findmyKOL
Clinical trialNCT02553460Active, not recruitingPhase 1/PHASE2Interventional

Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

SponsorSt. Jude Children's Research HospitalEnrollment50Acute Lymphoblastic Leukemia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Alberta Children'S Hospital

    Calgary, Alberta, Canada

  • Stollery Children'S Hospital

    Edmonton, Alberta, Canada

  • Children'S & Women'S Health Centre of British Columbia

    Vancouver, British Columbia, Canada

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, Canada

  • the Montreal Children'S Hospital (muhc-Mcgill)

    Montreal, Quebec, Canada

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, Canada

United States
  • Children'S Hospital Los Angeles

    Los Angeles, California, United States

  • Children'S Hospital of Orange County

    Orange, California, United States

  • Lucile Packard Children'S Hospital Stanford University

    Palo Alto, California, United States

  • Children'S Hospital and Clinics of Minnesota

    Minneapolis, Minnesota, United States

  • St. Jude Affiliate-Charlotte

    Charlotte, North Carolina, United States

  • Cincinnati Children'S Hospital

    Cincinnati, Ohio, United States

  • Oregon Health and Science University

    Portland, Oregon, United States

  • St. Jude Children'S Research Hospital

    Memphis, Tennessee, United States

  • Children'S Hospital of the King'S Daughters (chkd)

    Norfolk, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Jan 2016
Primary completion
10 May 2022
Completion
31 Oct 2031
Last update posted
24 Jun 2026
Registered enrollment
50
Registry id
NCT02553460

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.