Ignite Creation Date:
2024-05-06 @ 1:42 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01874288
Status:
TERMINATED
Last Update Posted:
2020-11-24
First Post:
2013-06-07
Brief Title:
A Study of De-immunized DI-Leu16-IL2 Administered Subcutaneously in Participants With B-cell NHL
Sponsor:
Alopexx Oncology LLC
Organization:
Alopexx Oncology LLC
Study Overview
Official Title:
A Phase III Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered Subcutaneously in Patients With B-cell Non-Hodgkin Lymphoma NHL
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Clinical benefit was noted in the earlier portion of the trial hence participants were not enrolled in 2 expansion cohorts and the study was terminated early
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DI-Leu16-IL2
Brief Summary:
This dose-escalation study is designed for determining the safety tolerability pharmacokinetics PK biological and clinical activity of DI-Leu16-IL2 administered to participants with cluster of differentiation 20 CD20 positive NHL that have failed standard rituximab-containing therapy
Detailed Description:
The participants will be enrolled during dose escalation and during 2 expansion cohorts of up to 12 participants each
The dose escalation portion of the trial will incorporate a modified accelerated titration design Therefore the trial will enroll 3 participants per dose level with a doubling of the dose at each level during the accelerated stage of the study skipping every other dose level Once the first instance of any Grade 3 or higher treatment related toxicity with some notable exceptions is observed on the first cycle the accelerated stage will end and the trial will revert to a conventional design using cohorts of 3 or 6 participants standard 33 design with single step 2 milligrams mgsquare meter m2 increments
To further explore the clinical efficacy additional participants up to 12 per cohort may be enrolled at the optimal biologic dose OBD or maximum tolerated dose MTD
At the end of the study participants may be enrolled into an open-label extension study AO-101-EXT NCT02151903 at the discretion of the investigator
The dose escalation portion of the trial will incorporate a modified accelerated titration design Therefore the trial will enroll 3 participants per dose level with a doubling of the dose at each level during the accelerated stage of the study skipping every other dose level Once the first instance of any Grade 3 or higher treatment related toxicity with some notable exceptions is observed on the first cycle the accelerated stage will end and the trial will revert to a conventional design using cohorts of 3 or 6 participants standard 33 design with single step 2 milligrams mgsquare meter m2 increments
To further explore the clinical efficacy additional participants up to 12 per cohort may be enrolled at the optimal biologic dose OBD or maximum tolerated dose MTD
At the end of the study participants may be enrolled into an open-label extension study AO-101-EXT NCT02151903 at the discretion of the investigator
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