PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

PETHEMA Foundation

Status and phase: Completed; Phase 4

Conditions: Acute Lymphoblastic Leukemia

Treatments: Procedure: Intrathecally treatment; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Methotrexate; Drug: Vincristine; Drug: Daunorubicin; Drug: Asparaginase; Drug: Prednisone; Drug: Mercaptopurine

Study type: Interventional

Funder types: Other

Identifiers

NCT00494897

LAL-RI/96

Details and patient eligibility

About

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.

Full 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.

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:

  • MP 50 mg/m2/day PO
  • MTX 20 mg/m2/week IM

• Reinductions

  • VCR: 1,5 mg/m2 IV, day 1.
  • PDN: 60 mg/m2/day, IV or PO days 1 to 7
  • L-ASA: 20.000 UI/m2, IM or IV day 1.
  • Intrathecally day 1

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).

• MP 50 mg/m2/day, PO
• MTX 20 mg/m2/week, IM.

Enrollment: 374 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)