Non-Hodgkin LymphomaPhase 2NCT02811679
A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma
A Phase 2 study testing Blinatumomab in people with Non-Hodgkin Lymphoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is studying Blinatumomab as a possible treatment for Indolent Non-Hodgkin Lymphoma (NHL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have histologically determined B cell NHL that is relapsed or primary refractory after initial therapy.
- Follicular Lymphoma of any grade
- Marginal zone lymphoma (extranodal, nodal, or splenic). Patients with gastric MALT must have progressed after H. Pylori therapy and radiation. Patients with splenic MZL must have prior splenectomy.
- At least 1 prior line of chemoimmunotherapy if primary refractory or relapsed with in one year. Subjects who respond to initial therapy for greater than one year must have had at least 2 prior lines of therapy including one line with chemoimmunotherapy including an anti-CD20 monoclonal antibody
- Measurable disease that has not been previously irradiated on PET-CT of at least 1.5cm,
- Age ≥18 years.
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- ECOG performance status ≤2 ( see Appendix A)
- Participants must have adequate organ and marrow function as defined below:
- absolute neutrophil count ≥750/mcL
- platelets ≥75,000/mcL
- total bilirubin < 2.0 x upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal or 5 X ULN
- if due to lymphoma infiltration
- creatinine 2.0 X ULN OR
- creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above 2.0 X ULN .
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts general Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Phase II Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma
This research study is studying Blinatumomab as a possible treatment for Indolent Non-Hodgkin Lymphoma (NHL).
Read the detailed description
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.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- Blinatumomab
- Keywords
- Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Also called Blincyto
Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab | Experimental | 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. Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Count of participants achieving a complete or partial response according to the revised response criteria for malignant lymphoma (2014).
A complete response is defined as regression of involved nodes to normal size (1.5 cm or less in their greatest transverse diameter for nodes 1.5 cm or greater before therapy). Involved nodes 1.1 - 1.5 cm in their greatest transverse diameter before treatment must have decreased to less than 1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD). For a complete response, the spleen, if enlarged before therapy on a CT scan, must also have regressed in size and must not be palpable.
A partial response is defined as 50% or greater decrease in SPD of up to 6 largest dominant masses. There must also be no new sites of disease or increases in the size of the other nodes, liver, or spleen. Splenic/hepatic nodules must regress by at least 50% in SPD.
Measured: at completion of treatment (6 months)
Secondary outcomes (5)
Progression Free Survival
Progression free survival is defined as the duration of time from start of treatment to time of documentation of disease progression according to the revised response criteria for malignant lymphoma (2014), death, or loss to follow-up. Progressive disease is defined as appearance of a new PET positive lesion greater than 1.5 cm in any axis, 50% or greater increase in the sum of the products of the greatest diameters (SPD) of more than one node, 50% or greater increase in longest diameter of a previously identified node less than 1 cm in short axis. There must also be a 50% increase from nadir in the SPD of any previous lesions.
Measured: 5 years
Time To Response Rate
Time to response is defined as the duration of time from start of treatment to the achievement of a complete response (CR) or partial response (PR) according to the revised response criteria for malignant lymphoma (2014).
A CR is defined as regression of involved nodes to normal size (1.5 cm or less in their greatest transverse diameter for nodes 1.5 cm or greater before therapy). Involved nodes 1.1 - 1.5 cm in their greatest transverse diameter before treatment must have decreased to less than 1 cm in this measure after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD). For a CR, the spleen, if enlarged before therapy on a CT scan, must also have regressed in size and must not be palpable.
A PR is defined as 50% or greater decrease in SPD of up to 6 largest dominant masses. There must also be no new sites of disease or increases in the size of the other nodes, liver, or spleen. Splenic/hepatic nodules must regress by at least 50% in SPD.
Measured: 4 months
Duration of Response
Duration of response is defined as the time from response (complete or partial response according to the revised response criteria for malignant lymphoma 2014) to disease progression, death, or loss to follow-up.
Measured: 5 years
Rate Patients Are Discontinued From The Drug Due to Toxicity
Number of patients who discontinued study treatment early due to one or more toxicities.
Measured: 2 years
Overall Survival
Overall survival is defined the duration of time from start of treatment to time of death or loss to follow up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion27 Jan 2020
- Study completionDec 2023
Why it stopped: Study closed early due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Jeffrey Barnes, Massachusetts General Hospital
- Investigators
- Jeffrey Barnes, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811679
- Sponsor's protocol ID
- 16-118
- Status last verified
- May 2025
- First submitted
- 21 Jun 2016
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT02811679
- Acronym / sponsor ID
- 16-118
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed early due to slow accrual
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Aug 2016 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying Blinatumomab as a possible treatment for Indolent Non-Hodgkin Lymphoma (NHL).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab | Experimental | Drug: BlinatumomabBlinatumomab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects must have histologically determined B cell NHL that is relapsed or primary refractory after initial therapy.
- At least 1 prior line of chemoimmunotherapy if primary refractory or relapsed with in one year. Subjects who respond to initial therapy for greater than one year must have had at least 2 prior lines of therapy including one line with chemoimmunotherapy including an anti-CD20 monoclonal antibody
- Measurable disease that has not been previously irradiated on PET-CT of at least 1.5cm,
- Age ≥18 years.
- ECOG performance status ≤2 ( see Appendix A)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlinatumomabAlso: BlincytoBlinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia | Drug | Blinatumomab |
Primary outcome
Overall Response Rate (ORR)
Time frame: at completion of treatment (6 months)
Count of participants achieving a complete or partial response according to the revised response criteria for malignant lymphoma (2014). A complete response is defined as regression of involved nodes to normal size (1.5 cm or less in their greatest transverse diameter for nodes 1.5 cm or greater before therapy). Involved nodes 1.1 - 1.5 cm in their greatest transverse diameter before treatment must have decreased to less than 1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD). For a complete response, the spleen, if enlarged before therapy on a CT scan, must also have regressed in size and must not be palpable. A partial response is defined as 50% or greater decrease in SPD of up to 6 largest dominant masses. There must also be no new sites of disease or increases in the size of the other nodes, liver, or spleen. Splenic/hepatic nodules must regress by at least 50% in SPD.
5 secondary outcomes
Progression Free Survival
Time frame: 5 years
Time To Response Rate
Time frame: 4 months
Duration of Response
Time frame: 5 years
Rate Patients Are Discontinued From The Drug Due to Toxicity
Time frame: 2 years
Overall Survival
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Barnes, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blinatumomab in people with Non-Hodgkin Lymphoma, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: at completion of treatment (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.