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

Primary Purpose

Acute Leukemia

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Busulfan

About this trial

This is an interventional treatment trial for Acute Leukemia focused on measuring acute leukemia, allogeneic stem cell transplantation, busulfan

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Blood & Marrow Transplantation Center, RuiJin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iv-Busulfan

Arm Description

iv busulfan 1.6mg/kg given q12h

Outcomes

Primary Outcome Measures

Area Under Curve (AUC)

busulifan blood concentration

Secondary Outcome Measures

Full Information

NCT ID

NCT01498016

First Posted

December 19, 2011

Last Updated

May 19, 2021

Sponsor

Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01498016

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 2011 (undefined)

Primary Completion Date

January 2022 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Leukemia

Keywords

acute leukemia, allogeneic stem cell transplantation, busulfan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iv-Busulfan

Arm Type

Experimental

Arm Description

iv busulfan 1.6mg/kg given q12h

Intervention Type

Drug

Intervention Name(s)

Busulfan

Other Intervention Name(s)

study group

Intervention Description

Iv busulfan 1.6mg/kg q12h D1- D4

Primary Outcome Measure Information:

Title

Area Under Curve (AUC)

Description

busulifan blood concentration

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiong HU, M.D.

Phone

86-21-64370045-601818

hujiong@medmail.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiong HU, M.D.

Organizational Affiliation

Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Blood & Marrow Transplantation Center, RuiJin Hospital

City

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiong HU, M.D.

Phone

86-21-64370045

Ext

601818

hujiong@medmail.com.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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