Bortezomib treatment for relapsed or refractory acute lymphoblastic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II interventional study aims to evaluate the complete response rate of a bortezomib-based salvage regimen in adults suffering from refractory or relapsed acute lymphoblastic leukemia (ALL). The study focuses on patients who have not responded to previous treatments and seeks to provide a potential bridge to allogeneic hematopoietic stem-cell transplantation. By comparing outcomes with existing literature and historical data, the study aims to identify effective treatment strategies for this challenging patient population. The intervention involves administering bortezomib alongside other synergistic drugs to enhance treatment efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto do Cancer do Estado de Sao Paulo
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Wellington Silva, MD PhD — Instituto do Cancer do Estado de Sao Paulo
• Study coordinator: Graziela S Silva
• Email: graziela.sasilva@hc.fm.usp.br
• Phone: 551138934677

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CAR-T cell therapy for adults with relapsed or refractory leukemia and lymphoma

  This study is testing a new CAR-T cell therapy to see if it can help adults with tough-to-treat leukemia or lymphoma feel better and fight their cancer.

  Recruiting at 2 sites Phase 1 Fudan University · Nanchang, Jiangxi and 1 other locations · NCT06445803

• Understanding why CAR T cells don't last in leukemia treatment

  This study looks at kids and young adults with leukemia to see why CAR T cells don't stick around long enough after treatment and what might help them last longer.

  Recruiting at 3 sites University College, London · London and 2 other locations · NCT05809284

• Venetoclax treatment for high-risk blood cancers in young patients

  This study is testing a new combination of a drug called venetoclax with chemotherapy to see if it helps young patients with high-risk blood cancers feel better while keeping side effects low.

  Recruiting at 5 sites Phase 1 Dana-Farber Cancer Institute · San Francisco, California and 4 other locations · NCT05292664

• Point-of-care MB-CART19.1 CAR-T therapy for relapsed or refractory B‑ALL

  This will test whether autologous, point-of-care manufactured CD19-directed CAR-T cells (MB-CART19.1) can treat children and adults with relapsed or refractory B‑cell acute lymphoblastic leukemia.

  Recruiting King Hussein Cancer Center · Amman · NCT07371403

• Nanobody CD5 CAR‑T for relapsed or refractory CD5‑positive T‑cell cancers

  This will test a CD5-targeted CAR‑T cell treatment using patients' own or donor-derived cells to try to help people with relapsed or refractory CD5+ T‑cell leukemias and lymphomas.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT07070323

• CIK cell therapy for relapsed or refractory B‑cell acute lymphoblastic leukemia with early CAR‑T dysfunction

  We are testing whether giving regular or mRNA‑modified CIK cells helps children and young adults with relapsed or refractory B‑cell ALL who show early CAR‑T cell exhaustion stay free of relapse or disease progression longer.

  Recruiting Beijing GoBroad Hospital · Beijing, Beijing Municipality · NCT06389305

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.