Acute lymphoblastic leukemia in relapse
Conditions
Interventions
Relapsed ALL patients under the age of 71 years will be registered and randomized to receive:
Arm A: prednisone and methotrexate in the pre-phase and thereafter two remission induction courses of alem
Sponsors
Stichting Hemato-Oncologie Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 - 70 years inclusive; 2. First or second relapse of precursor B-ALL or T-ALL (including Philadelphia chromosome or BCR-ABL positive ALL); 3. Duration of last complete remission at least 6 months; 4. WHO performance status 0, 1, or 2; 5. Negative pregnancy test at inclusion if applicable; 6. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Mature B-cell ALL, i.e. Burkitt leukemia/lymphoma; 2. Acute undifferentiated leukemia (AUL); 3. Treatment with alemtuzumab at any time prior to registration; 4. Intolerance of exogenous protein administration; 5. Central nervous system (CNS) leukemia (appendix A); 6. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease); 7. Severe pulmonary dysfunction (CTCAE grade III-IV); 8. Severe neurological or psychiatric disease; 9. Significant hepatic dysfunction (serum bilirubin or transaminases >= 3 times normal level); 10. Significant renal dysfunction (serum creatinine >= 3 times normal level); 11. Patients with active, uncontrolled infections; 12. Patients with uncontrolled asthma or allergy, requiring oral steroid treatment at the time of registration; 13. Patients known to be HIV-positive; 14. Patient is a lactating woman; 15. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients that reach a CR on induction cycle I in each arm; 2. Percentage of patients with severe toxicity on induction cycle I in each arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Toxicity profile related to each treatment step and intervals between treatment steps; 2. 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; 3. Disease-free survival (i.e. time from achievement of CR to date of relapse or death from any cause, whichever occurs first); 4. Overall survival measured from time of registration. | — |
Contacts
Public ContactR. Willemze
Leiden University Medical Center (LUMC), Department of Hematologie (C2-R), P.O. Box 9600
Outcome results
None listed