Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Promising combo therapy for infant leukemia enters human trials

NCT ID NCT02553460

Disease control Sponsor: St. Jude Children's Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether adding two adult cancer drugs, bortezomib and vorinostat, to standard chemotherapy is safe and effective for infants with acute lymphoblastic leukemia (ALL). About 50 newly diagnosed infants will receive the combination. The goal is to see if it reduces leukemia cells without causing too many side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bortezomib and vorinostat (cancer drugs) added to standard chemotherapy
What this could lead to
If it works, this could lead to a more effective treatment for infant leukemia, potentially improving survival rates.
What could go wrong
This is an early-phase trial with only 50 infants, so results may not apply broadly. The added drugs could cause serious side effects, and the combination may not work better than standard therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

50 people

The number who actually took part.

Started

Jan 2016

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 365 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * Patients with prior therapy, other than therapy specified in the Inclusion Criteria. * Patients with mature B-cell ALL or acute myelogenous (AML). * Patients with Down syndrome. * Inability or unwillingness of legal guardian/representative to give written informed consent.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute lymphoblastic leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute leukemia of ambiguous lineage acute lymphoblastic leukemia acute undifferentiated leukemia bilineal acute myeloid leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphoblastic leukemia

Contacts and locations

Locations

  • Alberta Children's Hospital

    Calgary, Alberta, T3A 6A8, Canada

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5 CAN, Canada

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1V 4G2, Canada

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

    Vancouver, British Columbia, V6H 3V4, Canada

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital and Clinics of Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

  • Children's Hospital of the King's Daughters (CHKD)

    Norfolk, Virginia, 23507, United States

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California, 94304, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • St. Jude Affiliate-Charlotte

    Charlotte, North Carolina, 28204, United States

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • The Montreal Children's Hospital (MUHC-McGill)

    Montreal, Quebec, H4A 3J1, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.