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Bispecific T-cell Engager (BiTE)

Blinatumomab for B-Cell Lymphoma (HARBOUR Trial)

Phase 1
Waitlist Available
Research Sponsored by Amgen
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 from first dose of blinatumomab up to the data cut-off date of 17 november 2020; maximum time on follow-up was 3.3 months.
Awards & highlights

HARBOUR Trial Summary

This trial is testing a new combination of drugs to see what the maximum tolerated dose is for adults with relapsed or refractory DLBCL.

Eligible Conditions
  • Diffuse Large B Cell Lymphoma (DLBCL)

HARBOUR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of blinatumomab up to the data cut-off date of 17 november 2020; maximum time on follow-up for pfs was 24.4, 16.4, and 6.7 months in each cohort, respectively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of blinatumomab up to the data cut-off date of 17 november 2020; maximum time on follow-up for pfs was 24.4, 16.4, and 6.7 months in each cohort, respectively. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Blinatumomab Clearance
Blinatumomab Steady State Concentration
Complete Response Rate During the First 12 Weeks Using the Lugano Classification
+14 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
9%
Neutropenia
9%
Tremor
9%
Epistaxis
9%
Constipation
9%
Neutrophil count decreased
7%
White blood cell count decreased
7%
Immunodeficiency
7%
Agitation
7%
Hypervolaemia
7%
Alanine aminotransferase increased
7%
Anal inflammation
7%
Cough
7%
Thrombocytopenia
7%
Abdominal pain upper
7%
Petechiae
7%
Fluid overload
6%
Decreased appetite
6%
Fatigue
6%
Rash maculo-papular
6%
Paronychia
6%
Back pain
6%
Nasopharyngitis
6%
Febrile neutropenia
6%
Urticaria
4%
Fluid balance positive
4%
Seizure
4%
Oropharyngeal pain
4%
Aplasia
4%
Pain in extremity
4%
Neurological symptom
4%
Aspartate aminotransferase increased
2%
Haematoma
2%
Herpes virus infection
2%
Klebsiella infection
2%
Accidental overdose
2%
Nervous system disorder
2%
Perineal cellulitis
2%
Catheter placement
2%
Engraftment syndrome
2%
Complication associated with device
2%
Oral pain
2%
Neurological examination abnormal
2%
Blood immunoglobulin G decreased
2%
Antithrombin III decreased
2%
Laryngotracheitis obstructive
2%
Pain
2%
Hypertransaminasaemia
2%
Rhinitis
2%
Body temperature increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Blinatumomab
HC3 Chemotherapy

HARBOUR Trial Design

4Treatment groups
Experimental Treatment
Group I: Expansion CohortExperimental Treatment2 Interventions
This cohort will test the maximum tolerated dose of blinatumomab in combination with pembrolizumab identified in Part 1 of the study.
Group II: Cohort Ia: Blinatumomab 9/28 µg/day + PembrolizumabExperimental Treatment2 Interventions
Participants received blinatumomab administered as a continuous intravenous infusion (CIVI) for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days then 28 µg/day for the remaining days of treatment. Starting on Day 15 participants also received 200 mg pembrolizumab administered by intravenous (IV) infusion every 3 weeks (Q3W) until disease progression or for up to 35 cycles.
Group III: Cohort IIa: Blinatumomab 9/28/56 µg/day + PembrolizumabExperimental Treatment2 Interventions
Participants received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 56 µg/day for the remaining days of treatment. Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles.
Group IV: Cohort IIIa: Blinatumomab 9/28/112 µg/day + PembrolizumabExperimental Treatment2 Interventions
Participants received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 112 µg/day for the remaining days of treatment. Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
2014
Completed Phase 3
~1210
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,657 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,522 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
924,100 Total Patients Enrolled

Frequently Asked Questions

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

What qualifications do participants need to meet in order to join this research project?

"This clinical trial seeks to recruit 31 qualified individuals diagnosed with lymphoma, aged between 18 and 100 years old. To be accepted as a participant of this study, one must meet the following parameters: having an ECOG performance status at or below 2; exhibiting signs of advanced illness that indicate life expectancy in excess of 12 weeks; biopsy-proven diffuse large B cell lymphoma (DLBCL); refractory after receiving either systemic chemotherapy/targeted therapy or relapsed post autologous/allogeneic hematopoietic stem cell transplantation (HSCT) whilst satisfying organ function criteria; measurable disease present. Additional"

Answered by AI

In which maladies is Blinatumomab typically employed?

"Blinatumomab is often used to treat malignant tumours, but it may also be effective for unresectable melanoma, microsatellite instability high and refractory B-cell precursor acute lymphoblastic leukemias."

Answered by AI

What is the ultimate goal of this trial?

"The primary measure of success for this study, over the course of up to 63 days, is determining how many participants experience Dose Limiting Toxicities (DLTs). Secondary outcomes revolve around Blinatumomab Steady State Concentration, Objective Response Rate During the First 12 Weeks Using Revised Response Criteria and Objective Response Rate During the Treatment Period Using the Lugano Classification."

Answered by AI

Have prior investigations employed Blinatumomab as a therapeutic agent?

"Presently, Blinatumomab is being evaluated in 1007 live trials with 131 of these studies at the Phase 3 level. Of all 38144 clinical research sites running tests for this biologic agent, most are based out of Houston Texas."

Answered by AI

What is the current number of participants for this clinical investigation?

"This investigation is not presently considering any new candidates. It was initially announced on March 16th 2018 and last edited on December 7 2021. If you are exploring your options, there are currently 1767 clinical studies actively seeking out lymphoma patients and 1007 taking in Blinatumomab applicants."

Answered by AI

What safety precautions must be taken when administering Blinatumomab to patients?

"There is limited clinical evidence to support Blinatumomab's efficacy and safety, thus it has been given a score of 1."

Answered by AI

Is enrollment for this experiment currently available?

"Unfortunately, no further patients are being accepted for this research trial. It was first posted on March 16th 2018 and the most recent update was December 7th 2021. Fortunately, there is still ample opportunity to participate in other medical studies; 1767 clinical trials related to lymphoma and 1007 involving Blinatumomab currently remain open for enrollment."

Answered by AI

Is this clinical research open to adults below the retirement age?

"Candidates between the ages of 18 and 100 are eligible to participate in this clinical trial. For those below 18, there are 348 separate studies available while 2,591 trials exist for persons over 65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
2018. "Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03340766.
~4 spots leftby Apr 2025
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