Ignite Creation Date:
2024-05-06 @ 12:17 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01535989
Status:
COMPLETED
Last Update Posted:
2016-06-07
First Post:
2012-01-27
Brief Title:
Study of Inotuzumab Ozogamicin Temsirolimus in Patients With Relapsed or Refractory CD22 B-cell NHLymphoma
Sponsor:
Cristiana Sessa
Organization:
Oncology Institute of Southern Switzerland
Study Overview
Official Title:
A Phase I Study of Inotuzumab Ozogamicin CMC-544 in Combination With Temsirolimus CCI-779 in Patients With Relapsed or Refractory CD22-positive B-cell Non Hodgkins Lymphomas
Status:
COMPLETED
Status Verified Date:
2016-06
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:
IOSI-LND-001
Brief Summary:
This is an open label phase I study of Inotuzumab Ozogamicin an antibody-targeted intravenous chemotherapy agent composed of a CD22-targeted antibody linked to calicheamicin in combination with the mammalian target of rapamycin mTOR inhibitor Temsirolimus in patients with relapsedrefractory CD22 B-cell non Hodgkins lymphomas NHLs Both Inotuzumab Ozogamicin and Temsirolimus have been evaluated as single agents as well as in combination with rituximab in patients with NHLs This is the first study combining the two agents together In the present study Inotuzumab Ozogamicin will be administered intravenously on d1 at the starting dose of 08 m2 Temsirolimus will be administered intravenously on days 1815 and 22 at the starting dose of 15mg Cycles will be repeated every 28 days
Detailed Description:
None
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