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

a study on Hematologic MalignanciesInherited Disorders of MetabolismInherited Abnormalities of PlateletsHistiocytic DisordersAcute Myeloid LeukemiaLeukemiaAcute Lymphoblastic LeukemiaHodgkin's LymphomaLymphomaNon Hodgkin LymphomaMultiple MyelomaDisorders of the Immune SystemAutomimmune DiseasesAnemia

Summary

at Oakland, California and other locations
study started
Thomas Martin

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 MalignanciesInherited Disorders of MetabolismInherited Abnormalities of PlateletsHistiocytic DisordersAcute Myelogenous Leukemia (AML or ANLL)Acute Lymphoblastic Leukemia (ALL)Other Acute LeukemiaChronic Myelogenous Leukemia (CML)Myelodysplastic (MDS) / Myeloproliferative (MPN) DiseasesOther LeukemiaHodgkin LymphomaNon-hodgkin LymphomaMultiple Myeloma/ Plasma Cell Disorder (PCD)Inherited Abnormalities of Erythrocyte Differentiation or FunctionDisorders of the Immune SystemAutomimmune DiseasesSevere Aplastic AnemiaLymphomaDiseaseLeukemiaMultiple MyelomaNeoplasmsLymphoma, Non-HodgkinPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemia, MyeloidHodgkin DiseaseLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCongenital AbnormalitiesLeukemia, Myeloid, AcuteAnemia, AplasticA multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)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

  • Children's Hospital and Research Center of Oaklandaccepting new patients
    OaklandCalifornia94609United States
  • UCSF (adults)accepting new patients
    San FranciscoCalifornia94143United States
  • UCSF (peds)accepting new patients
    San FranciscoCalifornia94143United States

Lead Scientist

  • Thomas Martin
    Authored (or co-authored) 34 research publications

Details

Status
accepting new patients
Start Date
Sponsor
Center for International Blood and Marrow Transplant Research
ID
NCT01351545
Study Type
Observational
Last Updated