Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia. Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.

Official Title
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Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.

Conditions
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Leukemia

Intervention / Treatment
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* Drug: asparaginase
* Drug: daunorubicin hydrochloride
* Drug: etoposide
* Drug: idarubicin
* Drug: imatinib mesylate
* Drug: mercaptopurine
* Drug: methotrexate
* Drug: methylprednisolone
* Drug: mitoxantrone hydrochloride
* Drug: prednisone
* Drug: vincristine sulfate
* Procedure: allogeneic hematopoietic stem cell transplantation
* Procedure: autologous hematopoietic stem cell transplantation
* Procedure: peripheral blood stem cell transplantation
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria: Negative myeloperoxidase stain Phenotype T (T-ALL) or B (B-ALL) No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl transferase-negative) PATIENT CHARACTERISTICS: Creatinine ≤ 2.5 mg/dL (after adequate hydration) SGOT and SGPT ≤ 3 times upper limit of normal LVEF ≥ 50% No severe psychiatric disorders No other concurrent malignant disease No presence of documented infections not responding to antibiotic and/or antifungal therapy Not pregnant PRIOR CONCURRENT THERAPY: No prior steroids No prior antiblastic chemotherapy No other concurrent chemotherapy or radiotherapy

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: asparaginase|nan|
|Drug: daunorubicin hydrochloride|nan|
|Drug: etoposide|nan|
|Drug: idarubicin|nan|
|Drug: imatinib mesylate|nan|
|Drug: mercaptopurine|nan|
|Drug: methotrexate|nan|
|Drug: methylprednisolone|nan|
|Drug: mitoxantrone hydrochloride|nan|
|Drug: prednisone|nan|
|Drug: vincristine sulfate|nan|
|Procedure: allogeneic hematopoietic stem cell transplantation|nan|
|Procedure: autologous hematopoietic stem cell transplantation|nan|
|Procedure: peripheral blood stem cell transplantation|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Reaching Disease Free Survival |  | At 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Reaching Complete Hematological Response After Induction Therapy |  | At the end of induction, day +50 | 
| Percentage of Participants Reaching Overall Survival | Overall survival from diagnosis | At 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-cell adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, L1 adult acute lymphoblastic leukemia, L2 adult acute lymphoblastic leukemia, TdT positive adult acute lymphoblastic leukemia