A Phase 4 interventional study of Asparaginase and Cyclophosphamide in Acute Lymphoblastic Leukemia, sponsored by PETHEMA Foundation. Completed at 87 sites in Spain. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2009-05-19.
Sponsored by PETHEMA Foundation · Phase 4, Interventional, and Treatment
The objective of current protocol is try improve the results of chemotherapy treatment in patients with ALL wich is not indicated the peripheral stem cell transplant in first remission, with an intensive consolidation follow by re-inductions.
Induction therapy:
Patients with standard risk receive vincristine (1,5 mg/m2)IV on days 1, 8, 15 and 22;daunorubicin (30 mg/m2)IV on days 1, 8, 15 and 22; oral or IV prednisone 60 mg/m2/day, days 1 to 27 and 30 mg/m2/day, days 28 to 35;asparaginase 10.000 UI/m2 IM or IV, days 10 to 12, 17 to 19 and 24 to 26;cyclophosphamide (500 mg/m2)IV days 1, 2 and 29; methotrexate, cytosine arabinoside and hydrocortisone, days 1 to 22.
Patients older than 55 years are not treated with asparaginase and cyclophosphamide.
Consolidation therapy (1):
Standard risk: Mercaptopurine 50 mg/m2, PO, days 1 to 7, 28-35 and 56-63; methotrexate (3g/m2)IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV, days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.
Patients over 50 years: Mercaptopurine (50 mg/m2), PO, days 1 to 7, 28-35 and 56-63;methotrexate (1,5 g/m2) IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.
Consolidation therapy (2)/Reinduction: one cycle similar to induction. It starts one week after last dose of mercaptopurine.Dexamethasone 10 mg/m2/day,PO or IV, days 1-14 and 5 mg/m2/day, PO or IV days 15-21; VCR: 1,5 mg/m2 IV, days 1, 8 and 15; Daunorubicin 30 mg/m2 IV, days 1, 2, 8 and 9; cyclophosphamide 600 mg/m2/day IV, days 1 and 15; Asparaginase: 10.000 UI/m2 IM or IV, days 1-3 and 15-17;intrathecally treatment days 1 and 15
Maintenance therapy 1:administration of continuous chemotherapy (mercaptopurine and methotrexate) and reinductions until one year from diagnosis.
Continuous chemotherapy:
Reinductions
Seven cycles, weeks 25, 29, 33, 37, 41, 45 and 49.
Maintenance therapy 2:administration of continuous chemotherapy (mercaptopurine and methotrexate) while second year from diagnosis (weeks 53 to 104).
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 374 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →PETHEMA Foundation is the lead sponsor of 104 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia
Time frame: 2 years
Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy
Time frame: 2 years
To evaluate the treatment tolerance
Time frame: 1 year
This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.
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