OPHO ALL-2008 Pilot Study on consolidation therapy for children and young adults with acute lymphoblastic leukaemia
Phase 1
- Conditions
- Childhood and adult A
- Registration Number
- EUCTR2007-004021-19-FI
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
B-lineage ALL with a white blood cell count of < 100 x 10E9/l and age at diagnosis 1.0-17.9 yrs, no t(9;22), no hypodiploidy, no 11q23(MLL)-aberrations, no t(1;19), no TPMT deficiency, no known intolerance to MD-MTX and/or oral 6MP and a written consent obtained for 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
If not one of the above is met
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: On an individual toxicity-titrated basis an attemt to increase the dose intensity of the 6-mercaptopurine used in the two-month post-remission treatment phase of lower risk childhood ALL;Secondary Objective: To explore the relationship of the post-high-dose methotrexate consolidation therapy minimal residual disease with the dose of 6-mercaptopurine, thiopurine methyltransferase activity, DNA-6 thioguanine nucleotides, erythrocyte 6 thioguaninen nucleotides, E-MeMP and E-methotrexate.;Primary end point(s): Leukemia-free survival
- Secondary Outcome Measures
Name Time Method