Ignite Creation Date:
2024-05-05 @ 9:53 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00989586
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2009-10-02
Brief Title:
Veltuzumab and Milatuzumab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Sponsor:
Beth Christian
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase III Study of Veltuzumab IMMU-106 hA20 a Humanized Anti-CD20 Monoclonal Antibody Combined With Milatuzumab IMMU-115 hLL1 a Humanized Anti-CD74 Monoclonal Antibody in Relapsed and Refractory B-cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-12
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:
A phase I dose escalation study of veltuzumab and milatuzumab in relapsed and refractory B-cell NHL The phase I study will be followed by a pilot phase II study
Detailed Description:
A phase III study of veltuzumab combined with milatuzumab in relapsed and refractory non-Hodgkins lymphoma Both agents are well-tolerated in early phase clinical testing with infusion reactions as the primary observed toxicity Preclinical testing in vitro and in vivo have demonstrated single agent activity for both veltuzumab and milatuzumab In mantle cell lymphoma cell lines and SCID mouse models synergist effects were observed when milatuzumab was combined with rituximab Veltuzumab has several advantages over rituximab including slower off-rates shorter infusion times higher potency and improved therapeutic responses in animal models Previous and ongoing clinical investigations support the concept of combining monoclonal antibodies in NHL
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-03150 | REGISTRY | Clinical Trial Reporting Program | None |