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

Plasma kinetics for tablet and liquid formulations of 6-mercaptopurine in childhood acute lympholastic leukemia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001236-21-DK

Enrollment

Registered

2013-05-17

Start date

2013-06-11

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood acute lymphoblastic leukemia. MedDRA version: 14.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864

Interventions

Trade Name: Xaluprine Product Name: 6-mercaptopurine Pharmaceutical Form: Oral liquid INN or Proposed INN: Mercaptopurine Other descriptive name: 6-MERCAPTOPURINE MONOHYDRATE Concentration unit: mg/m2

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Countries

Denmark

Contacts

Public ContactClinical Trial information

Kjeld Schmiegelow

Kjeld.Schmiegelow@regionh.dk+4535451357

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026