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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 belowSelect...
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.
Select...
My blood tests show my bone marrow is working well.
Select...
My organs are working well according to recent tests.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at end of follow-up (1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at end of follow-up (1 year)
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 moreSide effects data
From 2022 Phase 2 trial • 145 Patients • NCT0358946942%
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%
Hypocalcaemia
8%
Tachycardia
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%
Thrombosis
1%
Deep vein thrombosis
1%
Haematoma
1%
Haemoptysis
1%
Syncope
1%
Confusional state
1%
Embolism
1%
Mental status changes
1%
Intentional self-injury
1%
Postoperative hypotension
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
~1990
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control and not donate sperm.I can take care of myself but might not be able to do heavy physical work.My organs are working well according to recent tests.I will have a stem cell transplant using my own cells within 30 days before starting the study drug.I had a stem cell transplant from a donor within the last 60 days.I cannot take drugs by mouth due to a digestive condition.I do not have any uncontrolled health conditions.I have experienced tumor breakdown without treatment.I have not taken certain substances 3 days before starting the study drug.I am HIV positive and need anti-viral treatment.I am not taking strong CYP3A inhibitors or inducers.I have had at least 2 treatments for my lymphoma.My side effects from previous treatments are mild.I am not pregnant or breastfeeding.I have been diagnosed with non-Hodgkin lymphoma, not including small lymphocytic lymphoma/chronic lymphocytic leukemia.My blood tests show my bone marrow is working well.
Research Study Groups:
This trial has the following groups:- Group 1: Loncastuximab tesirine & venetoclax
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current capacity of this research endeavor?
"That is correct. The clinicaltrials.gov page for this trial reveals that participant recruitment began on September 1st 2022, with the most recent update occurring in May of 2023. At present, 36 participants are being sought from a single site."
Answered by AI
Has additional research been conducted on Loncastuximab tesirine?
"At the moment, there are 29 Phase 3 trials and a total of 225 live studies assessing Loncastuximab tesirine. The majority of these investigations are close to Suzhou, Jiangsu; however, in all there exists 7341 sites that have active research on this drug."
Answered by AI
Has Loncastuximab tesirine obtained the endorsement of official regulatory bodies?
"Given its Phase 1 designation, Loncastuximab tesirine's safety has been rated as a measly "1" due to limited data available on both efficacy and security."
Answered by AI
What results are expected from this trial's implementation?
"This medical trial will evaluate the dose-limiting toxicities of loncastuximab tesirine and venetoclax over a 6 week period. The secondary objectives consist primarily of an overall response rate (ORR) based on complete or partial response, duration of response (DOR), and ORR as assessed by revised Response Criteria for Malignant Lymphoma."
Answered by AI
Are there opportunities to join the trial for those seeking treatment?
"Available information indicates that recruiting for this trial is still ongoing. The study was first published on September 1st 2022 and subsequently modified on May 20th of the same year."
Answered by AI
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