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BiTE Antibody

Blinatumomab for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Jeffrey Barnes, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is studying how well Blinatumomab works in treating patients with indolent NHL.

Eligible Conditions

Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate

Secondary outcome measures

Duration of Response

Overall Survival Rate

Progression Free Survival Rate

+2 more

Side effects data

From 2022 Phase 3 trial • 111 Patients • NCT02393859

80%

Pyrexia

43%

Nausea

37%

Headache

31%

Vomiting

24%

Anaemia

22%

Diarrhoea

20%

Stomatitis

17%

Mucosal inflammation

13%

Rash

13%

Abdominal pain

13%

Platelet count decreased

13%

Hypertension

11%

Pruritus

11%

Erythema

11%

Hypokalaemia

11%

Hypogammaglobulinaemia

11%

Hypotension

Neutropenia

Tremor

Epistaxis

Constipation

Neutrophil count decreased

Agitation

White blood cell count decreased

Immunodeficiency

Hypervolaemia

Alanine aminotransferase increased

Anal inflammation

Cough

Thrombocytopenia

Abdominal pain upper

Petechiae

Fluid overload

Rash maculo-papular

Decreased appetite

Fatigue

Paronychia

Back pain

Nasopharyngitis

Febrile neutropenia

Urticaria

Fluid balance positive

Seizure

Oropharyngeal pain

Aplasia

Pain in extremity

Neurological symptom

Aspartate aminotransferase increased

Haematoma

Herpes virus infection

Klebsiella infection

Accidental overdose

Nervous system disorder

Perineal cellulitis

Catheter placement

Engraftment syndrome

Complication associated with device

Oral pain

Neurological examination abnormal

Blood immunoglobulin G decreased

Antithrombin III decreased

Laryngotracheitis obstructive

Pain

Hypertransaminasaemia

Rhinitis

Body temperature increased

100%

80%

60%

40%

20%

Study treatment Arm

Blinatumomab

HC3 Chemotherapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: BlinatumomabExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blinatumomab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor

1,370 Previous Clinical Trials

1,377,675 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,342 Total Patients Enrolled

Jeffrey Barnes, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Blinatumomab (BiTE Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT02811679 — Phase 2

Non-Hodgkin's Lymphoma Research Study Groups: Blinatumomab

Non-Hodgkin's Lymphoma Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT02811679 — Phase 2

Blinatumomab (BiTE Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02811679 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Blinatumomab received government approval for use?

"While there is some data supporting Blinatumomab's safety, it is still classified as a Phase 2 drug because there is no evidence of efficacy. Therefore, it received a score of 2."

Answered by AI

Could you list some of the other research done on Blinatumomab?

"There are 47 different medical trials testing blinatumomab with 10 of them being in the final stage, phase 3. Most of these studies originate from Baltimore, Maryland; however, there are 2492 locations running these tests."

Answered by AI

How many test subjects are required for this clinical trial?

"This clinical trial is not actively looking for participants at this time. The study was originally posted on 8/1/2016 and was last updated on 1/31/2021. If you are searching for other studies, there are presently 1821 studies actively admitting patients with non-hodgkin's lymphoma (nhl) and 47 trials for Blinatumomab actively enrolling participants."

Answered by AI

Are people still being accepted into the program?

"The clinical trial mentioned is not currently looking for new participants. This can be deduced from the dates on clinicaltrials.gov, which show that the last update was on January 31st, 2021. Despite this study being concluded, there are 1,868 other trials seeking patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jeffrey Barnes 2016. "A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02811679.