PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 374
- Locations
- 99
- Primary Endpoint
- Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (over 15 years) with ALL standard risk no prior antiblastic chemotherapy
Exclusion Criteria
- •Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t[8;14], t[2;8], t[8;22])
- •Mixed forms of ALL
- •Acute Leukemia no differentiate
- •Patients with coronary disorders, valvular or hypertensive cardiopathy
- •Patients with chronic liver disorders
- •Chronic pulmonary disorders
- •Renal insufficiency
- •Neurologic disfunctions
- •ECOG 3 and 4
- •No signed consent form
Outcomes
Primary Outcomes
Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia
Time Frame: 2 years
Secondary Outcomes
- Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy(2 years)
- To evaluate the treatment tolerance(1 year)