Acute Lymphoblastic Leukemia MedDRA version: 12.1 Level: LLT Classification code 10000844 Term: Acute lymphoblastic leukaemia
Conditions
Interventions
Product Name: Loulla
Product Code: Loulla
Pharmaceutical Form: Oral liquid
INN or Proposed INN: Mercaptopurine
CAS Number: 50-44-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Only For Children Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for both parts of the study: • Acute Lymphoblastic Leukaemia in complete remission • Patient under maintenance treatment for at least the last 3 months Stable for at least 3 weeks with the same dosage of 6MP (i.e. not more than a 10% variation in dose over the three weeks) • Informed consent form signed by patients or guardians • Documented assent for children above 6 years Inclusion criteria specific to part A: • Aged 12-18 years old • Patients treated with a 6MP dose of at least 40 mg per day • TPMT genotyping for the two following polymorphisms (TPMT* 3B 460 G>A and TPMT* 3C 719 A>G) will be performed if not already available. Patient carrying at least one mutant allele for at least one of these two polymorphisms will be excluded Inclusion criteria specific to part B: • Aged 2-18 years old • TPMT genotyping for the two polymorphisms (TPMT* 3B 460 G>A and TPMT* 3C 719 A>G) will be performed if not already available. Any TPMT deficiency genotype will be authorised to enter part B of the study. But patient carrying out at least one mutant allele for these two polymorphisms needs an adjustment of 6MP dose. The dose of 6MP oral liquid formulation will be adapted according to doctor’s prescription. Are the trial subjects under 18? yes Number of subjects for this age range: 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: Excluion criteria related to pathologies or treatments • Severe bone marrow suppression(White blood cell below 10 years of age and Lansky =50 for patients = 10 years of age • Medical history of hypersensitivity to 6MP or drug excipients • Treatment by allopurinol • Treatment by aminosalicylates • Treatment with Probenecid, Trimethoprim, Penicillins, Phenylbutazone, NSAIDs, Phenytoin • Vaccination with live organism vaccines Exclusion criteria related to the population • Planned travel outside the study area for a substantial portion of the study period • Intake of any experimental treatment during the past three months preceding inclusion or during the study • Patient who, in the judgment of the investigator is not likely to be compliant during the study • Patient linguistically or psychologically unable to understand the information given or formulate his/her assent to be involved • Parents or guardians linguistically or psychologically unable to understand the information given or to give their informed consent or who refuse to give their consent in writing • Patient or parents or guardians who cannot be contacted by phone in case of emergency Extra exclusion criterion for girls of childbearing potential • Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: to characterise the bioavailability of a single 50 mg fixed dose of the O4CP innovative oral liquid formulation versus 50mg registered adult tablets Part B: to assess the pharmacokinetics of an adjusted dose of the O4CP innovative oral liquid formulation given daily for 6 weeks ;Secondary Objective: Part A and part B : To assess the palatability, the pharmacokinetic and the safety of the new 6MP oral liquid formulation;Primary end point(s): Pharmacokinetics: Cmax, Tmax, AUC0-8, AUC0-t ; as well as safety, palatability, satisfaction with treatment use, pharmacogenetic analyses | — |
Countries
Denmark, France, Germany
Outcome results
None listed