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

Assessing new blood cells growth after transplant using cord blood units that do not meet FDA guidelines but meet NMDP guidelines

a study on Hematologic Malignancies Inherited Disorders of Metabolism Inherited Abnormalities of Platelets Histiocytic Disorders Acute Myeloid Leukemia Leukemia Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia Hodgkin's Lymphoma Lymphoma Non Hodgkin Lymphoma Multiple Myeloma Disorders of the Immune System Autoimmune Disease Anemia

Summary

Location
at Sacramento, California and other locations
Dates
study started
estimated completion

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 Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Hematologic Neoplasms Leukemia, Myeloid, Acute Anemia, Aplastic Congenital Abnormalities Disease 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

  • Sutter Medical Center accepting new patients
    Sacramento California 95816 United States
  • Children's Hospital and Research Center of Oakland accepting new patients
    Oakland California 94609 United States

Details

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