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

a study on Hematologic Malignancies Inherited Disorders of Metabolism Inherited Abnormalities of Platelets Histiocytic Disorders Acute Myeloid Leukemia Leukemia Acute Lymphoblastic Leukemia Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases Hodgkin's Lymphoma Lymphoma Non Hodgkin Lymphoma Multiple Myeloma Inherited Abnormalities of Erythrocyte Differentiation or Function Disorders of the Immune System Automimmune Diseases Anemia

Summary

at Oakland, California and other locations
study started

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 Automimmune Diseases Severe Aplastic Anemia Lymphoma Disease Leukemia Multiple Myeloma Neoplasms Lymphoma, Non-Hodgkin Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Leukemia, Myeloid Hodgkin Disease Leukemia, Myelogenous, Chronic, BCR-ABL Positive Congenital Abnormalities Leukemia, Myeloid, Acute Anemia, Aplastic

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

  • Children's Hospital and Research Center of Oakland accepting new patients
    Oakland, California, 94609, United States
  • UCSF (adults) accepting new patients
    San Francisco, California, 94143, United States
  • UCSF (peds) accepting new patients
    San Francisco, California, 94143, United States
  • Stanford University Medical Center accepting new patients
    Stanford, California, 94304, United States
  • UC Davis Cancer Center accepting new patients
    Sacramento, California, 95817, United States
  • Sutter Medical Center accepting new patients
    Sacramento, California, 95816, United States
  • Children's Hospital of Los Angeles accepting new patients
    Glendale, California, 91204, United States
  • UCLA accepting new patients
    Los Angeles, California, 90095, United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, United States
  • City of Hope accepting new patients
    Duarte, California, 91010, United States
  • Children's Hospital of Orange County (CHOC) accepting new patients
    Orange, California, 92868, United States
  • Loma Linda University Cancer Center accepting new patients
    Loma Linda, California, 92350, United States

Details

Status
accepting new patients
Start Date
Sponsor
Center for International Blood and Marrow Transplant Research
ID
NCT01351545
Lead Scientist
Thomas Martin
Study Type
Observational
Last Updated
April 19, 2018
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