RecruitingNot Applicable

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

United States50 participantsStarted 2020-08-20

Plain-language summary

This is a data collection study that will examine the general diagnostic and treatment data associated with the reduced-intensity chemotherapy-based regimen paired with simple alemtuzumab dosing strata designed to prevented graft failure and to aid in immune reconstitution following hematopoietic stem cell transplantation.

Who can participate

Age range2 Months – 60 Years

SexALL

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Inclusion criteria

✓. Patient, parent, or legal guardian must have given written informed consent.
✓. Patient must be 2 months to 60 years (inclusive) of age at time of consent for all diagnoses.
✓. Patients should have a non-malignant disorder amenable to treatment by stem cell transplantation, including but not limited to the following:
✓. Subjects receive either umbilical cord blood, bone marrow, or peripheral blood stem cell transplant with an alemtuzumab, melphalan, thiotepa, fludarabine and hydroxyurea-based, reduced-intensity conditioning regimen, according to clinical practice at UPMC Children's Hospital of Pittsburgh.

What they're measuring

incidence of acute graft versus host disease (GVHD)

Timeframe: up to 5 years

overall survival after HSCT

Timeframe: up to 5 years

Trial details

NCT IDNCT04528355

SponsorPaul Szabolcs

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Paul Szabolcs, MD

412-692-5427 paul.szabolcs@chp.edu

View on ClinicalTrials.gov More Primary Immunodeficiency (PID) trials