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Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase II
Eligibility
0 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT01656603
Protocol IDs
6637-01 (primary)
NCI-2016-01676
Study Sponsor
New York Blood Center

Summary

This study will evaluate the safety of infusion of the investigational cord blood units by
carefully documenting all infusion-related problems.

Objectives

The primary aim of this study is to examine the safety of administration of the unlicensed
investigational NCBP hematopoietic progenitor cell-cord blood (HPC-CORD BLOOD) products in a
multi-institution setting. Therefore, the study will evaluate prospectively the incidence of
serious adverse reactions as well as the incidence of all infusion related reactions after
administration of the unlicensed, investigational NCBP CBU.

Definitions of Infusion-related adverse reactions:

Mild - Moderate: reactions during or after the infusion of the cord blood (CB) product that
require some medical intervention but do not affect the overall patient status or outcome.

Severe: serious, life-threatening or fatal infusion reactions, requiring major medical
intervention. These include: anaphylactic shock, acute cardiac, pulmonary or renal failure,
seizures, patient transfer to the Intensive Care Unit, or death within 48 hours of the CB
infusion. Adverse Reactions will also be classified by grade, according to the Common
Terminology Criteria for Adverse Events v4.0 (CTCAE).

Eligibility

  1. Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
  2. Patients: Patients of any age and either gender
  3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)

Treatment Sites in Georgia

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

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