Glivec in Ph Positive Lymphoblastic Leukemia

Study Overview
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Brief Summary
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% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment

Detailed Description
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Pilot phase II clinical trial, prospective, multicentric and opened

Official Title
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Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant

Conditions
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Acute Lymphoblastic Leukemia, Cromosome Philadelphia Positive

Intervention / Treatment
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* Drug: chemotherapy
* Drug: Glivec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New diagnosis LLA Ph+ (BCR/ABL) patients ≤ 65 years old Fertile age women must do a pregnancy test in the 7 days previous at the beginning of clinical trial medication Performance status 0-2 (Appendix B); Is allowed performance status > 2 because of LLA Patients without organ alteration: hepatic function: global bilirubin, AST, ALT, gamma-GT and alkaline phosphatase less than 2 times LSN; renal function: Creatinine < 1,5 mg/dl o Clearance creatinine > 60 ml/min; anormal renal function caused by LLA ; normal heart function (Appendix B): FEV > 50%; No Chronic respiratory illness. If the anormal values are secondary of the experimental illness the investigator can decide himself if the patient can be included at the clinical trial. Negative HIV serology Written, oral or with witness informed consent. In patients < 18 years old must be signed written and legal representative informed consent. No experimental chemotherapy or other experimental treatment. Allowed to begin induction chemotherapy from the diagnosis to confirm Ph. No major surgical process in the previous 14 days of the treatment Start. 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 Pregnancy and women Blastic crisis LMC

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: chemotherapy|nan|
|Drug: Glivec|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment. |  |  | 
| Discover if is possible to treat patients with Glivec plus Standard consolidation treatment. |  |  | 
| Discover the Glivec effect over ERM during consolidation treatment and alter transplant |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute lymphoblastic Leukemia