NOPHO ALL-2008 PILOT STUDY ON CONSOLIDATION THERAPY FOR CHILDREN AND YOUNG ADULTS WITH ACUTE LYMPHOBLASTIC LEUKAEMIA - ALL2008p

Status

Active, not recruiting

Phases

Phase 1Phase 2Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004021-19-DK

Enrollment

Registered

2007-08-13

Start date

2008-03-25

Completion date

Unknown

Last updated

2017-04-03

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

Conditions

Acute lymphoblastic leukemia in children 1.0-18 years of age MedDRA version: 9.1 Level: LLT Classification code 10066109 Term: Precursor B-lymphoblastic leukemia acute

Interventions

Product Name: 6-mercaptopurine Pharmaceutical Form: Tablet Other descriptive name: MERCAPTOPURINE Concentration unit: g gram(s) Concentration type: equal Concentration number: 0.050- Product Name: Me

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. B-cell precursor ALL with a WBC at diagnosis =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: No additional (see E3)

Design outcomes

Primary

Measure	Time frame
Main Objective: To increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG L-Asparaginase-therapy and interspersed high-dose methotrexate infusions. Thus, the trial will also test the feasability of this particular drug combination.;Secondary Objective: The relationship of the post-HighDose-Methotrexate (MTX) Minimal redisual diseaea levels with the dose of 6Mercaptopurine (6MP), thiopurine methyltransferase activity, red blood cell 6MP and MTX metabolite levels and presence of asparaginase antibodies. Development of asparaginase-antibodies;Primary end point(s): The primary goal of the present study is to increase the 6MP dose to 50 mg/m2 during in one or two consolidation HD-MTX courses in at least 30% of the patients and to 75 mg/m2 during one course of HD-MTX in at least 10% of the patients	—

Measure

Time frame

Main Objective: To increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG L-Asparaginase-therapy and interspersed high-dose methotrexate infusions. Thus, the trial will also test the feasability of this particular drug combination.;Secondary Objective: The relationship of the post-HighDose-Methotrexate (MTX) Minimal redisual diseaea levels with the dose of 6Mercaptopurine (6MP), thiopurine methyltransferase activity, red blood cell 6MP and MTX metabolite levels and presence of asparaginase antibodies. Development of asparaginase-antibodies;Primary end point(s): The primary goal of the present study is to increase the 6MP dose to 50 mg/m2 during in one or two consolidation HD-MTX courses in at least 30% of the patients and to 75 mg/m2 during one course of HD-MTX in at least 10% of the patients

—

Countries

Denmark, Finland, Sweden

Outcome results

None listed

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