Phase 2 Leukaemia Trial, Recruiting NCT05289687 Sponsor: Eastern Cooperative Oncology Group Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT05289687
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with T cell acute lymphoblastic leukemia (T cell ALL) and whose cancer has gone into remission (complete or partial) after at least 2 rounds of intensive chemotherapy.
  • People whose cancer is in remission but where sensitive testing still detects a small number of cancer cells at a level of 1 in 10,000 or more (called MRD-positive), confirmed by a central laboratory using a test called flow cytometry.
  • People who have previously had a stem cell transplant from a donor, as long as they do not have a complication called graft-versus-host disease (GVHD) that requires ongoing immune-suppressing medication (low-dose prednisone of 10 mg per day or less may be acceptable — confirm with trial site).
  • People who are reasonably well and able to carry out everyday activities, as measured by a standard medical scale (ECOG score of 0, 1, or 2).
  • People whose blood test results taken within 7 days before registering show that their bone marrow, liver, and kidneys are functioning at an adequate level, as defined by specific laboratory thresholds.
  • People who are HIV-positive and on effective treatment with an undetectable level of virus in the blood within the past 6 months.
  • People with a history of chronic hepatitis B, provided the virus is undetectable on appropriate treatment.
  • People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.
  • People who previously had cancer involvement in the brain or spinal fluid, as long as there is no active involvement at the time of registration.
  • People with a history of another cancer, as long as that cancer or its treatment is not expected to interfere with the safety or results of this trial.
  • People with a history of heart disease or treatment with heart-affecting medications, provided a doctor's assessment rates their heart function as class 2B or better on a standard heart health scale.
  • People who are able to understand and sign a consent form, including those who cannot make decisions for themselves if a legally authorised representative, caregiver, or family member is available to assist.
  • People of childbearing potential who have had a pregnancy test (blood or urine) within 14 days before registering, confirming they are not pregnant.
  • People who agree to use effective contraception or abstain from sex for the entire time they are in the study and for 3 months after the last dose of treatment, and who agree not to donate sperm or eggs during that same period.

Who may not be able to join:

  • People who are currently pregnant or breastfeeding, due to potential harm to an unborn baby or nursing infant from the treatments used in this trial.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Shira Dinner, MD, Northwestern University

Phone: 312-695-6180

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Eastern Cooperative Oncology Group
Registry
ClinicalTrials.gov
Start date
25 May 2023
Est. completion
30 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Complete Remission (CR); Complete Remission (CR); Complete Response with Partial Count Recovery (CRh); Complete Response with Partial Count Recovery (CRh); Complete Remission incomplete (CRi); Complete Remission incomplete (CRi); Minimal Residual Disease Negativity (MRD-); Minimal Residual Disease Negativity (MRD-); Morphologic Relapse; MRD Relapse; Morphologic Relapse; MRD Relapse; Refractory; Refractory

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov