Studies cord blood stem cell transplants from unrelated donors in people with blood disorders
Follows people with leukemia or other blood disorders after cord blood stem cell transplant.
Plain-language title generated from the registry record
Registry title: Umbilical Cord Blood Transplantation From Unrelated Donors
Key facts
- Where
- Rochester, United StatesSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 2 months to 75 years who have a blood disease, cancer, immune disorder or metabolic disorder that a stem cell transplant can treat. They receive umbilical cord blood stem cells from an unrelated donor.
- Age
- From 2 Months to 75 Years
- Sex
- All sexes can join.
- Disease stage
- Diseases that a stem cell transplant can treat: immune deficiencies, inherited blood or metabolic disorders, severe aplastic anemia, high-risk leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, or some solid tumors. Leukemia and lymphoma must be hard to treat or have come back.
- Earlier treatment
- Some groups need earlier treatment first, such as lymphoma that came back or got worse after earlier treatments, or myeloma that came back after high-dose therapy and an autologous stem cell transplant. An autologous transplant less than 6 months before cannot be counted.
- Biomarker or test result
- Some leukemia types are named by features such as FLT3 abnormalities or adverse cytogenetics. Heart, lung, kidney and liver tests must be in the ranges set by the trial, with a performance score of 70% or more.
Main reasons for not taking part
- A fully or nearly fully tissue-compatible related or unrelated donor is available in time
- Autologous stem cell transplant less than 6 months ago
- Pregnant or breastfeeding
- Current infection that is not controlled
- HIV infection or positive HIV test
Read by machine on 12 November 2026.
Where in United States
- Wilmot Cancer InstituteRochester, United StatesContact: Omar Aljitawi, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Rochester
- Trial code
- NCT03016806
- Record updated
- 10 October 2025
- Original description
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).Read full original descriptionShow less
Umbilical Cord Blood Transplantation From Unrelated Donors
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).
Inclusion: Appropriate diagnosis: Patients must have a disease or syndrome amenable to therapy with hematopoietic stem cell transplantation. Diagnoses include, but are not limited to:; Congenital and Other Non-malignant Disorders:; Immunodeficiency disorders (e.g. Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome); Congenital hematopoietic stem cell defects (e.g. Chediak-Higashi Syndrome, Congenital Osteopetrosis, Osteogenesis Imperfecta); Metabolic disorders (e.g. Hurler's Syndrome); Severe aplastic anemia; High-Risk Leukemia:; Acute Myelogenous Leukemia; Refractory to standard induction therapy (more than 1 cycle required to achieve remission); Recurrent (in CR ≥ 2); Treatment-related AML or MDS; Evolved from myelodysplastic syndrome; Presence of FLT3 abnormalities; FAB M6 or M7; Adverse cytogenetics; Myelodysplastic Syndrome; Acute Lymphoblastic Leukemia including T lymphoblastic leukemia:; Refractory to standard induction therapy (time to CR >4 weeks); Recurrent (in CR ≥ 2); WBC count >30,000/mcL at diagnosis; Age >30 at diagnosis; Adverse cytogenetics, such as t(9:22), t(1:19), t(4:11), and other MLL rearrangements; Chronic Myelogenous Leukemia in accelerated phase or blast crisis; Biphenotypic or undifferentiated leukemia; Burkitt's leukemia or lymphoma; Lymphoma:; Large cell, Mantle cell, Hodgkin lymphoma refractory or recurrent, chemo-sensitive, and ineligible for an autologous stem cell transplant or previously treated with autologous SCT; Marginal zone or follicular lymphoma that is progressive after at least two prior therapies; Multiple Myeloma, recurrent following high-dose therapy and autologous SCT or ineligible for an autologous HSCT; Solid tumors, with efficacy of allogeneic HSCT demonstrated for the specific disease and disease status; Adequate organ function:; Cardiac - LVEF >45%, or shortening fraction >25%, Absence of congestive heart failure or conduction disturbances with high risk for sudden death; Pulmonary - DLCO (corrected for hemoglobin), FEV1 and FVC ≥ 50% predicted; Renal - serum Cr < 1.5 times the upper limit of normal for age or GFR ≥ 50 ml/min/1.73m2; Hepatic - total bilirubin level < 2 times the upper limit of normal (except for patients with Gilbert's syndrome or hemolysis); if the primary disease process is causal, this criterion will be reconsidered. ALT, AST, and Alkaline phosphatase ≤ 5 times upper limit of normal; Performance Status Karnofsky or Lansky score ≥ 70%; Informed Consent must be obtained prior to initiating conditioning therapy; Receipt of viable cord blood product(s), single or dual, must be confirmed with the stem cell processing laboratory prior to initiating conditioning therapy.
Exclusion: Availability of 10/10 or 9/10 HLA-matched related or unrelated donor within a reasonable timeframe dictated by the clinical urgency of the transplant; Autologous HSCT < 6 months prior to proposed UCB transplant; Current uncontrolled infection; Evidence of HIV infection or positive HIV serology; Pregnant or breast feeding.