Clinical trial · Interventional
Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD
Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive Minimal Residual Disease
NCT05137860CI-TRIAL-00056012unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia, in Relapse | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Minimal Residual Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard Care Group
- description
- 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.
- type
- EXPERIMENTAL
- label
- Bortezomib Treatment Group
- description
- 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.
- interventionNames
- Drug: Bortezomib
Primary outcomes (5)
- measure
- Survival Outcome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDBurton 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 8197160
- RESULTBertaina 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 28116786
- RESULTHorton 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 30957229