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

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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, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Ewing's Sarcoma, Peripheral Primitive Neuroectodermal Tumor, or Rhabdomyosarcoma

Phase 1

Completed

Conditions: Sarcoma

First Posted Date: 2004-04-27

Last Posted Date: 2010-09-20

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 16

Registration Number: NCT00003081

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

Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia

Phase 1

Completed

Conditions: Chronic Myeloproliferative Disorders
Leukemia
Myelodysplastic Syndromes
Thrombocytopenia

First Posted Date: 2004-04-27

Last Posted Date: 2013-06-26

Lead Sponsor: Drexel University College of Medicine

Registration Number: NCT00003619

Locations: 🇺🇸
Medical College of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
Medical College of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States

Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer

Phase 2

Completed

Conditions: Myelodysplastic Syndromes
Multiple Myeloma and Plasma Cell Neoplasm
Graft Versus Host Disease
Leukemia
Lymphoma

Interventions: Biological: anti-thymocyte globulin
Biological: filgrastim
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: methylprednisolone
Procedure: bone marrow ablation with stem cell support
Procedure: umbilical cord blood transplantation
Radiation: radiation therapy

First Posted Date: 2004-04-27

Last Posted Date: 2019-12-13

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 20

Registration Number: NCT00003270

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

First Posted Date: 2004-04-23

Last Posted Date: 2011-06-23

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT00003146

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

Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission

Phase 2

Completed

Conditions: Leukemia

Interventions: Biological: filgrastim
Drug: busulfan
Drug: cytarabine
Drug: etoposide
Drug: methotrexate
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2004-04-22

Last Posted Date: 2016-06-28

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 51

Registration Number: NCT00002768

Locations: 🇺🇸
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
🇺🇸
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
🇺🇸
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States

OTI-010 for Graft-Versus-Host Disease Prophylaxis in Treating Patients Who Are Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies

Phase 2

Withdrawn

Conditions: Myelodysplastic Syndromes
Graft Versus Host Disease
Leukemia

First Posted Date: 2004-04-08

Last Posted Date: 2014-12-04

Lead Sponsor: Mesoblast International Sàrl

Registration Number: NCT00081055

Locations: 🇺🇸
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

Chemotherapy Followed by Peripheral Stem Cell Transplantation And Biological Therapy in Treating Patients With Chronic Myelogenous Leukemia

Phase 2

Completed

Conditions: Leukemia

First Posted Date: 2004-04-02

Last Posted Date: 2010-04-02

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT00005948

Locations: 🇺🇸
University of Colorado Cancer Center, Denver, Colorado, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Chemotherapy and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia

Phase 2

Completed

Conditions: Leukemia

First Posted Date: 2004-03-26

Last Posted Date: 2015-01-14

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 40

Registration Number: NCT00002592

Locations: 🇺🇸
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States

Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia

Phase 3

Completed

Conditions: Leukemia

First Posted Date: 2004-03-19

Last Posted Date: 2010-03-30

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 100

Registration Number: NCT00002789

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

S9920 Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia

Phase 3

Completed

Conditions: Myelodysplastic Syndromes
Leukemia

Interventions: Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: methotrexate
Procedure: allogeneic bone marrow transplantation
Radiation: radiation therapy

First Posted Date: 2004-03-16

Last Posted Date: 2015-03-06

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 240

Registration Number: NCT00005866

Locations: 🇺🇸
University of Mississippi Medical Center, Jackson, Mississippi, United States
🇺🇸
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
🇺🇸
St. Louis University Health Sciences Center, Saint Louis, Missouri, United States

and more 63 locations

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