Acute lymphoblastic leukemia MedDRA version: 9.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia
Conditions
Interventions
Trade Name: Methotrexate
Product Name: Methotrexate
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Methotrexate
CAS Number: 59-05-2
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Non-B ALL. 2. Non-Ph+ ALL. 3. Age 1.0-17.9 years. 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
Exclusion criteria: 1. Bilineage ALL. 2. Pre-treatment with glucocorticosteroids or other antileukemic agents. Patients, who have been treated with systemic glucocorticosteroids or other anticancer agents (e.g. methotrexate or thiopurines) for more than a week prior to the diagnosis of ALL and initiation of antileukemic therapy, can be treated by the NOPHO ALL-2008 protocol and will be registered, but they cannot be included in the randomised trials. 3. Incomplete exploration for the risk group stratifying cytogenetic aberrations. 4. ALL predisposition syndromes. Patients with certain ALL-predisposing disorders (e.g. Down syndrome, Ataxia Telangiectasia) can be entered into the protocol with the amendments outlined in section 16, but can not be included in the randomised trials. 5. Previous cancer. Patients who have previously been treated for a malignant neoplasm can be treated by the NOPHO ALL-2008 protocol and will be registered, but they cannot be included in the randomised trials (see section 16). They will be treated according to the control arms of the protocol. 6. Intolerance to one or more anticancer agent. 7. Administration of additional chemotherapy during induction therapy for non-HR ALL. Patients with non-HR ALL, who at day 15 have a M3 bone marrow should not be given additional chemotherapy. If given, the patients will not be eligible for the SR-ALL treatment arm and the patient will not be eligible for randomisation. 8. Sexually active females not using contraception. 9. TPMT-deficiency (6MP-randomisation only). 10. DepoCyte during induction therapy (DepoCyte randomisation only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We will additionally measure EFS and toxicity as secondary end points of effect. 2. To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed. 3. To test if replacing six doses of conventional triple i.t. therapy with DepoCyte® during maintenance therapy for HR-ALL will yield an equal or reduced rate of serious toxicity (SAEs and SUSARs) with a similar or decreased CNS- and overall relapse rate. ;Secondary Objective: ;Primary end point(s): A. Reduction of relapse rate and/or level of residual disease without an unacceptable increase in toxicitý. OR B. Equal rate of relapse with a reduction of rate of significant toxicities | — |
Countries
Denmark, Finland, Iceland, Lithuania, Sweden
Outcome results
None listed