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Unrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic Anemia

NCT02845596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-11

No results posted yet for this study

Summary

The purpose of this study is to determine the feasibility of comparing outcomes of patients treated de novo with immunosuppressive therapy (IST) versus matched unrelated donor (MUD) hematopoietic stem cell transplant (HSCT) for pediatric acquired severe aplastic anemia.

Conditions

  • Severe Aplastic Anemia

Interventions

DRUG

cyclosporine

cyclosporine

PROCEDURE

Matched Unrelated Donor Hematopoietic Stem Cell Transplant

Matched Unrelated Donor (MUD) Hematopoietic Stem Cell Transplantation (HSCT)

DRUG

horse anti-thymocyte globulin (ATG)

horse anti-thymocyte globulin (ATG)

DRUG

rabbit anti-thymocyte globulin (ATG)

rabbit anti-thymocyte globulin (ATG)

DRUG

methotrexate

methotrexate

DRUG

fludarabine

fludarabine

DRUG

cyclophosphamide

cyclophosphamide

RADIATION

low-dose total body irradiation (TBI)

low-dose total body irradiation (TBI)

PROCEDURE

Immunosuppressive Therapy (IST)

Immunosuppressive Therapy (IST)

Sponsors & Collaborators

  • Michael Pulsipher

    lead OTHER

Principal Investigators

  • Michael Pulsipher, MD · Children's Hospital Los Angeles

  • David A Williams, MD · Boston's Childrens Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2020-11-03
Completion
2023-07-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02845596 on ClinicalTrials.gov