NCT03016806 Umbilical Cord Blood Transplantation From Unrelated Donors
| NCT ID | NCT03016806 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Acute Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2015-06 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2015-06 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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 * Pregnant or breast feeding * Current uncontrolled infection * Evidence of HIV infection or positive HIV serology
Contact & Investigator
Omar Aljitawi, MD
PRINCIPAL INVESTIGATOR
Professor - Department of Medicine, Hematology/Oncology (SMD)
Frequently Asked Questions
Who can join the NCT03016806 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, up to 75 Years, studying Acute Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03016806 currently recruiting?
Yes, NCT03016806 is actively recruiting participants. Contact the research team at omar_aljitawi@urmc.rochester.edu for enrollment information.
Where is the NCT03016806 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT03016806 clinical trial?
NCT03016806 is sponsored by University of Rochester. The principal investigator is Omar Aljitawi, MD at Professor - Department of Medicine, Hematology/Oncology (SMD). The trial plans to enroll 30 participants.
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