A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma

NCT02811679 | Terminated Phase 2 Results DMC

• 1 other identifier: 16-118
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying Blinatumomab as a possible treatment for Indolent Non-Hodgkin Lymphoma (NHL).

Conditions

Non-Hodgkin Lymphoma

Keywords

Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  at completion of treatment (6 months)

Secondary Outcomes (5)

• Progression Free Survival

  5 years

• Time To Response Rate

  4 months

• Duration of Response

  5 years

• Rate Patients Are Discontinued From The Drug Due to Toxicity

  2 years

• Overall Survival

  5 years

Study Arms (1)

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.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia

Also known as: Blincyto

Blinatumomab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Amgen: collaborator

Study Sites (1)

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

The study plan was to enroll 28 subjects, but only 13 subjects were enrolled due to slow accrual and early study closure.

Results Point of Contact

• Title: Jeffrey Barnes, MD, PhD
• Organization: Massachusetts General Hospital

JABARNES@mgh.harvard.edu

6177244000

Study Officials

• Jeffrey Barnes, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: August 1, 2016
• Primary Completion: January 27, 2020
• Study Completion: December 1, 2023
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)