Transplanting umbilical cord blood from unrelated donors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center treatment protocol that evaluates umbilical cord blood stem cell transplantation using four different preparative regimens. Patients will undergo chemotherapy with or without total body radiation as a pre-transplant conditioning regimen. Following this, they will receive cord blood stem cells along with graft-versus-host disease prophylaxis. The study aims to collect multiple data points to ensure the safety of the procedure and assess its effectiveness.

Why it matters

Who can join: the full rules

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

Where it's running

• Wilmot Cancer Institute
  Rochester, New York, United States Recruiting

Study contacts

• Principal investigator: Omar Aljitawi, MD — Professor - Department of Medicine, Hematology/Oncology (SMD)
• Study coordinator: Omar Aljitawi, MD
• Email: omar_aljitawi@urmc.rochester.edu
• Phone: 585-275-4099

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.