Acute Lymphoblastic Leukemia Cancer Lymphoid leukaemia
Conditions
Interventions
Patients will be treated with the following courses:
1. Pre-induction course consisting of Ara-C 200 mg/m2/day, 2 days, etoposide 120 mg/m2/day, 2 days, MTX 500 mg/m2/day, 2 days and leucovorin.
2. 2
Sponsors
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 40 - 70 years inclusive 2. Primary previously untreated ALL* 3. WHO performance status 0, 1, or 2 4. Negative pregnancy test at inclusion if applicable 5. Written informed consent *Patients with mediastinal mass defining the so-called T-lymphoblastic leukemia/lymphoma are eligible for this trial. ALL patients with Philadelphia chromosome - t(9;22) and variants - are also eligible for this trial. However, when an alternative trial for Philadelphia chromosome positive patients becomes available, patients should be included in that trial by preference.
Exclusion criteria
Exclusion criteria: 1. Mature B-cell ALL, i.e. Burkitt leukemia/lymphoma 2. Acute undifferentiated leukemia (AUL) 3. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease) 4. Severe pulmonary dysfunction (Common Terminology Criteria for Adverse Events [CTCAE] grade III-IV) 5. Severe neurological or psychiatric disease 6. Significant hepatic dysfunction (serum bilirubin or transaminases = 3 times normal level) except when caused by leukemic infiltration 7. Significant renal dysfunction (serum creatinine = 3 times normal level after rehydration and correction of hyperuricemia) 8. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma 9. History of anthracycline use exceeding a cumulative dose of 300 mg/m2 doxorubicin (or its biological equivalent) 10. Active, uncontrolled infections 11. Patient known to be HIV-positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (i.e. time from achievement of complete response [CR] to day of relapse or death from any cause, whichever comes first) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CR rate after remission induction and consolidation 2. Toxicity profile related to each treatment step and intervals between treatment steps 3. Event-free survival (i.e. time from registration until no CR on protocol, relapse or death, whichever comes first); Event-free survival for patients without a CR is set at one day 4. Overall survival measured from time of registration 5. Outcome of patients with a reduced intensity conditioning allogeneic stem cell transplantation | — |
Countries
Belgium, Netherlands
Outcome results
None listed