acute lymphoblastic leukemia relapse refractory children
Conditions
Interventions
The patients will be treated with bortezomib (1.3 mg/m2/dose twice weekly (days 1 and 4 of each week) for a total of 2 weeks. Group A will get bortezomib on days 1, 4, 8 and 11, while group B will get
Sponsors
Erasmus MC, Rotterdam, Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 6 months and 19 years; 2. Patients with a second or subsequent relapsed ALL; 3. Patients with first relapsed ALL after prior allogeneic stem cell transplantation in first complete remission; 4. Patients with refractory first relapse of ALL, as defined by the ALL relapse protocol these patients were enrolled in; 5. Circulating leukemic blasts of at least 100/ul peripheral blood (i.e. at least 0.1x109/l); 6. Patients must take adequate contraceptives when of childbearing potential; 7. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Relapse not involving bone marrow; 2. Symptomatic CNS leukemia; 3. Active uncontrolled infection; 4. Performance status (Lansky or Karnofsky score) of 60% or less; 5. Life expectancy of less than 6 weeks; 6. Existing peripheral neuropathy NCI grade 2 or higher; 7. Presence of acute diffuse infiltrative and/or pericardial disease; 8. Existing clinical signs of cardiotoxicity; 9. Previous allogeneic stem cell transplantation within 100 days; 10. Pregnant or breastfeeding; 11. Other contra-indications for chemotherapy, including no recovery from previous treatment; 12. Previous exposure to bortezomib; 13. Other experimental or conventional antileukemic treatment within 7 days from start of bortezomib; 14. Allergy to boron and its metabolites; 15. Concomitant anti-leukemic therapy other than according to this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the antileukemic activity of combination chemotherapy including bortezomib as reinduction therapy in childhood relapsed/refractory ALL. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Determine the feasibility and safety of combining bortezomib with conventional combination chemotherapy in children and adolescents with relapsed/refractory ALL; 2. Evaluate bortezomib levels and proteasome inhibition in cerebrospinal fluid, bone marrow and peripheral blood in patients with relapsed/refractory ALL, and assess the relationship to the efficacy and toxicity of bortezomib. | — |
Contacts
Public ContactC.M. Zwaan
Dept. of Pediatric Oncology-Hematology Erasmus MC-Sophia Children's Hospital POB 2060
Outcome results
None listed