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Pharmacokinetic Study of Busulfan in Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT01498016
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
127
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed 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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetic Study of Intravenous Busulfan as Conditioning Regimen for Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia
Study Start Date :
Nov 1, 2011
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Iv-Busulfan

iv busulfan 1.6mg/kg given q12h

Drug: Busulfan
Iv busulfan 1.6mg/kg q12h D1- D4
Other Names:
  • study group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area Under Curve (AUC) [predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose]

      busulifan blood concentration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patient with acute myeloid or lymphoblastic leukemia in 1st or second remission

    • age 18-55 years

    • with inform consent

    • no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage

    • HLA matched related (6/6) or unrelated donors (at least 8/10)

    Exclusion Criteria:

    • age less than 18 years or over 56 years

    • HLA mismatched related donor

    • liver function/renal function damage (over 2 X upper normal range)

    • with mental disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Blood & Marrow Transplantation Center, RuiJin Hospital Shanghai China 200025

    Sponsors and Collaborators

    • Shanghai Jiao Tong University School of Medicine

    Investigators

    • Principal Investigator: Jiong HU, M.D., Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiong HU, Head, Blood &^ Marrow Transplantation Center, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT01498016
    Other Study ID Numbers:
    • RJH-Busulfan
    First Posted:
    Dec 23, 2011
    Last Update Posted:
    May 21, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Jiong HU, Head, Blood &^ Marrow Transplantation Center, Shanghai Jiao Tong University School of Medicine
    acute leukemia
    allogeneic stem cell transplantation
    busulfan
    Additional relevant MeSH terms:
    Leukemia
    Acute Disease
    Busulfan

    Study Results

    No Results Posted as of May 21, 2021