A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma
This study is currently recruiting participants.
Verified February 2017 by Jeffrey Barnes, Massachusetts General Hospital
Information provided by (Responsible Party):
Jeffrey Barnes, Massachusetts General Hospital
First received: June 21, 2016
Last updated: February 27, 2017
Last verified: February 2017
This research study is studying Blinatumomab as a possible treatment for Indolent Non-Hodgkin Lymphoma (NHL).
||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
||A Phase II Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma
Primary Outcome Measures:
- Overall Response Rate [ Time Frame: at completion of treatment (6 months) ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Actual Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2019 (Final data collection date for primary outcome measure)
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
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Participants who have had chemotherapy within 3 weeks, rituximab or obinutuzumab within 4 weeks, or radioimmunotherapy within 6 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier. Subjects actively progressing within that window who have recovered from toxicities of prior therapy are also eligible.
- Autologous stem cell transplantation within 12 weeks prior to study entry
- Prior allogeneic transplant
- Therapeutic doses of corticosteroids within 14 days prior to study entry, defined as >20mg/day pf prednisone, or equivalent. Topical and/or inhaled steroids are permitted.
- Participants who are receiving any other investigational agents.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to blinatumomab
- Subjects with known HIV infection
- Pregnant or lactating subjects.
- Chronic infection with hepatitis B or hepatitis C virus
- History of or current relevant CNS pathology such as epilepsy, seizure, paresis,aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis
- Prior history of another malignancy (except for non-melanoma skin cancer, in situ cervical or breast cancer, or localized prostate cancer) unless disease free for at least one year and felt at low risk of relapse by treating physician.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or uncontrolled systemic fungal, bacterial, viral, or other infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02811679
|Contact: Jeffrey Barnes, MD, PhD
|Massachusetts general Hospital
|Boston, Massachusetts, United States, 02114 |
|Contact: Jeffrey Barnes, MD PhD 617-724-4000 |
|Principal Investigator: Jeffrey Barnes, MD, PhD |
Massachusetts General Hospital
||Jeffrey Barnes, MD, PhD
||Massachusetts General Hospital
||Jeffrey Barnes, MD PhD, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 21, 2016
||February 27, 2017
|Individual Participant Data (IPD) Sharing Statement:
|Plan to Share IPD:
Keywords provided by Jeffrey Barnes, Massachusetts General Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2017
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs