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Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML

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ClinicalTrials.gov Identifier: NCT01274195
Recruitment Status : Unknown
Verified November 2013 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : January 11, 2011
Last Update Posted : November 19, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:
In this study we plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplantation Drug: Busulfan Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML
Study Start Date : January 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. To evaluate 1-year event free survival after hematopoietic stem cell transplantation. [ Time Frame: For 4 days used Buslufan through pharmacokinetic study in hematopoietic stem cell transplantation ]
    To evaluate 1-year event free survival after hematopoietic stem cell transplantation.


Secondary Outcome Measures :
  1. To evaluate engraftment rate, toxicities associated with hematopoietic stem cell transplantation, acute and chronic GVHD, treatment related mortality and relapse rate. [ Time Frame: 1, 3, 6 and 12 months after transplantation ]
    To evaluate engraftment rate, toxicities associated with hematopoietic stem cell transplantation, acute and chronic GVHD, treatment related mortality and relapse rate.


Eligibility Criteria

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who are diagnosed as AML.
  2. Patients who need hematopoietic stem cell transplantation with busulfan based conditioning regimen.
  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 < 20) 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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274195


Contacts
Contact: Hyoung Jin Kang, MD, PhD 82 2 2072 0177 kanghj@snu.ac.kr
Contact: Ji Won Lee, MD 82 2 2072 0177 agnesjw@hanmail.net

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Daehangno, Jongno-gu, Korea, Republic of
Contact: Hyoung Jin Kang, MD, PhD    82 2 2072 0177    kanghj@snu.ac.kr   
Contact: Ji Won Lee, MD    82 2 2072 0177    agnesjw@hanmail.net   
Principal Investigator: Hyo Seop Ahn, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hyoung Jin Kang, M.D., Ph.D Seoul National University Hospital
More Information

ClinicalTrials.gov Identifier: NCT01274195     History of Changes
Other Study ID Numbers: SNUCH-SCT -1001
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Seoul National University Hospital:
Hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Fludarabine
Fludarabine phosphate
Busulfan
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists