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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 October 2021 |
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Main ID: |
NCT01553461 |
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Date of registration:
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13/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Transplants With Unlicensed Preserved Cord Blood
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Scientific title:
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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 |
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Date of first enrolment:
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February 21, 2012 |
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Target sample size:
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500 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01553461 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) |
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Address:
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Telephone:
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800-411-1222 |
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Email:
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prpl@cc.nih.gov |
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Affiliation:
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Name:
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Jennifer S Wilder, R.N. |
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Address:
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Telephone:
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(301) 451-3722 |
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Email:
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jw621w@nih.gov |
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Affiliation:
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Name:
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Richard W Childs, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Heart, Lung, and Blood Institute (NHLBI) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
- 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
EXCLUSION CRITERIA:
- 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
Age minimum:
4 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hematologic Neoplasms
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Severe Aplastic Anemia
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Hematologic Diseases
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Myelodysplastic Syndrome (MDS)
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Intervention(s)
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Biological: Cord Blood Transplant
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Primary Outcome(s)
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To examine the incidence of neutrophil recovery of greater than or equal to 500/mm3 after unlicensed CBU transplant.
[Time Frame: 100 days to 1 year]
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Secondary Outcome(s)
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Assess incidence of graft rejection, transmission of infection, serious infusion reactions. Determine 1 year survival. Assess cumulative incidence of acute GVHD (grades II to IV), (grades III to IV), and incidence of chronic GVHD.
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Secondary ID(s)
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12-H-0064
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120064
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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