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

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

Registration Number: EUCTR2007-004021-19-SE

Lead Sponsor: Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

1.B-cell precursor ALL with a WBC at diagnosis <100 x109/L.
2.Age 1.0-17.9 years.
3.No t(9;22)-translocation. No hypodiploidy. No 11q23[MLL]-aberrations. No translocation t(1;19).
4.No TPMT-deficiency.
5.Clinical remission obtained day 29.
6.No known intolerance to MTX.
7.Written consent to participation.

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

No additional (see E3)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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

Secondary Outcome Measures