A Phase 2 Study of Isatuximab to Treat Low Blood Cell Counts in People With Blood Cancer Who Had a Stem Cell Transplant from a Donor

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Full Title

Open-Label, Phase II Trial of Isatuximab for Patients with Refractory Immune Cytopenias After Allogeneic Hematopoietic Cell Transplantation

Purpose

Researchers want to see if isatuximab helps improve immune cytopenias (ICs) caused by a donated stem cell transplant. A transplant from a donor is called an allogeneic hematopoietic cell transplant (allo-HCT). People with blood cancers often receive an allo-HCT. ICs are abnormally low blood cell counts that can happen after an allo-HCT. They cause people to need blood or platelet transfusions. Platelets are blood cells needed for clotting. Researchers in this study will see if isatuximab can improve ICs and lessen the need for blood or platelet transfusions.

Isatuximab targets a protein in the body that can cause tumors to grow and also make the immune system overactive. Isatuximab may help protect healthy cells from damage. It is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have low blood cell counts after having allo-HCT.
  • Have had your transplant at least 45 days before getting isatuximab.
  • Have blood cell counts that are low even with standard treatment for ICs.
  • Be in remission from the blood cancer for which you had an allo-HCT.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Michael Scordo’s office at 646-608-3771.

Protocol

23-119

Phase

Phase II (phase 2)

Investigator

ClinicalTrials.gov ID

NCT05873205