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 t...

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...

Associated Conditions: Chronic Myelogenous Leukemia (CML), Essential Thrombocythemia (ET), Polycythemia Vera (PV)

Associated Therapies: Conditioning regimens for allogeneic stem cell transplantation therapy

Clinical Trials

A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant

Phase 2

Active, not recruiting

Conditions: Acute Myeloid Leukemia (AML)
Acute Lymphoid Leukemia (ALL)
Myelodysplastic Syndromes (MDS)

Interventions: Other: Personalized rATG (P-rATG)
Radiation: Hyper fractionated total body irradiation
Drug: Thiotepa
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Melphalan
Drug: GCSF
Drug: Fludarabine

First Posted Date: 2021-05-04

Last Posted Date: 2024-04-18

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 59

Registration Number: NCT04872595

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

Itacitinib for the Prevention of Graft Versus Host Disease

Phase 1

Active, not recruiting

Conditions: Hematologic and Lymphocytic Disorder

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Itacitinib
Drug: Tacrolimus
Drug: Thiotepa

First Posted Date: 2021-04-26

Last Posted Date: 2024-10-24

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 31

Registration Number: NCT04859946

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Target Busulfan Exposure in Children With HSCT in China

Conditions: Hematopoietic Stem Cell Transplantation

First Posted Date: 2021-03-08

Last Posted Date: 2021-03-10

Lead Sponsor: The First Affiliated Hospital of Soochow University

Target Recruit Count: 500

Registration Number: NCT04786002

Locations: 🇨🇳
the First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

Pre-transplant Immunosuppression and Donor Stem Cell Transplant for the Treatment of Severe Hemoglobinopathies

Early Phase 1

Withdrawn

Conditions: Sickle Beta Thalassemia
Beta Thalassemia Major
Sickle Beta 0 Thalassemia
Sickle Beta Plus Thalassemia
Sickle Cell-SS Disease
Sickle Cell Disease

Interventions: Drug: Bortezomib
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Dexamethasone
Drug: Fludarabine Phosphate
Procedure: Hematopoietic Cell Transplantation
Biological: Lapine T-Lymphocyte Immune Globulin
Drug: Mycophenolate Mofetil
Procedure: Plasmapheresis
Biological: Rituximab
Drug: Tacrolimus

First Posted Date: 2021-03-02

Last Posted Date: 2024-10-24

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT04776850

Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS

Phase 2

Recruiting

Conditions: Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Acute Myeloid Leukemia

Interventions: Drug: Busulfan
Drug: Cladribine
Drug: Fludarabine Phosphate
Procedure: Hematopoietic Cell Transplantation
Drug: Thiotepa
Drug: Venetoclax

First Posted Date: 2021-01-13

Last Posted Date: 2024-11-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 324

Registration Number: NCT04708054

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma

Phase 1

Active, not recruiting

Conditions: Large B-cell Lymphoma

Interventions: Biological: CNCT19
Drug: Gemcitabine Injection
Drug: busulfan
Drug: Melphalan Injection

First Posted Date: 2020-12-30

Last Posted Date: 2024-03-15

Lead Sponsor: Zou Dehui

Target Recruit Count: 20

Registration Number: NCT04690192

Locations: 🇨🇳
Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, China

A Single-arm Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.

Phase 2

Recruiting

Conditions: Leukemia
Graft-versus-host-disease

Interventions: Drug: Cytarabine
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Me-CCNU
Drug: Rabbit antithymocyte globulin
Drug: Tocilizumab
Procedure: Allogeneic HSCT
Drug: Cyclosporin A
Drug: Mycophenolate Mofetil
Drug: MTX

First Posted Date: 2020-12-29

Last Posted Date: 2023-02-21

Lead Sponsor: Yi Luo

Target Recruit Count: 46

Registration Number: NCT04688021

Locations: 🇨🇳
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China

Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders

Phase 2

Recruiting

Conditions: AML
ALL
NHL or HL
Inherited Metabolic Disorders
Bone Marrow Failure
HLH
MDS
MPD Withou Myelofibrosis
Hemoglobinopathies

Interventions: Drug: Clofarabine
Drug: Fludarabine
Drug: Busulfan
Drug: Cyclosporine-A
Drug: Mycophenolate Mofetil
Biological: Cord Blood Graft

First Posted Date: 2020-11-25

Last Posted Date: 2024-12-02

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 31

Registration Number: NCT04644016

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

A Study Comparing Haploidentical Hematopoietic Stem Cell Transplantations (HSCTs) From Young Non-first-degree and Older First-degree Donors in Hematological Malignancies

Phase 3

Recruiting

Conditions: Leukemia

Interventions: Drug: Cytarabine
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Me-CCNU
Drug: Rabbit antithymocyte globulin
Procedure: Allogeneic HSCT
Drug: Cyclosporin A
Drug: Mycophenolate Mofetil
Drug: MTX

First Posted Date: 2020-09-14

Last Posted Date: 2023-02-21

Lead Sponsor: First Affiliated Hospital of Zhejiang University

Target Recruit Count: 160

Registration Number: NCT04547049

Locations: 🇨🇳
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China
🇨🇳
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
🇨🇳
The Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China

and more 5 locations

Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis

Phase 2

Recruiting

Conditions: Secondary Myelofibrosis
Primary Myelofibrosis

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Melphalan
Drug: Methotrexate
Drug: Mycophenolate Mofetil
Drug: Ruxolitinib
Drug: Tacrolimus
Radiation: Total-Body Irradiation
Procedure: Computed Tomography
Procedure: Echocardiography
Procedure: Bone Marrow Aspiration and Biopsy
Procedure: Magnetic Resonance Imaging
Procedure: Ultrasound Imaging

First Posted Date: 2020-05-12

Last Posted Date: 2024-10-17

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 45

Registration Number: NCT04384692

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

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