NCT02553460Active, not recruitingPhase 1/2
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease the number of leukemia cells, but it could also cause additional side effects. Bortezomib and vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other cancers in adults, but they have not been approved for treating children with leukemia. With this research, we plan to meet the following goals: PRIMARY OBJECTIVE: * Determine the tolerability of incorporating bortezomib and vorinostat into an ALL chemotherapy backbone for newly diagnosed infants with ALL. SECONDARY OBJECTIVES: * Estimate the event-free survival and overall survival of infants with ALL who are treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone. * Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR. * Compare end of induction, end of consolidation, and end of reinduction MRD levels to Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant outcomes.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 16 Sept 2015
- Start date
- 29 Jan 2016
- Primary completion date
- 10 May 2022
- Lead sponsor
- St. Jude Children's Research Hospital
- NCT number
- NCT02553460
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 50
- From 29 Jan 2016 to the primary completion date, 10 May 2022
- 15 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with prior therapy, other than therapy specified in the Inclusion Criteria.
Other illness
- Patients with Down syndrome.
Other
- Patients with mature B-cell ALL or acute myelogenous (AML).
- Inability or unwillingness of legal guardian/representative to give written informed consent.
Who the study is looking for
- Patient is ≤ 365 days of age at the time of diagnosis.
- Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid.
- Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy.
- Written informed consent following Institutional Review Board, NCI, FDA, and Office for Human Research Protections (OHRP) Guidelines.
Age in the registry: - to 365 days · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alberta Children's Hospital Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Stollery Children'S Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| The Montreal Children's Hospital (MUHC-McGill) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centre Hospitalier Universitaire Sainte-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centre hospitalier universitaire de Québec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Children's & Women's Health Centre of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| St. Jude Affiliate-Charlotte Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Cincinnati Children's Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Children's Hospital and Clinics of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Children's Hospital of the King's Daughters (CHKD) Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Children's Hospital of Orange County Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Lucile Packard Children's Hospital Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.