Clinical study in children 1-19 years on maintenance therapy for acute lymphoblastic leukemia
- Conditions
- Pediatric acute lymphoblastic leukemiaTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2016-003409-33-FI
- Lead Sponsor
- Queen Silvias Childrens and Adolescents Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
All children with standard or intermediate risk acute lymphoblastic leukemia, aged 0-18 years at time of diagnosis of leukemia and treated according to ALL2008 protocols and with TPMT wild type who start maintenance 2 phase are eligible.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
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
-Mature B celL lymphoblastic leukemia; t(9;22) positive acute lymphoblastic leukemia
-Unknown TPMT status or presence of TPMT mutation (both heterozygous and homozygous)
-Known intolerance to any of the chemotherapeutic drugs in the protocol
-Major organ failure precluding administration of planned chemotherapy
-Sever liver toxicity defined as persistent (= two weeks) elevation of either S-bilirubin > 50 ??mol/l or S-GPT > 20 x UNL (upper normal limit) or P-Protrombin complex > 1.5
-Reduced kidney function defined as S creatine = 2 x UNL
-Lactating female or female of childbearing potential not using adequate contraception
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