Viewing Study NCT03600909



Ignite Creation Date: 2024-05-06 @ 11:49 AM
Last Modification Date: 2024-10-26 @ 12:50 PM
Study NCT ID: NCT03600909
Status: TERMINATED
Last Update Posted: 2022-04-12
First Post: 2018-07-17

Brief Title: A Study of the Effect of Blood Stem Cell Transplant After Chemotherapy Alone in Patients With Fanconi Anemia
Sponsor: Memorial Sloan Kettering Cancer Center
Organization: Memorial Sloan Kettering Cancer Center

Study Overview

Official Title: A Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor Using a Risk-Adjusted Chemotherapy Only Cytoreduction With Busulfan Cyclophosphamide and Fludarabine
Status: TERMINATED
Status Verified Date: 2021-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Accrual has been slow
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this study is to see if the study therapy can decrease the chemotherapy-related side effects while maximizing the effectiveness of disease control The physicians will also be studying the effect of removing T-cells from the donors stem cells before transplant T-cells are a type of white blood cell that may help cause a serious side effect of transplant called Graft versus Host Disease GVHD The way it removes the T-cells from the donor stem cells is actually by selecting only the stem cells called CD34 cells by using a device called CliniMACS This process is called CD34 selection The CliniMACS device is currently under the supervision of the FDA
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None