Phase 2 Leukaemia Trial, Recruiting NCT04746209 Sponsor: Medical College of Wisconsin Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT04746209
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 B-cell acute lymphoblastic leukemia (a type of blood cancer) where testing of the bone marrow shows no detectable cancer cells remaining (less than 0.01%), AND who fall into at least one of these groups: their cancer came back and then went into remission again; they have a very high-risk form of the disease heading toward a stem cell transplant in their first remission; or low but detectable levels of cancer were still found at the end of an early treatment phase.
  • People who have a suitable donor available — either an unrelated donor or a partially matched family member (haploidentical donor).
  • People aged 25 or younger at the time of joining the study.
  • People who have a reasonable level of physical functioning, measured by standard scoring scales used for their age group (confirm with trial site).
  • People whose heart, lungs, liver, kidneys, and nervous system are functioning well enough to meet specific medical thresholds, confirmed by tests done within 14 days of registration.
  • People whose cancer came back after a previous stem cell transplant may still be eligible, provided there are no signs of a transplant-related immune reaction (called graft-versus-host disease) and all transplant immune-suppressing medications have been stopped for at least 7 days.
  • People who have completed other immune-based treatments (such as CAR T-cell therapy or cancer vaccines) at least 42 days before joining, not including a specific drug called blinatumomab.
  • People who had prior radiation to the brain or spine at least 90 days before joining, and who will not receive that type of radiation during the study.
  • People who are sexually active and able to become pregnant, or who could father a child, and who agree to use appropriate contraception during treatment and for 2 months afterward.
  • People (or their guardians) who are willing and able to give voluntary written consent to participate.
  • People who have already been enrolled in a related study called the Blinatumomab Bridging Therapy (BBT) Trial.

Who may not be able to join:

  • People whose cancer has spread outside the bone marrow, or who have tumor masses forming in tissues (sometimes called chloromas).
  • People currently receiving other cancer treatments not specified by this study's plan.
  • People who have an active infection (bacterial, viral, fungal, or other) that is not yet under control despite appropriate treatment; people with a possible fungal infection must have completed at least 2 weeks of antifungal treatment and have no remaining symptoms.
  • People who are pregnant or breastfeeding, as the treatments used carry known risks to a fetus; a pregnancy test is required within 7 days before registration for anyone who could become pregnant.
  • People who have a known allergy to any of the medications used in this study.
  • People who are currently participating in another Phase 1 or Phase 2 clinical treatment study.
  • People who have another active cancer in addition to B-cell acute lymphoblastic leukemia.

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 12 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: Rachel Phelan, MD, MPH, Medical College of Wisconsin

Phone: 414-266-5891

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
Medical College of Wisconsin
Registry
ClinicalTrials.gov
Start date
1 February 2021
Est. completion
28 February 2024

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percentage of patients who are able to receive the blinatumomab infusion [Feasibility]

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: 12 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