A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

a study on Hematologic Malignancy Disorders of Metabolism Abnormalities of Platelets Histiocytic Disorders Acute Myeloid Leukemia Leukemia Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia Hodgkin's Lymphoma Lymphoma Non-Hodgkin Lymphoma Multiple Myeloma Abnormalities of Erythrocyte Differentiation or Function Autoimmune Disease Anemia Neoplasms Hematologic Neoplasms

Summary

Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

Summary

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Official Title

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients with Hematologic Malignancies and Other Indications

Details

Principal Investigators:

The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers.

Study Design:

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Primary Objective:

The primary objective of this study is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.

Secondary Objectives:

In patients receiving a non-licensed CBU:

  • Assess incidence of transmission of infection
  • Assess incidence of serious infusion reaction
  • Determine 1 year overall survival after cord blood transplantation
  • Assess cumulative incidence of acute graft vs. host disease (GVHD) grades II to IV and grades III to IV
  • Assess cumulative incidence of chronic GVHD
  • Determine platelet engraftment of >20,000 mcL and >50,000 mcL

Keywords

Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Acute Myelogenous Leukemia (AML or ANLL), Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Other Leukemia, Hodgkin Lymphoma, Non-hodgkin Lymphoma, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Autoimmune Diseases, Severe Aplastic Anemia, Lymphoma, Leukemia, Multiple Myeloma, Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myeloid Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hematologic Neoplasms, Leukemia, Myeloid, Acute, Aplastic Anemia, Congenital Abnormalities, Unlicensed CBU

Eligibility

You can join if…

  • Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
  • Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
  • Pediatric and adult patients of any age

You CAN'T join if...

  • Patients who are receiving only licensed CBUs
  • Cord blood transplant recipients at international transplant centers
  • Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
  • Patients whose selected unlicensed CBU(s) will be more than minimally manipulated

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • Scripps Green Hospital accepting new patients
    LaJolla California 92037 United States
  • Rady Children's Hospital San Diego accepting new patients
    San Diego California 92123 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Center for International Blood and Marrow Transplant Research
ID
NCT01351545
Study Type
Observational
Participants
Expecting 99999 study participants
Last Updated
Contact us about this trial