Umbilical Cord Blood Transplantation From Unrelated Donors

  • STATUS
    Recruiting
  • End date
    Jun 15, 2026
  • participants needed
    30
  • sponsor
    University of Rochester
Updated on 16 May 2021
remission
chronic myeloid leukemia
stem cell transplantation
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
blast crisis
anemia
cyclophosphamide
immunodeficiency
lymphoma
busulfan
multiple myeloma
hodgkin's disease
umbilical cord blood transplantation
melphalan
cell transplantation
leukemia
lymphocytic leukemia
gilbert's syndrome
shortening fraction
induction therapy
hemolysis
white blood cells
chemotherapy regimen
wbc count
follicular lymphoma
treatment-related aml
mesna
solid tumour
aplastic anemia
severe aplastic anemia
primary disease
wiskott-aldrich syndrome
refractory multiple myeloma
fab m6
severe combined immunodeficiency

Summary

This study is a single-center, treatment protocol with 4 possible preparative regimens, designed to validate the process of umbilical cord blood stem cell transplantation at our institution.

Description

This study is a single-center treatment protocol with four possible preparative regimens, designed to validate the process of umbilical cord blood stem cell transplantation at our institution. Enrolled patients will receive chemotherapy +/-total body radiation as a pre-transplant conditioning regimen. Patients will then receive cord blood stem cells followed by GvHD prophylaxis that will include Tacrolimus and Mycophenolate Mofetil, or Cyclosporin A and Methylprednisolone. Multiple data points will be collected prior to, during, and following transplantation to ensure safety of the process and to evaluate the stated objectives.

Details
Condition Metabolic disorder, Bone marrow disorder, Multiple Myeloma, Immunodeficiency, Lymphoma, Preleukemia, Anemia, Aplastic Anemia, Lymphoproliferative Disorder, Lymphoma, MYELODYSPLASTIC SYNDROME, Non-Hodgkin's Lymphoma, Myelodysplastic Syndromes (MDS), Solid Tumors, Solid Tumor, Acute Leukemia, Solid Neoplasm, Congenital Hematological Disorder, Chronic Leukemia, Solid Tumour, Immune Deficiency, Anemia; Non-Small-Cell Lung Cancer, Primary Immunodeficiency Disorders, Anemia; Non-Hodgkin’s Lymphoma, Metabolic Disorders, Lymphoproliferative disorders, myelodysplastic syndromes, immunodeficient, immunodeficiencies, decreased immune function, lymphomas, multiple myeloma (mm), myelodysplastic syndrome (mds), metabolic diseases, metabolic disease, metabolism disorders, leukemia, chronic, chronic leukemias, acute leukemias
Treatment cyclophosphamide, busulfan, melphalan, Fludarabine, MESNA, Cord Blood Infusion, Total Body Irradiation 1200 cGy, Total Body Irradiation 200 cGy
Clinical Study IdentifierNCT03016806
SponsorUniversity of Rochester
Last Modified on16 May 2021

Eligibility

Yes No Not Sure

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
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