A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01351545|
Recruitment Status : Recruiting
First Posted : May 11, 2011
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment|
|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||Drug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)|
The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers.
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.
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.
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 Type :||Observational|
|Estimated Enrollment :||99999 participants|
|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|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2021|
The cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.
Drug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351545
|Contact: Kelsey Schertz, MPHemail@example.com|
|Contact: Danielle Rusnak||763-406-3400||drusnak@NMDP.ORG|
|Study Chair:||John Miller, MD, PhD||NMDP/CIBMTR|