Phase 2 Leukaemia Trial, Recruiting NCT07222579 Sponsor: West Virginia University Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT07222579
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 a specific type of mixed blood cancer called MPAL (Mixed Phenotype Acute Leukemia), confirmed by laboratory testing according to 2022 medical guidelines.
  • People who have previously had a stem cell transplant from a donor may still be considered, provided it was at least 4 weeks ago, there is no significant transplant-related immune reaction (graft-versus-host disease above a mild level), and immune-suppressing medications have been stopped for at least 1 week (or at least 4 weeks for a specific type called calcineurin inhibitors).
  • People who have leukemia affecting the brain or spinal fluid may still be considered, provided their condition is stable, symptoms have not worsened in the past 4 weeks, and a spinal fluid test taken within the past 2 weeks shows no cancer cells detected by flow cytometry.
  • People who are willing and able to sign a consent form agreeing to take part in the study.
  • People who are able to attend the required clinic or hospital visits and follow the study requirements.
  • People who have abnormal blood test results related to their blood cancer at the time of joining — this is expected and does not prevent participation.

For Cohort A specifically (newly diagnosed patients not suitable for intensive chemotherapy):

  • People aged 75 or older, OR people who have at least one of the following health conditions that make intensive chemotherapy unsuitable: a history of heart failure requiring treatment or a heart pumping function of 50% or less in the past 12 months; a history of stable chest pain (angina); lung function test results below certain thresholds in the past 12 months; a physical performance rating of 3 or 4 on a standard medical scale; or a combined health burden score of 3 or higher on the Charlson Comorbidity Index (confirm with trial site).

For Cohort B specifically (patients in remission but with detectable remaining cancer):

  • People with CD19+ MPAL (a specific type identified by a marker called CD19) who are in remission after at least one round of treatment, but where sensitive testing still detects a small amount of remaining cancer at a level of 0.1% or above.
  • People with a physical performance rating of 2 or lower on a standard medical scale.
  • People whose liver and kidney function tests fall within the ranges required by the trial (confirm specific values with trial site).

For Cohort C specifically (patients whose cancer has returned or not responded to treatment):

  • People with CD19+ MPAL that has come back or has not responded to previous treatment.
  • People who have finished previous chemotherapy at least a set number of days before starting this trial (based on the specific drugs used), and whose side effects from prior chemotherapy have reduced to a mild level or resolved.
  • People with a physical performance rating of 2 or lower on a standard medical scale.
  • People whose liver and kidney function tests fall within the ranges required by the trial (confirm specific values with trial site).

Who may not be able to join:

  • People who are currently receiving another experimental treatment, or who are receiving chemotherapy, radiation therapy, or immunotherapy for their cancer at the same time — although corticosteroids and a drug called hydroxyurea are exceptions and do not disqualify participation.
  • People who have an active infection that is not being treated or is not under control — though people with an infection that is being actively treated and is responding to antimicrobial medication may still be considered.

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 9 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: Ashkan Emadi, MD, WVU Cancer Institute

Phone: 304-293-5949

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
West Virginia University
Registry
ClinicalTrials.gov
Start date
15 January 2026
Est. completion
1 August 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Cohort A - Overall Survival; Cohort B - Rate of Complete Remission (CR), Complete Remission with Partial Hematological Recovery (CRh), or Complete Remission with Incomplete Hematological Recovery (CRi) with Minimal Residual Disease (MRD) negativity; Cohort C - Rate of Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh)

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: 9 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