Clinical trial · Interventional
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia in Adults
NCT06034561CI-TRIAL-00089826recruitingPhase 2ClinicalTrials.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)
This is a interventional phase II study aiming to examine the complete response rate of a bortezomib-based salvage regimen in adults with refractory or relapsed acute lymphoblastic leukemia (ALL), seeking to compare outcomes with the available literature and with our historical data on relapsed/refractory ALL.
Conditions
Conditions (2)
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 |
| Acute Lymphoblastic Leukemia With Failed Remission | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib
- description
- Patients with refractory or relapsed acute lymphoblastic leukemia will receive one-two courses of salvage regimen composed by: * Bortezomib 1.3 mg/m2 I.V. D1,D4,D8,D11; * Vincristine 1.5 mg/m2 I.V. (maximum at 2 mg) - D1, D8,D15,D22; * Doxorubicin 60 mg/m2 I.V. - D1; * Peg-asparaginase 2000 IU/m2 I.V. - D4 and D18; * Dexamethasone 20 mg/m2 P.O. or I.V. (divided BID) - D1-D5 and D15-D19 * Intrathecal chemotherapy: methotrexate 12 mg + dexamethasone 2 mg.
- interventionNames
- Drug: Bortezomib
Primary outcomes (1)
- measure
- Complete response
- timeFrame
- 30 days
- description
- Disappearance of lymphoid blasts in peripheral blood, with fewer than 5% of lymphoid blasts quantified in the bone marrow aspirate through immunophenotyping.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients between 16 and 60 years-old with refractory or relapsed ALL (≥1% of anomalous blasts by flow cytometry in bone marrow or peripheral blood) after one or two lines of therapy, regardless of their phenotype or baseline genetic alteration; * Patients are eligible after allogeneic HSCT as long as patients are not actively being treated for graft-versus-host-disease (GvHD). Exclusion Criteria: * Burkitt leukemia; * Prior myeloproliferative disease; * Drug allergies; * Eastern Cooperative Oncology Group (ECOG) scale \>2; * Total bilirubin\>2x upper limit of normal (ULN); * Transaminases\>5x ULN; * Creatinine\>2,5 mg/dl; * Active uncontrolled infection; * History of asparaginase-induced pancreatitis; * Prior exposure to bortezomib; * Heart failure New York Heart Association (NYHA) Class III or IV; * Patients with more than 400mg/m2 lifetime exposure of anthracycline; * Severe psychiatric disorder which prevents adequate compliance; * Refusal to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.