Actively Recruiting

Phase 2
Age: 0Years - 25Years
All Genders
Healthy Volunteers
NCT06430788

A Study of Emapalumab for Pediatric Aplastic Anemia

Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-12-17

35

Participants Needed

6

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. Funding Source- FDA OOPD

CONDITIONS

Official Title

A Study of Emapalumab for Pediatric Aplastic Anemia

Who Can Participate

Age: 0Years - 25Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing evaluation for suspected newly diagnosed severe aplastic anemia (sAA)
  • Severe cytopenias and a hypocellular marrow concerning for sAA
  • Meet suspected sAA definition (Camitta Criteria): marrow cellularity less than 25%, or 25-50% with less than 30% residual hematopoietic cells
  • Peripheral cytopenias with at least two of the following: ANC less than 500 x 10^9/L, platelets less than 20 x 10^9/L, absolute reticulocyte count less than 60 x 10^9/L
  • No evidence of leukemia or myelodysplastic syndrome (MDS)
  • Younger than 25 years of age at diagnosis
  • Able to tolerate emapalumab and immunosuppressive therapy according to standard institutional organ function criteria
Not Eligible

You will not qualify if you...

  • Uncontrolled infection at presentation
  • Previous treatment for severe aplastic anemia
  • Known inherited bone marrow failure
  • Completed full sAA workup including telomere testing, DEB, genetics when applicable, with an available willing donor and planned hematopoietic stem cell transplant within 2 weeks of enrollment
  • Diagnosis of leukemia or myelodysplastic syndrome
  • Inability of patient or guardian to give informed consent or comply with treatment and research protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

2

Cincinnati Children's Hospital Medical Center (Data collection only)

Cincinnati, Ohio, United States, 45229

Actively Recruiting

3

Children's Hospital of Philadelphia (Data Collection AND Specimen Analysis)

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

4

Virginia Commonwealth University (Data Collection Only )

Richmond, Virginia, United States, 23219

Actively Recruiting

5

Children's Hospital of Wisconsin (Data Collection Only)

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

6

Medical College of Wisconsin (Data Collection AND Data Analysis)

Milwaukee, Wisconsin, United States, 53226

Not Yet Recruiting

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Research Team

A

Andromachi Scaradavou, MD

CONTACT

J

Jaap Jan Boelens, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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