Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569082
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
CD34 Selected Stem Cell for Poor Graft Function or Graft Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CD34 Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed trial is a single arm non-randomized single center pilot study utilizing CliniMACS CD34 Reagent System for patients following allogeneic hematopoietic stem cell transplant HSCT requiring treatment of graft dysfunction or failure
Detailed Description:
The primary objective of the study is to estimate the incidence of engraftment with sustained recovery of blood counts including absolute neutrophil cell ANC and platelet engraftment
ANC engraftment is defined as ANC of 05 109L for three consecutive laboratory values obtained on different days Date of ANC recovery is the date of the first of three consecutive laboratory values where the ANC is 05 109L
Platelet engraftment should reflect no platelet transfusions administered for seven consecutive days Report the date of the first of three consecutive laboratory values 20 109L obtained on different days
The secondary objective of the study is to estimate the incidence of Graft-versus-host disease GvHD and side effects that can be attributed to the CliniMACS CD34 Selected Cellular Product
ANC engraftment is defined as ANC of 05 109L for three consecutive laboratory values obtained on different days Date of ANC recovery is the date of the first of three consecutive laboratory values where the ANC is 05 109L
Platelet engraftment should reflect no platelet transfusions administered for seven consecutive days Report the date of the first of three consecutive laboratory values 20 109L obtained on different days
The secondary objective of the study is to estimate the incidence of Graft-versus-host disease GvHD and side effects that can be attributed to the CliniMACS CD34 Selected Cellular Product
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None