Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia in Adults
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 60
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Brazil
Instituto do Cancer do Estado de Sao Paulo
RECRUITING
São Paulo
Contact Information
Primary
Graziela S Silva
graziela.sasilva@hc.fm.usp.br
551138934677
Backup
Bruna Moraes, MSc
pesquisa.hematologia@hc.fm.usp.br
551126628112
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2029-08
Participants
Target number of participants: 50
Treatments
Experimental: Bortezomib
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.
Related Therapeutic Areas
Sponsors
Leads: Instituto do Cancer do Estado de São Paulo
Collaborators: Libbs Farmacêutica LTDA