A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma
|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: NCT02811679|
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : February 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin Lymphoma||Drug: Blinatumomab||Phase 2|
This research study is a Phase II clinical trial. The overall purpose of this study is to determine if blinatumomab is safe and effective for treating adult subjects with relapsed or refractory indolent B cell NHL.
Blinatumomab will be infused causing T cells to recognize the Cancer and work against them. This approach has been FDA approved for acute lymphocytic leukemia but has not yet been approved for lymphoma.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||January 27, 2020|
|Estimated Study Completion Date :||December 2023|
Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
Other Name: Blincyto
- Overall Response Rate [ Time Frame: at completion of treatment (6 months) ]
- Overall Survival Rate [ Time Frame: 2 years ]
- Progression Free Survival Rate [ Time Frame: 2 years ]
- Time To Response Rate [ Time Frame: 2 years ]
- Duration of Response [ Time Frame: 2 years ]
- Rate Patients Are Discontinued From The Drug [ Time Frame: 2 years ]
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): NCT02811679
|United States, Massachusetts|
|Massachusetts general Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jeffrey Barnes, MD, PhD||Massachusetts General Hospital|