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Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia

NCT06034561 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-16

No results posted yet for this study

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

Interventions

DRUG

Bortezomib

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

Sponsors & Collaborators

  • Libbs Farmacêutica LTDA

    collaborator INDUSTRY

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Wellington Silva, MD PhD · Instituto do Cancer do Estado de Sao Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2028-08-31
Completion
2029-08-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06034561 on ClinicalTrials.gov