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

Hodgkin Lymphoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myelogenous Leukemia (AML or ANLL)
  • Anemia, Aplastic
  • Autoimmune Diseases
  • Chronic Myelogenous Leukemia (CML)
  • Congenital Abnormalities
  • Disorders of the Immune System
  • Hematologic Malignancies
  • Hematologic Neoplasms
  • Histiocytic Disorders
  • Hodgkin Lymphoma
  • Inherited Abnormalities of Erythrocyte Differentiation or Function
  • Inherited Abnormalities of Platelets
  • Inherited Disorders of Metabolism
  • Leukemia
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Lymphoma
  • Multiple Myeloma
  • Multiple Myeloma/ Plasma Cell Disorder (PCD)
  • Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases
  • Neoplasms
  • Non-hodgkin Lymphoma
  • Other Acute Leukemia
  • Other Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Severe Aplastic Anemia
Clinical Trial Details
NCT number NCT01351545
Study type Observational
Source Center for International Blood and Marrow Transplant Research
Contact Shannon Clark, MS
Email 10-CBA@ndmp.org
Status Recruiting
Phase
Start date October 2011
Completion date October 2041
View Details
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