003-01-27

Last Posted Date: 2010-04-02

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 390

Registration Number: NCT00003913

Locations: 🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
🇺🇸
Children's Hospital of Orange County, Orange, California, United States

and more 20 locations

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia

Phase 2

Completed

Conditions: Leukemia

First Posted Date: 2003-01-27

Last Posted Date: 2013-02-04

Lead Sponsor: Herbert Irving Comprehensive Cancer Center

Registration Number: NCT00008190

Locations: 🇺🇸
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States

Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

First Posted Date: 2003-01-27

Last Posted Date: 2013-02-04

Lead Sponsor: Herbert Irving Comprehensive Cancer Center

Target Recruit Count: 75

Registration Number: NCT00007995

Locations: 🇺🇸
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States

Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Phase 3

Completed

Conditions: Childhood Acute Erythroleukemia (M6)
Childhood Acute Megakaryocytic Leukemia (M7)
Childhood Acute Monoblastic Leukemia (M5a)
Childhood Acute Monocytic Leukemia (M5b)
Childhood Acute Myeloblastic Leukemia With Maturation (M2)
Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
Childhood Acute Myelomonocytic Leukemia (M4)
Childhood Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes

Interventions: Drug: daunorubicin hydrochloride
Drug: asparaginase
Drug: therapeutic hydrocortisone
Radiation: 3-dimensional conformal radiation therapy
Drug: fludarabine phosphate
Procedure: allogeneic bone marrow transplantation
Biological: filgrastim
Drug: cytarabine
Drug: idarubicin
Drug: dexamethasone
Biological: aldesleukin
Drug: thioguanine
Drug: etoposide
Drug: methotrexate
Drug: cyclophosphamide
Drug: busulfan

First Posted Date: 2003-01-27

Last Posted Date: 2013-01-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 880

Registration Number: NCT00002798

Locations: 🇺🇸
Children's Oncology Group, Arcadia, California, United States

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