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

NCT01498016 | Unknown Phase 2

• 1 other identifier: RJH-Busulfan
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Leukemia

Keywords

acute leukemia; allogeneic stem cell transplantation; busulfan

Outcome Measures

Primary Outcomes (1)

• Area Under Curve (AUC)

  busulifan blood concentration

  predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose

Study Arms (1)

Iv-Busulfan

EXPERIMENTAL

iv busulfan 1.6mg/kg given q12h

Drug: Busulfan

Interventions

Busulfan DRUG

Iv busulfan 1.6mg/kg q12h D1- D4

Also known as: study group

Iv-Busulfan

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, 200025, China

RECRUITING

MeSH Terms

Interventions

Busulfan

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Jiong HU, M.D.

  Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong HU, M.D.

CONTACT

86-21-64370045-601818; hujiong@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Blood &^ Marrow Transplantation Center

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 23, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)