busulfan / Generic mfg.  >>  Phase 4
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15 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
busulfan / Generic mfg.
NCT00361140: Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)

Completed
4
72
US
Busulfan, Busulfex(R), Fludarabine, Fludarabine Phosphate
H. Lee Moffitt Cancer Center and Research Institute
Myelodysplastic Syndromes, Myeloproliferative Disorders, Leukemia, Lymphocytic, Myeloma, Lymphoma
02/12
02/12
NCT01071486: Busulfan Pharmacokinetic Analysis and GST Polymorphism in Adults Undergoing Hematological Stem Cell Transplantation

Withdrawn
4
0
RoW
Hematological Stem Cell Transplantation
Rambam Health Care Campus, Israel Cancer Association
Busulfan Pharmacokinetic Analysis, GST Genetic Polymorphism
10/12
10/12
NCT01339988: Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT)

Unknown status
4
10
NA
Busulfan/Cyclophosphamide, Cytoxan
Tel-Aviv Sourasky Medical Center
Acute Leukemias, Chronic Leukemias, Myelodysplastic Syndrome, Juvenile Myelomonocytic Leukemia
06/14
06/19
2004-003854-25: Individuální úprava dávkového režimu vysokodávkového busulfanu (HD-BUSU) u nemocných před transplantací krvetvorných buněk jako prevence toxicity.

Ongoing
4
60
Europe
Myleran 2 mg tbl obd 100x2mg GOK GB R, 21157, 21157 Myleran 2 mg tbl obd 100x2mg GOK GB R, 21157 Myleran 2 mg tbl obd 100x2mg GOK GB R
Interní grantová agentura, Ministerstvo zdravotnictví ČR
Myleran se bude užívat jako imunosupresivum u nemocných před transplantací kostní dřeně.
 
 
2005-002345-39: B-NHL BFM 04

Ongoing
4
20
Europe
Dexacortal, Methotrexate, Sendoxan, Adriamycin, Oncovin STADAPharm, Cytarabine Pharmacia, Vepesid, Holoxan, Precortalon Aquosum, Eldisine, Myleran, Thiotepa, Neupogen, Methotrexate Pharmacia, 14320, Dexametasone, Metotrexat, Cyclophosfamide, Adriamycin, Vincristine, Cytarabine, Etoposide, Ifosfamide, Prednisolone, Vindesin, Busulfan, Thiotepa, Filgrastin, Methotrexate, Dexametasone, Metotrexat, Cyclophosfamide, Adriamycin, Vincristine, Cytarabine, Etoposide, Ifosfamide, Prednisolone, Vindesin, Busulfan, Thiotepa, Filgrastin, Methotrexate
NOPHO NHL-group
B-cell lymphoma or B-ALL in children up to 18 years of age
 
 
ChiCTR-IPR-15005779: Efficacy of different dosage of antithymocyte globulin in HLA-matched allogeneic hematopoietic stem cell transplantation for thalassemia major treatment: a multi-center, open, randomized, controlled clinical study

Not yet recruiting
4
100
 
Busulfan+fludarabine+cyclophosphamiade+antithymocyte globulin(10mg/kg) ;Busulfan+fludarabine+cyclophosphamiade+antithymocyte globulin(8mg/kg)
First Affilited Hospital of Guangxi Medical University; Level of the institution：, self-financing
thalassemia major
 
 
NCT02784561: Study of Busulfan and FLAG Conditioning Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation

Unknown status
4
80
NA
Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd), Myleran, Busulfex, Cytarabine(Actavis Italy S.p.A), Ara-C, Fludarabine (Bayer), fludarabine phosphate (Fludara), granulocyte colony-stimulating factor (KirinKunpeng), G-CSF（granulocyte colony-stimulating factor ）, rabbit ATG（Sanofi/Genzyme）, Thymoglobuline
Chinese PLA General Hospital, 309th Hospital of Chinese People's Liberation Army, Beijing Naval General Hospital, Space Center Hospital, Peking University
Leukemia
07/19
07/20
NCT02670564: ALL SCTped FORUM - Pharmacogenomic Study (add-on Study)

Recruiting
4
1000
Europe
Pharmacogenomics, DNA analyses, Busulfan plasma level measurements
Swiss Pediatric Oncology Group, ALL SCTped Forum
Acute Lymphoblastic Leukemia
04/21
04/26
NCT03171831: Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major

Unknown status
4
30
RoW
Busulfan, Bu, Cyclophosphamide, Cy, Fludarabine, Flu, Mycophenolate mofetil, MMF, Tacrolimus, FK506, Methotrexate, MTX, Thymoglobulin, ATG, Basiliximab, Simulect
First Affiliated Hospital of Guangxi Medical University
Thalassemia Major
12/21
04/22
NCT04009525: Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major: A Multicenter, Prospective Clinical Study

Completed
4
823
RoW
Busulfan, Bu, Cyclophosphamide, Cy, Fludarabine, Flu, Thymoglobulin, ATG, cyclosporine A, CsA, Mycophenolate mofetil, MMF, Tacrolimus, FK506, Methotrexate, MTX
First Affiliated Hospital of Guangxi Medical University, Peking University People's Hospital, Ruijin Hospital, The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army, LiuZhou People's Hospital, The First People's Hospital of Yunnan, Liuzhou Workers Hospital, Xinqiao Hospital of Chongqing, Affiliated Hospital of Youjiang University of Ethnic Medicine, Hainan People's Hospital, Maoming People's Hospital, Red Cross Hospital of Yulin City, Guilin Medical College, Wuzhou People's Hospital, Guangxi Autonomous Region People's Hospital, The 920th Hospital of Joint Logistics Support Force of People's Liberation Army
Thalassemia Major
07/23
10/23
ChiCTR2000035002: The pharmacokinetics reasearch of busulfan used in hematopoietic stem cell transplantation in pediartric patints, a prospective and open clinical reasearch

Recruiting
4
60
 
busulfan
Pediatric Hospital affiliated to Fudan University; Pediatric Hospital affiliated to Fudan University, Government, Hospital
Rare diseases in children
 
 
NCT06069180: The Optimization of Conditioning Regimen for HLA Matched HSCT in SAA

Recruiting
4
160
RoW
Busulfan, Flu/Cy/ATG or Cy/ATG
Peking University People's Hospital
Severe Aplastic Anemia
12/24
12/25
ChiCTR2300073330: A prospective, single-arm, open, multicenter clinical trial of complement protein C5 monoclonal antibody bridging allogeneic hematopoietic stem cell transplantation for PNH

Not yet recruiting
4
20
 
Pretreatment scheme for full-sib compatibility: C5 McAb 600 mg for -9 days.Fludarabine (FLU) 30 mg/m2/d x 6 d (-7 to -2D) + CY 50 mg/kg/d x 2D (-4 to -3D) + ATG 2.5mg/kg/d x 5 d (-8 to -4D). ;Alternative donor (unrelated donor, haplotype donor) conditioning regimen: C5 McAb 600 mg for -9 days. Busulfan (BU) 3.2 mg/kg/d (0.8 mg/kg, q6h) x 2D (-7 to -6d) + cyclophosphamide (CY) 50 mg/kg/d x 4D (-5 to -2D) + ATG 2.5 mg/kgd x 4D (-5 to -2D). ;Treatment regimen for GVHD: Grade II treatment, methylprednisolone 1-2 mg/kg, divided into two doses, second-line drugs can be selected as appropriate: FK506, MMF, MTX, ATG, CD25 monoclonal antibody, etc. Hormone reduction as appropriate ;Symptomatic and supportive treatment: Transplant-related complications such as infection, bleeding, hemorrhagic cystitis, epilepsy and mucositis, as well as immunoglobulin and nutritional support were routinely given to the participating units. ;Other concomitant therapy: For hemoglobin < 60 g/L or red blood cell transfusion therapy is allowed in emergency. Hormones are allowed to control acute hemolysis, hematopoietic and erythropoietic drugs are allowed, and G-CSF can be used when neutrophils are less than 1 x 10^9/L. In the case of organ dysfunction, the use of drugs to protect organs is allowed. Anti-infective drugs are permitted in the presence of infection.
Hongci Hematology Branch of the First Affiliated Hospital of Soochow University; Hongci Hematology Branch of the First Affiliated Hospital of Soochow University, Self-funded
Classic PNH and PNH with bone marrow failure
 
 
ChiCTR2300074009: Prospective, single-arm, open, multicenter clinical trial of monoclonal antibody to complement protein C5 for the prevention of GVHD after haplotype hematopoietic stem cell transplantation for SAA

Not yet recruiting
4
20
 
Haplotype transplantation pretreatment protocol:Busulfan (BU) 3.2 mg/kg/d (0.8 mg/kg, q6h) × 2D (-7 to - 6d) + cyclophosphamide (CY) 50 mg/kg/d × 4D (-5 to -2D) + ATG 2.5 mg/kgd × 4D (- 5 to -2D).Application of C5 monoclonal antibody: 1 dose (600 mg) on day + 7 after transplantation.Treatment regimen for GVHD: Grade II treatment, methylprednisolone 1 ~ 2mg/kg, divided into two doses, second-line drugs can be selected as appropriate: FK506, MMF, MTX, ATG, CD25 monoclonal antibody, etc.Hormone reduction as appropriate.Symptomatic and supportive treatment: Transplant-related complications such as infection, bleeding, hemorrhagic cystitis, epilepsy and mucositis, as well as immunoglobulin and nutritional support were routinely given to the participating units.Transfusion of red blood cells is allowed for hemoglobin < 60g/L or emergency treatment.Hormones are allowed to control acute hemolysis, hematopoietic and erythropoietic drugs are allowed, and G-CSF can be used when neutrophils are less than 1 × 10^9/L.When organ function damage occurs, it is allowed to use drugs to protect organs.Anti-infective drugs are permitted in the presence of infection.
Hongci Hematology Branch of the First Affiliated Hospital of Soochow University; Hongci Hematology Branch of the First Affiliated Hospital of Soochow University, Self-financing
Haplotype hematopoietic stem cell transplantation for SAA
 
 
ChiCTR2300073329: Prospective, open, multicenter clinical trial of complement protein C5 monoclonal antibody and allogeneic hematopoietic stem cell transplantation for PNH

Not yet recruiting
4
90
 
C5 McAb 600 mg was administered once a week for 4 weeks, and C5 McAb 900 mg was administered once every two weeks from the fifth week, and then long-term administration. ;Pretreatment scheme for full-sib compatibility: Fludarabine (FLU) 30 mg/m2/d x 6 d (- 7 to -2D) + CY 50 mg/kg/d x 2D (-4 to -3D) + ATG 2.5 mg/kg/d x 5d (-8 to -4D). ;Alternative donor (unrelated donor, haplotype donor) conditioning regimen: Busulfan (BU) 3.2 mg/kg/d (0.8 mg/kg, q6h) x 2D (-7 to -6d) + cyclophosphamide (CY) 50 mg/kg/d x 4D (-5 to -2D) + ATG 2.5 mg/kg per day x 4D (-5 to -2D). ;Treatment regimen for GVHD: Grade II treatment, methylprednisolone 1-2 mg/kg, divided into two doses, second-line drugs can be selected as appropriate: FK506, MMF, MTX, ATG, CD25 monoclonal antibody, etc.Hormone reduction as appropriate. ;Symptomatic and supportive treatment: Transplant-related complications such as infection, bleeding, hemorrhagic cystitis, epilepsy and mucositis, as well as immunoglobulin and nutritional support were routinely given to the participating units.
Hongci Hematology Branch of the First Affiliated Hospital of Soochow University; Hongci Hematology Branch of the First Affiliated Hospital of Soochow University, Self-funded
Classic PNH and PNH with bone marrow failure
 
 

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