Ignite Creation Date:
2024-05-06 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03133221
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-23
First Post:
2017-04-13
Brief Title:
1630GCC Zydelig Maintenance in B-Cell Non-Hodgkins Lymphoma After Autologous Stem Cell Transplantation
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
1630GCC A Pilot Study of Zydelig in Patients With B-cell Malignancies as Post-Autologous Transplant Remission Maintenance
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
This is a pilot study to learn how safe and how effective the study drug Zydelig works after autologous stem cell transplant as a maintenance therapy in patients with indolent or transformed indolent B-cell non-Hodgkins lymphoma iNHL or tiNHL
Detailed Description:
This pilot study is focused on maintenance Zydelig for patients with indolent or transformed indolent B-cell non-Hodgkins lymphoma iNHL or tiNHL after autologous stem cell transplantation Oral Zydelig at 150 mg or adjusted dose twice daily continuously on 28-day cycles Patients will continue on Zydelig up to one year or to progressionrelapsedeath or unacceptable toxicity whichever occurs first
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