Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

NCT01472055 | Unknown Phase 2 DMC

• 1 other identifier: SNUCH-SCT-1101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.

Conditions

Acute Leukemia; Chronic Leukemia; Severe Aplastic Anemia

Keywords

Hematopoietic stem cell transplantation with fludarabine based conditioning

Outcome Measures

Primary Outcomes (1)

• Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients

  0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose

Secondary Outcomes (3)

• Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients

  3 years

• Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine

  1, 3, 6 and 12 months after transplantation

• Evaluation of therapy related toxicity, significant adverse reaction

  for 4 weeks

Study Arms (1)

Fludarabine

EXPERIMENTAL

Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients

Drug: Fludarabine

Interventions

Fludarabine DRUG

1. Fludarabine 40 mg/m\^2 once a day intravenous administration over 30 min 2. Development of sampling-minimized analysis method through individualized pharmacokinetics Sampling time: 0hr (pre-dose), 30 min (post-dose), 1hr, 3hr, 5hr, 8hr, 24hr 3. Population pharmacokinetics analysis 4. Comparative analysis of population pharmacokinetics in pediatric and adult patients 5. Analysis of population pharmacokinetics, toxicity, engraftment rate, survival rate

Fludarabine

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Conditioning regimen including fludarabine
• Age: \< 19 years old
• Functional class: ECOG 0-2
• No loss of function of major organs. Criteria may be individualized.
• Heart: shortening fraction \> 30%, ejection fraction \> 45%.
• Liver: total bilirubin \< 2 ⅹ upper limit of normal; ALT \< 3 ⅹ upper limit of normal.
• Kidney: creatinine \< 2 ⅹ normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
• No active viral or fungal infection
• Appropriate hematopoietic stem cell donor
• Informed consent from patients' parents

You may not qualify if:

• Pregnant or breast feeding
• Disease progression due to clinical test
• Psychiatric disease may interfere with clinical test
• Whether attending physician consider the patient inappropriate for study enrollment

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Food and Drug Safety, Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Daehangno, Jongno-gu, South Korea

RECRUITING

MeSH Terms

Conditions

Anemia, Aplastic

Interventions

fludarabine

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases

Study Officials

• Hyoung Jin Kang, MD., PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyoung Jin Kang, MD, PhD

CONTACT

+82 2 2072 0177; kanghj@snu.ac.kr

Ji Won Lee, MD

CONTACT

+82 2 2072 3452; agnesjw@hanmail.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 6, 2011
• First Posted: November 16, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

KR (1)