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Actively Recruiting

Age: 2Months - 60Years
All Genders
ID04528355

Outcomes Study of Children and Adults With Non-Malignant Disorders Undergoing Stem Cell Transplants Using Reduced-Intensity Chemotherapy and Alemtuzumab

Led by Paul Szabolcs · Updated on 2026-01-13

50

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting clinical data from patients with various non-malignant disorders undergoing hematopoietic stem cell transplantation HSCT using a reduced-intensity chemotherapy-based regimen. This regimen includes alemtuzumab and other drugs and aims to reduce graft failure and help immune system recovery. The study follows patients with conditions like primary immunodeficiency, inherited metabolic disorders, hereditary anemias, and inflammatory diseases to better understand treatment outcomes. Participants will receive one of three types of stem cell transplants umbilical cord blood, bone marrow, or peripheral blood stem cells. All receive a reduced-intensity conditioning regimen that involves alemtuzumab, melphalan, thiotepa, fludarabine, and hydroxyurea, administered according to the treating physicians guidance at the UPMC Childrens Hospital of Pittsburgh. This observational study gathers medical data without altering standard care. During the study, researchers will monitor outcomes such as the occurrence of acute graft versus host disease GVHD and overall survival for up to five years after transplantation. They will also assess engraftment levels, the timing of immune system recovery, the use of immunosuppressant medications, and donor leukocyte infusions. Medical information will be collected from patients charts after informed consent, with follow-up extending up to five years to evaluate long-term results.

CONDITIONS

Brief Title

Data Collection Study of Patients With Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT With RIC

Who Can Participate

Age: 2Months - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient, parent, or legal guardian has provided written informed consent
  • Patient is between 2 months and 60 years old at time of consent
  • Patient has a non-malignant disorder suitable for stem cell transplantation, including primary immunodeficiency syndromes, congenital bone marrow failure syndromes, inherited metabolic disorders, hereditary anemias, or inflammatory conditions
  • Patient will receive umbilical cord blood, bone marrow, or peripheral blood stem cell transplant with a reduced-intensity conditioning regimen including alemtuzumab, melphalan, thiotepa, fludarabine, and hydroxyurea
Not Eligible

You will not qualify if you...

Research Team

P

Paul Szabolcs, MD

S

Shawna McIntyre, RN

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