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Pharmacokinetic Study of Intravenous Busulfan as Conditioning Regimen for Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia


Phase 2
18 Years
55 Years
Open (Enrolling)
Both
Acute Leukemia

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Trial Information

Pharmacokinetic Study of Intravenous Busulfan as Conditioning Regimen for Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Area Under Curve (AUC)

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Jiong HU, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Authority:

China: Ethics Committee

Study ID:

RJH-Busulfan

NCT ID:

NCT01498016

Start Date:

November 2011

Completion Date:

June 2014

Related Keywords:

  • Acute Leukemia
  • acute leukemia
  • allogeneic stem cell transplantation
  • busulfan
  • Leukemia
  • Acute Disease

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