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

Sponsor

Hospital General de Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT05137860

Collaborator

(none)

Enrollment

Location

Arms

18.3

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia, in Relapse Chemotherapeutic Toxicity Minimal Residual Disease	Drug: Bortezomib	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Clinical Randomized TrialClinical Randomized Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 12, 2021

Anticipated Primary Completion Date :

Dec 22, 2022

Anticipated Study Completion Date :

Jun 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard Care Group 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 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 Combination of Bortezomib with Standard Chemotherapy scheme for acute lymphoblastic patients in relapse. Other Names: Intervention Group

Arm

Intervention/Treatment

No Intervention: Standard Care Group

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

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

Combination of Bortezomib with Standard Chemotherapy scheme for acute lymphoblastic patients in relapse.

Other Names:

Intervention Group

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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