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Targeted Busulfan, Fludarabine, Etoposide Conditioning Regimen for HSCT in Childhood and Adolescent ALL.

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Busulfan
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring hematopoietic stem cell transplantation

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who are diagnosed as ALL.
  2. Patients who need hematopoietic stem cell transplantation
  3. Age: up to 21 years
  4. Performance status: ECOG 0-2.
  5. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction > 30% and ejection fraction > 45%. 2. Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal. 3. Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2.
  6. Patients must lack any active viral infections or active fungal infection.
  7. Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
  8. Patients (or one of parents if patients age < 19) should sign informed consent.

Exclusion Criteria:

  1. Pregnant or nursing women.
  2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
  3. Psychiatric disorder that would preclude compliance.

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Busulfan

Arm Description

Drug: Busulfan First dose: busulfan (120 mg/m2 ivs once daily) (if age<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study

Outcomes

Primary Outcome Measures

1-year event free survival after hematopoietic stem cell transplantation.
To evaluate 1-year event free survival after hematopoietic stem cell transplantation.

Secondary Outcome Measures

Engraftment rate
To evaluate engraftment rate

Full Information

First Posted
January 9, 2014
Last Updated
February 3, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02047578
Brief Title
Targeted Busulfan, Fludarabine, Etoposide Conditioning Regimen for HSCT in Childhood and Adolescent ALL.
Official Title
Targeted Busulfan, Fludarabine, Etoposide Conditioning Regimen for Hematopoietic Stem Cell Transplantation in Childhood and Adolescent Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2014 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan, fludarabine, etoposide conditioning regimen in childhood and adolescent ALL.
Detailed Description
Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study the investigators plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
hematopoietic stem cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Busulfan
Arm Type
Experimental
Arm Description
Drug: Busulfan First dose: busulfan (120 mg/m2 ivs once daily) (if age<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
Intervention Type
Drug
Intervention Name(s)
Busulfan
Intervention Description
First dose: busulfan (120 mg/m2 ivs once daily) (if age<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
Primary Outcome Measure Information:
Title
1-year event free survival after hematopoietic stem cell transplantation.
Description
To evaluate 1-year event free survival after hematopoietic stem cell transplantation.
Time Frame
at 1 year
Secondary Outcome Measure Information:
Title
Engraftment rate
Description
To evaluate engraftment rate
Time Frame
1, 3, 6 and 12 months after transplantation
Other Pre-specified Outcome Measures:
Title
Toxicities associated with hematopoietic stem cell transplantation
Description
To evaluate toxicities associated with hematopoietic stem cell transplantation. Toxicities will be assessed with number of participants.
Time Frame
1, 3, 6 and 12 months after transplantation
Title
Acute GVHD
Description
To evaluate acute GVHD
Time Frame
1, 3, 6 and 12 months after transplantation
Title
Chronic GVHD
Description
To evaluate chronic GVHD
Time Frame
1, 3, 6 and 12 months after transplantation
Title
Treatment related mortality
Description
To evaluate treatment related mortality
Time Frame
1, 3, 6 and 12 months after transplantation
Title
Relapse rate
Description
To evaluate relapse rate
Time Frame
1, 3, 6 and 12 months after transplantation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are diagnosed as ALL. Patients who need hematopoietic stem cell transplantation Age: up to 21 years Performance status: ECOG 0-2. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction > 30% and ejection fraction > 45%. 2. Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal. 3. Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2. Patients must lack any active viral infections or active fungal infection. Appropriate donor is available: Matched in 6/6 of A, B, DR loci. Patients (or one of parents if patients age < 19) should sign informed consent. Exclusion Criteria: Pregnant or nursing women. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. Psychiatric disorder that would preclude compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyoung Jin Kang, MD, PhD
Phone
82 2 2072 3304
Email
kanghj@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Che Ry Hong, MD
Phone
82 2 2072 3778
Email
cheryhong84@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung Jin Kang, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Daehangno, Jongno-gu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyoung Jin Kang, MD, PhD
Phone
82 2 2072 3304
Email
kanghj@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Ji Won Lee, MD
Phone
82 2 2072 4192
Email
agnesjw@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Targeted Busulfan, Fludarabine, Etoposide Conditioning Regimen for HSCT in Childhood and Adolescent ALL.

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