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

Chemotherapeutic Toxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05137860
• Other study ID #: HGMDI/21/204/03/67
• Status: Recruiting
• Phase: Phase 4
• Start date: December 12, 2021
• Est. completion date: June 23, 2023

Study information

• Verified date: January 2022
• Source: Hospital General de Mexico
• Contact: Christian O Ramos Peñafiel, PhD
• Phone: +52 55 27892000
• Email: leukemiachop[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: June 23, 2023
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, in Relapse
• Chemotherapeutic Toxicity
• Leukemia
• Leukemia, Lymphoid
• Minimal Residual Disease
• Neoplasm, Residual
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital General de México "Dr. Eduardo Liceaga"	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Bertaina A, Vinti L, Strocchio L, Gaspari S, Caruso R, Algeri M, Coletti V, Gurnari C, Romano M, Cefalo MG, Girardi K, Trevisan V, Bertaina V, Merli P, Locatelli F. The combination of bortezomib with chemotherapy to treat relapsed/refractory acute lymphob — View Citation

Burton JD, Bamford RN, Peters C, Grant AJ, Kurys G, Goldman CK, Brennan J, Roessler E, Waldmann TA. A lymphokine, provisionally designated interleukin T and produced by a human adult T-cell leukemia line, stimulates T-cell proliferation and the induction of lymphokine-activated killer cells. Proc Natl Acad Sci U S A. 1994 May 24;91(11):4935-9. — View Citation

Horton TM, Whitlock JA, Lu X, O'Brien MM, Borowitz MJ, Devidas M, Raetz EA, Brown PA, Carroll WL, Hunger SP. Bortezomib reinduction chemotherapy in high-risk ALL in first relapse: a report from the Children's Oncology Group. Br J Haematol. 2019 Jul;186(2) — View Citation

Outcome

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