A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Lymphoblastic Leukemia (ALL)
- Acute Myelogenous Leukemia (AML or ANLL)
- Autoimmune Diseases
- Other Leukemia
- Chronic Myelogenous Leukemia (CML)
- Disorders of the Immune System
- Hematologic Malignancies
- Non Hodgkin Lymphoma
- Histiocytic Disorders
- Hodgkin Lymphoma
- Inherited Abnormalities of Erythrocyte Differentiation or Function
- Inherited Abnormalities of Platelets
- Inherited Disorders of Metabolism
- Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases
- Other Acute Leukemia
- Severe Aplastic Anemia
- Multiple Myeloma/ Plasma Cell Disorder (PCD)
- Type
- Observational
- Design
- Observational Model: OtherTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
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...
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
Tracking Information
- NCT #
- NCT01351545
- Collaborators
- National Marrow Donor Program
- Investigators
- Study Chair: John Miller, MD, PhD NMDP/CIBMTR