Comparison of tablet and liquid formulations of 6-mercaptopurine in children with blood cancer

Phase 1

• Conditions: Childhood acute lymphoblastic leukemia.; MedDRA version: 14.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-001236-21-DK
• Lead Sponsor: Kjeld Schmiegelow

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-17
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Childhood acute lymphoblastic leukemia patients, age 0-18 years at diagnosis. Treated at department of pediatrics and adolescent medicin, Rigshospitalet, Copenhagen.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

None

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this trial in to investigate whether previous findings, from a trial conducted on healthy adults regarding plasma kinetics and bioavailability of tablet (Puri-Nethol) and oral liquid formulation (Xaluprine) of 6-mercaptopurine, is similar in the target population, children with ALL.;Secondary Objective: As a secondary objectiv, we want to investigate the intra-individual (within each patient) variability upon successive doses of 6-mercaptopurine, since it has been suggested in a trial on healty adult volunteers, that the oral liquid formulation exhibits less intra-individual variation, compared to the tablet formulation.;Primary end point(s): The primary end-point is Tmax (time to maximum concentration).;Timepoint(s) of evaluation of this end point: The Tmax will be evaluated continuously, as the laboratory analysis are being conducted.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary end points is Cmax, AUC, t½;Timepoint(s) of evaluation of this end point: The secundary endpoints will be evaluated continuously, as the laboratory analysis are being conducted.