Umbilical Cord Blood Transplantation From Unrelated Donors

NCT03016806 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-10-10

No results posted yet for this study

Summary

This study is being done to determine how long it takes for the engraftment (recovery of blood cell counts) of umbilical cord stem cells and also how often engraftment of umbilical cord stem cells transplanted from an unrelated donor fails. Another purpose will be to document the rate of disease-free survival and the rate of relapse (a return of your disease or syndrome) as well as the incidence and severity of graft versus host disease (GvHD) following cord blood stem cell transplantation. GvHD is a complication of stem cell transplants in which white blood cells from the transplanted tissue (graft) attack the transplant recipient's body (host).

Conditions

Interventions

RADIATION

Total Body Irradiation 1200 cGy

Total Body Irradiation 1200 cGy in 8 fractions

RADIATION

Total Body Irradiation 200 cGy

Total Body Irradiation 200 cGy in one fraction

DRUG

Cyclophosphamide

50 mg/kg or 60 mg/kg

DRUG

Mesna

50 mg/kg or 60 mg/kg plus 10% loading dose

PROCEDURE

Cord Blood Infusion

Intravenous infusion of cord blood stem cells

DRUG

Busulfan

0.8 mg/kg x 16 doses

DRUG

Fludarabine

30 mg/m2/day x 5 or 40 mg/m2/day x 5

DRUG

Melphalan

140 mg/m2

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Omar Aljitawi, MD · Professor - Department of Medicine, Hematology/Oncology (SMD)

Eligibility

Min Age
2 Months
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03016806 on ClinicalTrials.gov