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Monoclonal Antibodies

Loncastuximab Tesirine + Venetoclax for Non-Hodgkin's Lymphoma

Phase 1
Recruiting
Research Sponsored by Brian Hill, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have received ≥2 prior systemic therapies for their lymphoma
ECOG performance status ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at end of follow-up (1 year)
Awards & highlights

Study Summary

This trial is testing the safety of combining two new cancer drugs to treat relapsed or refractory B cell lymphoma.

Who is the study for?
This trial is for adults with Non-Hodgkin Lymphoma who've had at least two prior treatments and still have measurable disease. They must be in a stable condition, not pregnant or breastfeeding, willing to use effective contraception, and without serious unresolved treatment side effects from previous therapies.Check my eligibility
What is being tested?
The study tests combining loncastuximab tesirine with venetoclax to treat B cell lymphoma that has come back or hasn't responded to other treatments. The main focus is finding the right dose and checking if this drug combo is safe.See study design
What are the potential side effects?
Potential side effects of these drugs may include fatigue, nausea, diarrhea, low blood cell counts increasing infection risk, liver problems, and allergic reactions. Specific side effects related to the combination are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least 2 treatments for my lymphoma.
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I can take care of myself but might not be able to do heavy physical work.
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My blood tests show my bone marrow is working well.
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My organs are working well according to recent tests.
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I agree to use birth control and not donate sperm.
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I have been diagnosed with non-Hodgkin lymphoma, not including small lymphocytic lymphoma/chronic lymphocytic leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at end of follow-up (1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of follow-up (1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities (DLTs) during cycle 1 of loncastuximab tesirine and venetoclax
Maximum tolerated dose (MTD) of loncastuximab tesirine and venetoclax
Secondary outcome measures
Complete response rate (CRR)
Complete response rate (CRR) as measured by proportion of participants with CR
Duration of response (DOR)
+11 more

Side effects data

From 2022 Phase 2 trial • 145 Patients • NCT03589469
42%
Gamma-glutamyltransferase increased
40%
Neutropenia
33%
Thrombocytopenia
28%
Fatigue
26%
Anaemia
23%
Nausea
22%
Cough
20%
Blood alkaline phosphatase increased
19%
Oedema peripheral
17%
Diarrhoea
17%
Pyrexia
16%
Aspartate aminotransferase increased
16%
Hypokalaemia
16%
Hypophosphataemia
15%
Alanine aminotransferase increased
15%
Decreased appetite
14%
Hypomagnesaemia
14%
Leukopenia
13%
Vomiting
13%
Rash
13%
Pruritus
12%
Constipation
12%
Dyspnoea
11%
Abdominal pain
11%
Insomnia
10%
Asthenia
10%
Headache
10%
Erythema
10%
Photosensitivity reaction
10%
Pleural effusion
8%
Tachycardia
8%
Hypocalcaemia
8%
Hyperglycaemia
8%
Lymphopenia
7%
Weight increased
7%
Hypotension
6%
Nasal congestion
6%
Hyponatraemia
6%
Back pain
6%
Pain in extremity
6%
Neck pain
6%
Dizziness
6%
Rash maculo-papular
6%
Hypertension
4%
Hypercalcaemia
3%
Febrile neutropenia
1%
Haematoma
1%
Syncope
1%
Confusional state
1%
Deep vein thrombosis
1%
Embolism
1%
Intentional self-injury
1%
Haemoptysis
1%
Thrombosis
1%
Postoperative hypotension
1%
Mental status changes
1%
Pneumonia fungal
1%
Rhinovirus infection
1%
Diffuse large B-cell lymphoma
1%
Acute kidney injury
1%
Ureterolithiasis
1%
Pleuritic pain
1%
Pneumonitis
1%
Metapneumovirus infection
1%
Lung infection
1%
Facial nerve disorder
1%
Psychomotor skills impaired
1%
Hydronephrosis
1%
Pericardial effusion
1%
Pericarditis
1%
Ascites
1%
Dysphagia
1%
Intestinal obstruction
1%
Small intestinal obstruction
1%
Small intestinal perforation
1%
Non-cardiac chest pain
1%
Disease progression
1%
Face oedema
1%
Pain
1%
Pneumonia
1%
Escherichia sepsis
1%
Influenza
1%
Klebsiella infection
1%
Sepsis
1%
Septic shock
1%
Soft tissue infection
1%
Urinary tract infection bacterial
1%
Fall
1%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Loncastuximab Tesirine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Loncastuximab tesirine & venetoclaxExperimental Treatment2 Interventions
Participants will receive a baseline disease assessment via PET/CT in FDG avid lymphomas; CT scan (chest, abdomen, pelvis; inclusion of neck in selected cases). Bome marrow biopsy in selected cases. Premedication includes: Allopurinol (to reduce uric acid) 300mg orally daily starting day -1 and continuing at least until day 7 of each cycle. Dexamethasone (steroid pre-medication) 4mg orally twice daily on day -1, day 1 and day 2 of each cycle. Adequate oral hydration starting on day -1 or -2, defined as 1 - 2 liters of oral intake of liquids in 24 hours Study treatment to be given every 21 days. Loncastuximab tesirine (50 - 150 μg/kg) intravenously (IV) on day 1 of each 21-day cycle Venetoclax (400 - 800 mg) orally, every day on days 1 - 5 of each 21-day cycle. Dose ramp-up on cycle 1 (over days 1 - 5 for target dose 400mg, 1 - 6 for target dose 600mg and 1 - 7 for target dose 800mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Loncastuximab tesirine
2018
Completed Phase 2
~150
Venetoclax
2019
Completed Phase 3
~1950

Find a Location

Who is running the clinical trial?

Brian Hill, MD, PhDLead Sponsor
2 Previous Clinical Trials
49 Total Patients Enrolled
Brian HillLead Sponsor
1 Previous Clinical Trials
19 Total Patients Enrolled

Media Library

Loncastuximab Tesirine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05053659 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Loncastuximab tesirine & venetoclax
Non-Hodgkin's Lymphoma Clinical Trial 2023: Loncastuximab Tesirine Highlights & Side Effects. Trial Name: NCT05053659 — Phase 1
Loncastuximab Tesirine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05053659 — Phase 1
~12 spots leftby Jun 2025
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