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New immunotherapy combo aims to stop relapse in young blood cancer patients

NCT ID NCT04972942

Disease control Sponsor: New York Medical College Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This early-phase trial tests whether adding daratumumab (an immunotherapy drug) after a stem cell transplant can safely help control high-risk T-cell acute lymphoblastic leukemia or lymphoma in children, teens, and young adults up to age 39. About 30 participants will receive the drug after standard transplant preparation. The main goal is to check for serious side effects, while also tracking how well the treatment prevents the cancer from coming back.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Sep 2028

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 39 years

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: * 0-39yrs * T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy (including secondary malignancy) * Planned allogeneic stem cell transplantation with donor identified * Performance status ≥ 60% * Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study * Meet organ function requirements * Signed IRB approved informed consent Exclusion Criteria: * May not have had a prior autologous or allogenic stem cell transplant * May not have uncontrolled, systemic infection at the time of enrollment * Known allergies, hypersensitivity, or intolerance to mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients * Must not be pregnant or actively breast feeding * Seropositive for HIV, hepatitis B or hepatitis C * COPD * Asthma * Clinically significant cardiac disease

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Conditions

The condition(s) this trial relates to.

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma T-cell acute lymphoblastic leukemia T-lymphoblastic lymphoma

As listed by the trial registrant

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

T-cell acute lymphoblastic leukemia T-cell acute lymphoblastic lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Colordao

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's National Medical Center

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Helen DeVos Children's Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • John Hopkins All Children's Hospital

    NOT_YET_RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Loma Linda University Children's Hospital

    RECRUITING

    Loma Linda, California, 92354, United States

  • MD Anderson Cancer Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Medical College of Wisconsin

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Nationwide Children's Hosptial

    NOT_YET_RECRUITING

    Columbus, Ohio, 43205, United States

  • New York Medical College

    RECRUITING

    Vallhala, New York, 10595, United States

  • Phoenix Children's Hospital

    NOT_YET_RECRUITING

    Phoeniz, Arizona, 85016, United States

  • Riley Children's Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • University of California

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • University of California

    RECRUITING

    San Francisco, California, 94143, United States

    Contact Email: •••••@•••••

  • University of Florida

    RECRUITING

    Gainsville, Florida, 32608, United States

More trials for these conditions

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