Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2021
CompletedFirst Posted
Study publicly available on registry
November 30, 2021
CompletedStudy Start
First participant enrolled
December 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2023
CompletedJanuary 18, 2022
January 1, 2022
1 year
November 16, 2021
January 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (2)
Standard Care Group
NO INTERVENTIONEach 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.
Bortezomib Treatment Group
EXPERIMENTALEach 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.
Interventions
Combination of Bortezomib with Standard Chemotherapy scheme for acute lymphoblastic patients in relapse.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General de México "Dr. Eduardo Liceaga"
Mexico City, 06720, Mexico
Related Publications (3)
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. doi: 10.1073/pnas.91.11.4935.
PMID: 8197160BACKGROUNDBertaina 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 lymphoblastic leukaemia of childhood. Br J Haematol. 2017 Feb;176(4):629-636. doi: 10.1111/bjh.14505. Epub 2017 Jan 24.
PMID: 28116786RESULTHorton 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):274-285. doi: 10.1111/bjh.15919. Epub 2019 Apr 7.
PMID: 30957229RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adolfo Martinez Tovar, PhD
Hospital General de Mexico
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 16, 2021
First Posted
November 30, 2021
Study Start
December 12, 2021
Primary Completion
December 22, 2022
Study Completion
June 23, 2023
Last Updated
January 18, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.