Clinical research center conducts clinical trial of Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies

A private, not-for-profit clinical research center City of Hope Medical Center is commencing recruitment for the clinical trial of the Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies.

This phase I trial studies the best dose and side effects of flotetuzumab for the treatment of patients with blood cancers (hematological malignancies) that have spread to other places in the body (advanced) and have come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Flotetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.

A new clinical trial is recruiting patients in the following locations: United States.

The researchers plan that December 30, 2020 will be the study start date. The indicative completion of the clinical trial will be expected in November 15, 2022.

National Cancer Institute (NCI) is the collaborator in this clinical trial.

The inclusion parameters are Tumor expressing CD123 either by flow cytometry or immunohistochemistry staining, Measurable disease of at least 1.5 cm on computed tomography, Life expectancy of at least 4 weeks and others.

There are a number of conditions that do not allow participation, such as:

  • Autologous or allogeneic hematopoietic cell transplant performed within 100 days prior to study drug administration in Day 1 of Cycle 1 of protocol therapy.
  • Chemotherapy, radiation therapy, biological therapy, within 14 days prior to Day 1 of protocol therapy.
  • Previous treatment with immunotherapeutic agents (for example chimeric antigen receptor [CAR] T cells, long acting bispecific antibodies, etc).
  • Use of immunosuppressant medications (other than steroid as noted above) in the 2 weeks prior to study drug administration.
  • Known central nervous system involvement. Patients with suspected CNS involvement must be evaluated by lumbar puncture and be free of CNS disease prior to study entry.

and others.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04681105

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