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A Study of Emapalumab for Pediatric Aplastic Anemia

A Study of Emapalumab for Pediatric Aplastic Anemia

Recruiting
25 years and younger
All
Phase 2

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Overview

The purpose of this study is to find out whether upfront emapalumab treatment can help in sAA (Aplastic Anemia) treatment planning and increase the effectiveness of standard treatment options.

Eligibility

Inclusion Criteria:

  • Patients undergoing workup for suspected newly diagnosed sAA:
    • Patients with severe cytopenias and a hypocellular marrow concerning for sAA
    • Patients that meet the definition for suspected sAA (Camitta Criteria) as
      follows

Marrow Cellularity: <25%, or 25-50% with <30% residual hematopoietic cells Peripheral cytopenias (at least 2 of 3) Absolute neutrophil count (ANC): <500 x 10^9/L Platelets: <20 x 10^9/L Absolute Reticulocyte Count: <60 x 10^9/L

  • Patients that do not have evidence of leukemia or MDS
  • Patients < 25 years of age at time of diagnosis
  • Able to tolerate emapalumab and IST (with standard institutional organ function criteria)

Exclusion Criteria:

  • Uncontrolled infection at presentation.
  • Patients who have undergone previous treatment for sAA.
  • Patients with known inherited bone marrow failure
  • Patient who has completed a full workup for sAA including having results back from telomere testing, DEB and genetics (when applicable), as well as having an appropriate willing and available donor and would otherwise be admitted for HSCT within 2 weeks of enrolling on the trial
  • Patients with leukemia or MDS
  • Patient or parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests.

Study details
    Aplastic Anemia
    Cytopenia
    Hypocellular Marrow

NCT06430788

Memorial Sloan Kettering Cancer Center

29 April 2025

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