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

February 3, 2023 updated by: Seoul National University Hospital

Targeted Busulfan, Fludarabine, Etoposide Conditioning Regimen for Hematopoietic Stem Cell Transplantation in Childhood and Adolescent Acute Lymphoblastic Leukemia

To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan, fludarabine, etoposide conditioning regimen in childhood and adolescent ALL.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Daehangno, Jongno-gu
      • Seoul, Daehangno, Jongno-gu, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Busulfan
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year event free survival after hematopoietic stem cell transplantation.
Time Frame: at 1 year
To evaluate 1-year event free survival after hematopoietic stem cell transplantation.
at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engraftment rate
Time Frame: 1, 3, 6 and 12 months after transplantation
To evaluate engraftment rate
1, 3, 6 and 12 months after transplantation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicities associated with hematopoietic stem cell transplantation
Time Frame: 1, 3, 6 and 12 months after transplantation
To evaluate toxicities associated with hematopoietic stem cell transplantation. Toxicities will be assessed with number of participants.
1, 3, 6 and 12 months after transplantation
Acute GVHD
Time Frame: 1, 3, 6 and 12 months after transplantation
To evaluate acute GVHD
1, 3, 6 and 12 months after transplantation
Chronic GVHD
Time Frame: 1, 3, 6 and 12 months after transplantation
To evaluate chronic GVHD
1, 3, 6 and 12 months after transplantation
Treatment related mortality
Time Frame: 1, 3, 6 and 12 months after transplantation
To evaluate treatment related mortality
1, 3, 6 and 12 months after transplantation
Relapse rate
Time Frame: 1, 3, 6 and 12 months after transplantation
To evaluate relapse rate
1, 3, 6 and 12 months after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hyoung Jin Kang, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 5, 2014

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 24, 2014

First Posted (ESTIMATE)

January 28, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUCH_ALL_BuFluVP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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