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

This study is currently recruiting participants.
Verified May 2016 by Jiong HU, Shanghai Jiao Tong University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498016
First Posted: December 23, 2011
Last Update Posted: May 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine
  Purpose
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 Intervention Phase
Acute Leukemia Drug: Busulfan Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jiong HU, Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Area Under Curve (AUC) [ Time Frame: predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose ]

Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iv-Busulfan
iv busulfan 1.6mg/kg given q12h
Drug: Busulfan
Iv busulfan 1.6mg/kg q12h D1- D4
Other Name: study group

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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498016


Contacts
Contact: Jiong HU, M.D. 86-21-64370045-601818 hujiong@medmail.com.cn

Locations
China
Blood & Marrow Transplantation Center, RuiJin Hospital Recruiting
Shanghai, China, 200025
Contact: Jiong HU, M.D.    86-21-64370045 ext 601818    hujiong@medmail.com.cn   
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
  More Information

Responsible Party: Jiong HU, Head, Blood &^ Marrow Transplantation Center, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01498016     History of Changes
Other Study ID Numbers: RJH-Busulfan
First Submitted: December 19, 2011
First Posted: December 23, 2011
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jiong HU, Shanghai Jiao Tong University School of Medicine:
acute leukemia
allogeneic stem cell transplantation
busulfan

Additional relevant MeSH terms:
Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Busulfan
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Myeloablative Agonists