Ignite Creation Date:
2024-05-06 @ 8:09 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02675959
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2016-01-22
Brief Title:
Myeloablative Conditioning Prophylactic Defibrotide and Haplo AlloSCT for Patients With Sickle Cell Disease
Sponsor:
New York Medical College
Organization:
New York Medical College
Study Overview
Official Title:
Safety and Efficacy of Prophylactic Defibrotide in Children Adolescents and Young Adults With Sickle Cell Disease or Beta Thalassemia Following MAC and Haploidentical Stem Cell Transplantation Utilizing CD34 Enrichment and T-Cell CD3 Addback
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NYMC-571
Brief Summary:
This is a follow-up trial to NYMC 526 NCT01461837 to assess the safety efficacy and toxicity of administering Defibrotide prophylaxis for high-risk sickle cell or beta thalassemia patients undergoing a familial haploidentical allogeneic stem cell transplantation with CD34 enrichment and T-cell addback This patient population historically has a risk of developing sinusoidal obstructive syndrome SOS and Defibrotide has demonstrated efficacy in treatment of SOS The Funding Source is FDA OOPD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4090 | OTHER_GRANT | OPD | None |