RECRUITING

Umbilical Cord Blood Transplantation From Unrelated Donors

Conditions

Acute Leukemia Immune Deficiency Disorder Congenital Hematological Disorder Metabolism Disorder Aplastic Anemia Myelodysplastic Syndromes Chronic Leukemia Lymphoma Multiple Myeloma Solid Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Umbilical Cord Blood Transplantation From Unrelated Donors

Quick Facts

Study Start:2015-06

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03016806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Months to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Omar Aljitawi, MD

CONTACT

585-275-4099

omar_aljitawi@urmc.rochester.edu

Principal Investigator

Omar Aljitawi, MD

PRINCIPAL_INVESTIGATOR

Professor - Department of Medicine, Hematology/Oncology (SMD)

Study Locations (Sites)

Wilmot Cancer Institute

Rochester, New York, 14642

United States

Collaborators and Investigators

Sponsor: University of Rochester

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-06

Study Completion Date2027-06

Study Record Updates

Study Start Date2015-06

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Acute Leukemia
Immune Deficiency Disorder
Congenital Hematological Disorder
Metabolism Disorder
Aplastic Anemia
Myelodysplastic Syndromes
Chronic Leukemia
Lymphoma
Multiple Myeloma
Solid Tumor