OPHO ALL-2008 PILOT STUDY ON CONSOLIDATION THERAPY FOR CHILDREN AND YOUNG ADULTS WITH ACUTE LYMPHOBLASTIC LEUKAEMIA - ALL2008p
Phase 1
- Conditions
- Acute lymphoblastic leukemia in children 1.0-18 years of ageMedDRA version: 9.1Level: LLTClassification code 10066109Term: Precursor B-lymphoblastic leukemia acute
- Registration Number
- EUCTR2007-004021-19-DK
- 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
- Secondary Outcome Measures
Name Time Method