Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Patients With B-cell NHL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02151903|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|B-cell Non-Hodgkin Lymphoma||Drug: DI-Leu16-IL2||Phase 1 Phase 2|
• To continue to provide DI-Leu16-IL2 to patients currently enrolled in Alopexx Oncology trial AO-101 who are experiencing clinical benefit.
- To continue to evaluate the safety of DI-Leu16-IL2.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Patients With B-cell Non-Hodgkin Lymphoma (NHL)|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Patients will receive DI-Leu16-IL2 at the same assigned dose level, dosing schedule, and route of administration that they received during the parent clinical trial AO-101. Patients may continue to receive therapy through the duration of the study as long as they are having clinical benefit and not experiencing any untoward side effects.
- Tumor response in patients [ Time Frame: up to 12 months ]Tumor measurements will be performed by radiologic imaging techniques at every other monthly visit. The International Workshop for NHL Response Criteria will be used to evaluate the response.
- Safety assessment in patients monitoring adverse events [ Time Frame: up to 12 months ]
- Safety assessment in patients monitoring clinical laboratory tests [ Time Frame: up to 12 months ]
- Safety assessment in patients monitoring physical exams [ Time Frame: up to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151903
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Study Director:||Daniel Vlock, MD||Alopexx Oncology, LLC|