Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517530
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2007-08-16
Brief Title:
A Dose-Escalating Study of Obinutuzumab in Patients With B-lymphocyte Antigen CD20 Malignant Disease GAUGUIN
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-label Multicentre Nonrandomized Dose-escalating Phase III Study With a Randomized Phase II Part to Investigate the Safety and Tolerability of RO5072759 Given as Monotherapy in Patients With CD20 Malignant Disease
Status:
COMPLETED
Status Verified Date:
2016-08
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:
The primary objective for the phase I part of the study is to investigate the safety and tolerability of escalating intravenous IV doses of obinutuzumab given as monotherapy in participants with CD20 tumor-infiltrating lymphocytic Malignant Disease including B-cell chronic lymphocytic leukemia CLL and Non-Hodgkins Lymphoma NHL The primary objective for the phase II part of the study is to investigate the efficacy and safety of one dose of obinutuzumab in participants with relapsedrefractory CLL and NHL that is in turn either indolent iNHL or aggressive aNHL
It is an open label dose escalating study in phase I and open label in phase II but the two doses in iNHL aNHL are randomized to high or low dose of the same open label treatment CLL was not randomized as only one dose level was used
Participants with a response who might gain additional benefit from being treated again in the opinion of the investigator may be enrolled in a Retreatment Period
It is an open label dose escalating study in phase I and open label in phase II but the two doses in iNHL aNHL are randomized to high or low dose of the same open label treatment CLL was not randomized as only one dose level was used
Participants with a response who might gain additional benefit from being treated again in the opinion of the investigator may be enrolled in a Retreatment Period
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-001103-37 | EUDRACT_NUMBER | None | None |