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Leukemia drug trial halted early: what we know

NCT ID NCT04817761

Disease control Sponsor: Institut de Recherches Internationales Servier 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a drug called calaspargase pegol in adults aged 22 and older with a specific type of leukemia (Philadelphia-negative ALL). The goal was to find the right dose and check for side effects. The trial was stopped early, but researchers were looking at how the drug worked in the body and any safety issues.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

42 people

The number who actually took part.

Started

Jul 2021

Finished

Mar 2025

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

22 to 55 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: * Aged ≥22 and \<55 years with newly-diagnosed and cytologically confirmed and documented Philadelphia-negative B-cell or T-cell ALL by World Health Organization (WHO) classification (2016). * Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. * No prior therapy for ALL such as chemotherapy and radiation therapy before signing the informed consent except for limited treatment (≤7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine. Exclusion Criteria: * Patients with Philadelphia chromosome positive ALL, Burkitt's leukemia, mixed lineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia per WHO classification (2016). * Patients with Down syndrome. * Patients with Hepatitis B (positive for HBs antigen), and Hepatitis C (HCV antibody) at inclusion * Participants known to be HIV-positive. * Known history of non-gallstone-related pancreatitis. * Known severe hepatic impairment (bilirubin \>3 x upper limit of normal \[ULN\]; transaminases \>10 times ULN. * Pre-existing history of hepatic veno-occlusive disease (VOD). * Age ≥ 55 years. * BMI \> 35 kg/m2.

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Conditions

The condition(s) this trial relates to.

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

  • Baptist Clinical Research Institute

    Memphis, Tennessee, 38120, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute

    Weymouth, Massachusetts, 02190, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • HonorHealth Cancer Transplant Institute

    Scottsdale, Arizona, 85258, United States

  • Intermountain Healthcare (IHC)

    Salt Lake City, Utah, 84143, United States

  • Jefferson Health

    Philadelphia, Pennsylvania, 19107, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • NYU Langone/Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016, United States

  • Northwell Health Cancer Institute

    Lake Success, New York, 11042, United States

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239, United States

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Univeristy of California

    Los Angeles, California, 90095, United States

  • University of California Irvine Health (UCI Health)

    Orange, California, 92868, United States

  • University of Chicago Medicine

    Chicago, Illinois, 60637, United States

  • University of Kansas Cancer Center - Richard and Annette Bloch Cancer Care Pavilion

    Westwood, Kansas, 66205, United States

  • University of Maryland Greenbaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Miami Health System - Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • University of Washington/Seattle Cancer Care Alliance/Fred Hutch

    Seattle, Washington, 98109, United States

  • West Virginia University Cancer Institute

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

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