Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia

NCT06034561 | Recruiting Phase 2

• 1 other identifier: 4009/23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Lymphoblastic Leukemia, in Relapse; Acute Lymphoblastic Leukemia With Failed Remission

Keywords

Acute lymphoblastic leukemia; Bortezomib; Salvage therapy; Bridge therapy; Response rate

Outcome Measures

Primary Outcomes (1)

• Complete response

  Disappearance of lymphoid blasts in peripheral blood, with fewer than 5% of lymphoid blasts quantified in the bone marrow aspirate through immunophenotyping.

  30 days

Secondary Outcomes (4)

• Event-free survival

  1 year

• Overall survival

  1 year

• Rate of MRD-negativity

  60 days

• Rate of allogeneic hematopoietic stem-cell transplantation

  1 year

Study Arms (1)

Bortezomib

EXPERIMENTAL

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.

Drug: Bortezomib

Interventions

Bortezomib DRUG

Patients should receive one or two courses of this regimen, aiming to achieve complete remission as a bridge to proceed with allogeneic HSCT.

Also known as: Vincristine, Doxorubicin, Peg-asparaginase, Dexamethasone, Methotrexate

Bortezomib

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• Libbs Farmacêutica LTDA: collaborator

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, 01246000, Brazil

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Bortezomib; Vincristine; Doxorubicin; pegaspargase; Dexamethasone; Methotrexate

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Aminopterin; Pterins; Pteridines

Study Officials

• Wellington Silva, MD PhD

  Instituto do Cancer do Estado de Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graziela S Silva

CONTACT

551138934677; graziela.sasilva@hc.fm.usp.br

Bruna Moraes, MSc

CONTACT

551126628112; pesquisa.hematologia@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)