Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD

Study Overview
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Brief Summary
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Various drugs have been added to different treatment regimens in order to improve the response rate in patients with Acute Lymphoblastic Leukemia, however, it has been shown that adding Bortezomib to the relapsing regimen improves the proportion of second complete remissions without increasing chemotherapy toxicity. Therefore, proteasome inhibitors can drastically modify the prognosis of patients, since their synergy with drugs such as steroids has positioned them as an attractive strategy.

Detailed Description
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Mortality associated with leukemia has decreased due to the use of various chemotherapy combinations, the addition of new agents, or the chemical modification of existing drugs. Despite advances in treatment, the prognosis in the adult population continues to be unfavorable. About 25% of the patients will be refractory to the first treatment regimen and the rest will have a disease-free survival below 40%. The chemotherapy intensity reduction strategy based on risk stratification according to Minimal Residual Disease (MRD) is a strategy used by various pediatric centers in order to detect patients at high risk of relapse.

Official Title
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Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive Minimal Residual Disease

Conditions
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Acute Lymphoblastic Leukemia, in Relapse, Chemotherapeutic Toxicity, Minimal Residual Disease

Intervention / Treatment
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* Drug: Bortezomib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a confirmatory diagnosis of Acute Lymphoblastic Leukemia relapsed to bone marrow described with more than 5% blasts in bone marrow at any stage of treatment or positivity of minimal residual disease at any stage of treatment. Patients who have signed their informed consent from the institution for hospitalization, and accepted the performance of the bone marrow study, and the administration of chemotherapy. Exclusion Criteria: Patients with a diagnosis of phenotypic leukemia or bilinear leukemia Patients treated only with palliative regimen or transfusion support Patients without the administration of prophylaxis to the central nervous system by intrathecal chemotherapy Patients with lymphoblastic leukemia with a positive Philadelphia chromosome Patients with severe comorbidities may put treatment therapy at risk. Patient with a history of cardiac toxicity or arrhythmias associated with treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinical Randomized Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care Group<br>Each patient will receive their standard chemotherapy treatment for patients with relapsed Acute Lymphoblastic Leukemia based on the HyperCVAD scheme for a period of 12 weeks. Each chemotherapy cycle will be monitored by the health team corresponding to the Hematology service and the principal investigator. | |
| Experimental: Bortezomib Treatment Group<br>Each patient will receive their standard chemotherapy treatment for patients with relapsed Acute Lymphoblastic Leukemia based on the HyperCVAD scheme in combination with Bortezomib for a period of 12 weeks. Each chemotherapy cycle will be monitored by the health team corresponding to the Hematology service and the principal investigator. | Drug: Bortezomib<br>* Combination of Bortezomib with Standard Chemotherapy scheme for acute lymphoblastic patients in relapse.<br>* Other names: Intervention Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Outcome | The event in which patient is discharge from Hospital stay. | 3 months | 
| Hospital stay | Time in which patients stay in the Hospital before discharge | 3 months | 
| Leukocytes count | Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle | 3 months | 
| Platelets count | Number of platelets found in peripheral blood at the end of each chemotherapy cycle | 3 months | 
| Date of Remission | Time in which the patient completes remission | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute lymphoblastic leukemia, Bortezomib, Relapse, Minimal Residual Disease, Toxicity