Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-01 @ 12:07 PM
Study NCT ID:
NCT00896493
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2009-05-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
A Phase II Study of Non-myeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) In Patients With Cutaneous T Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-05
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:
None
Brief Summary:
Non-myeloablative approach for allogeneic transplant is a reasonable option, especially given that the median age at diagnosis is 55-60 years and frequently present compromised skin in these patients, which increases the risk of infection. Therefore, we propose a clinical study with allogeneic hematopoietic stem cell transplantation (HSCT) using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary syndrome (MF/SS).
Detailed Description:
Primary Objectives
-To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival.
Secondary Objectives
-To evaluate the incidence and extent of acute and chronic graft-versus-host disease (GVHD) and time to engraftment.
-To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival.
Secondary Objectives
-To evaluate the incidence and extent of acute and chronic graft-versus-host disease (GVHD) and time to engraftment.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: