Online Trial Tracker - Larvol Sigma

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

busulfan / Generic mfg.

NCT00361140: Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)

Completed

Busulfan, Busulfex(R), Fludarabine, Fludarabine Phosphate

H. Lee Moffitt Cancer Center and Research Institute

Myelodysplastic Syndromes, Myeloproliferative Disorders, Leukemia, Lymphocytic, Myeloma, Lymphoma

02/12

NCT01071486: Busulfan Pharmacokinetic Analysis and GST Polymorphism in Adults Undergoing Hematological Stem Cell Transplantation

Withdrawn

RoW

Hematological Stem Cell Transplantation

Rambam Health Care Campus, Israel Cancer Association

Busulfan Pharmacokinetic Analysis, GST Genetic Polymorphism

10/12

NCT01339988: Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT)

Unknown status

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

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

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

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

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

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

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

Recruiting

800

RoW

Busulfan, Bu, Cyclophosphamide, Cy, Fludarabine, Flu, Thymoglobulin, ATG, cyclosporine A, CsA, Mycophenolate mofetil, MMF, Tacrolimus, FK506, Methotrexate, MTX, Basiliximab, Simulect, Ruxolitinib

First Affiliated Hospital of Guangxi Medical University, Peking University People's Hospital, Ruijin Hospital, The 923th Hospital of People's Liberation Army, Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou General Hospital, Hainan General Hospital, The Affiliated Hospital Of Guizhou Medical University, The First People's Hospital of Yunnan

Thalassemia Major

05/22

05/23

ChiCTR2000035002: The pharmacokinetics reasearch of busulfan used in hematopoietic stem cell transplantation in pediartric patints, a prospective and open clinical reasearch

Recruiting

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

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

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

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 × 109/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

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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