Umbilical Cord Blood Transplantation From Unrelated Donors
NCT03016806 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2025-10-10
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
- Acute Leukemia
- Immune Deficiency Disorder
- Congenital Hematological Disorder
- Metabolism Disorder
- Aplastic Anemia
- Myelodysplastic Syndromes
- Chronic Leukemia
- Lymphoma
- Multiple Myeloma
- Solid Tumor
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
-
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
-
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
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