LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

Study Overview
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Brief Summary
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Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.

Detailed Description
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Remission Induction: Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8. Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14 L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13 Results: 1. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks 2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C Intrathecal chemotherapy: Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22 CONSOLIDATION TREATMENT 1 Start in two weeks after last dose of induction chemotherapy: Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63 Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56. VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42 ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43 Intrathecal treatment, days 28 and 56. 6.4. CONSOLIDATION TREATMENT 2 Start in a week after last dose of mercaptopurine of previous cycle Dexamethasone (DXM): 10 mg/m2 day, p.o. or i.v. days 1-14 5 mg/m2 day, p.o. or i.v., days 15-21 Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15 Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9. CFM 600 mg/m2 day, i.v., days 1 and 15 L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17 Intrathecal treatment days 1 and 15. TRANSPLANTATION Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment. Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1 Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching

Official Title
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LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: Vincristine
* Drug: Daunorubicin
* Drug: Prednisone
* Drug: L-Asparaginase
* Drug: Mitoxantrone
* Drug: Cytosine Arabinoside
* Drug: Hydrocortisone
* Drug: Mercaptopurine
* Drug: Cyclophosphamide
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ALL BCR/ABL+ patients Age < 65 years No previous treatment Exclusion Criteria: Other LLA variability Previous history of coronary valvular, hypertensive cardiopathy illness Chronic hepatic illness Chronic respiratory insufficiency Renal insufficiency not caused by LLA Severe neurological problems not caused by LLA Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA

Ages Eligible for Study
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Maximum Age: 65 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: Vincristine|1,5 mg/m2 i.v., days 1 and 8|
|Drug: Daunorubicin|60 mg/m2, i.v., days 1 and 8|
|Drug: Prednisone|60 mg/m2 day, i.v. or oral, days 1 to 14|
|Drug: L-Asparaginase|10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.|
|Drug: Mitoxantrone|12 mg/m2 i.v days 15, 16 and 17|
|Drug: Cytosine Arabinoside|1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)|
|Drug: Hydrocortisone|10 mg ,15 mg or 20 mg depending of age|
|Drug: Mercaptopurine|50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation|
|Drug: Cyclophosphamide|600 mg/m2 day, i.v., days 1 to 15 in consolidation|
|Drug: Dexamethasone|10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lymphoblastic Leukemia, Chromosome Philadelphia positive