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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: Asparaginase
* Drug: Cyclophosphamide
* Drug: Cytarabine
* Drug: Daunorubicin
* Drug: Mercaptopurine
* Drug: Prednisone
* Drug: Vincristine
* Drug: Methotrexate
* Procedure: Intrathecally treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Asparaginase|nan|
|Drug: Cyclophosphamide|nan|
|Drug: Cytarabine|nan|
|Drug: Daunorubicin|nan|
|Drug: Mercaptopurine|nan|
|Drug: Prednisone|nan|
|Drug: Vincristine|nan|
|Drug: Methotrexate|nan|
|Procedure: Intrathecally treatment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |