Clinical Trials Logo

Clinical Trial Summary

Intravenous Busulfan (iv-Bu) is commonly used as part of preparation regimen for allogeneic hematopoietic stem cell transplantation for patients with acute leukemia. Though the pharmacokinetics data are available for population from America, Europe and Japan or Korea in Asia, there are no data in Chinese population. It is shown that high Bu concentration are associated with the toxicity such as veno-occlusion disease and lower concentration is correlated with reduced anti-leukemia effect, thus the monitoring of Bu and/or the strategy to achieve an optimal target Bu concentration are accepted to avoid toxicity while maintain the anti-leukemia effect which may overall improve the outcome of allo-SCT. Thus we conduct the pharmacokinetic study in Chinese population.


Clinical Trial Description

All patients received intravenous Busulfan based conditioning regimen for allogeneic stem cell transplantation. Intravenous Busulfan (iv-Bu) was given 1.6mg/kg twice daily for 4 days as in the conditioning regimen. Blood samples were obtained after first and 7th dose of iv Bulsulfan. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01498016
Study type Interventional
Source Shanghai Jiao Tong University School of Medicine
Contact Jiong HU, M.D.
Phone 86-21-64370045-601818
Email hujiong@medmail.com.cn
Status Recruiting
Phase Phase 2
Start date November 2011
Completion date June 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05088356 - Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft Phase 1
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Recruiting NCT04969601 - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings Phase 1/Phase 2
Recruiting NCT02356159 - Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation Phase 1/Phase 2
Withdrawn NCT05170828 - Cryopreserved MMUD BM With PTCy for Hematologic Malignancies Phase 1
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Active, not recruiting NCT01956630 - Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT Phase 1/Phase 2
Completed NCT00988013 - Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies N/A
Enrolling by invitation NCT01728402 - Pathogenesis of Hematologic Malignancies
Active, not recruiting NCT03595800 - Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen Phase 3
Completed NCT02440178 - Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia Phase 2
Recruiting NCT05071482 - Flumatinib Versus Imatinib Combined With Chemotherapy for de Novo Ph+ ALL Phase 4
Completed NCT03042676 - Electronic Database for the Follow up of the ATG_FamilyStudy
Withdrawn NCT03138395 - iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML N/A
Completed NCT04597086 - Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients N/A
Terminated NCT03588936 - Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant Phase 1
Recruiting NCT05521204 - Olverembatinib for FGFR1-rearranged Neoplasms Phase 2
Not yet recruiting NCT04084327 - Immunophenotyping of Acute b Cell Lymphoblstic Leukemia
Terminated NCT00852709 - Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias Phase 1
Not yet recruiting NCT06026839 - Longitudinal Study on the QoL of Pediatric Patients After HSCT and Its Influencing Factors