1. Investigational drugs: Anti-CD47 monoclonal antibody, Hu5F9-G4 (target therapy that blocks the growth of cancer cells)
  2. For what level of MDS severity risk:
  3. What subtype of MDS: Patients with Acute Myeloid Leukemia that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory).
  4. Aims and benefits: This is a safety study. It aims to determine the side effects and the maximum tolerated dose of the drug.
  5. Basic inclusion criteria:
    • Confirmed relapsed or refractory (primary refractory and relapsed refractory) AML for which no further conventional therapy is suitable for the patient within 3 weeks of registration
    • Peripheral white blood cell (WBC) count =10x109/L within 1 week of registration
    • ECOG performance score of 0 or 1
    • Willing to undergo blood transfusions as deemed clinically necessary.
  6. Basic exclusion criteria:
    • Pregnant or breastfeeding women.
    • Any prior exposure to Hu5F9-G4 or other CD47 targeting agents.
    • Treatment with any other investigational agent within 28 days prior to enrolment.
    • Prior cytotoxic chemotherapy (with the exception of hydroxycarbamide), immunotherapy, or radiotherapy within 4 weeks
    • Patients with known inherited or acquired bleeding disorders.
    • Previous allogeneic stem cell transplant.
    • Evidence for active CNS involvement by leukaemia.
    • Any other malignancy within the previous 24 months, with the exception of adequately treated conebiopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
  7. Trial sites/locations and name of physician in charge of trial: University Hospital of Wales, Cardiff; St. James University Hospital, Leeds; The Royal Liverpool University Hospital, Liverpool; The Christie NHS Foundation Trust, Manchester; Churchill Hospital, Oxford.
  8. More information:

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