Loncastuximab tesirine for Follicular Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Miami, Miami, FLFollicular LymphomaLoncastuximab tesirine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it's more effective than the current standard of care for treating follicular lymphoma.

Eligible Conditions
  • Follicular Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 3 years

12 weeks
Number of participants achieving Complete Response (CR)
Up to 13 months
Incidence of Treatment-Related Adverse Events
Up to 3 years
Overall Survival (OS)
Progression-free Survival (PFS)
Week 12
Number of participants achieving CR or PR

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Loncastuximab Tesirine
41%Gamma-glutamyltransferase increased
39%Neutropenia
33%Thrombocytopenia
27%Fatigue
26%Anaemia
23%Nausea
21%Cough
20%Blood alkaline phosphatase increased
19%Oedema peripheral
17%Diarrhoea
17%Pyrexia
16%Alanine aminotransferase increased
16%Aspartate aminotransferase increased
16%Hypophosphataemia
15%Decreased appetite
15%Hypokalaemia
14%Leukopenia
14%Hypomagnesaemia
13%Vomiting
13%Rash
12%Constipation
12%Dyspnoea
12%Pruritus
11%Insomnia
10%Abdominal pain
10%Asthenia
10%Photosensitivity reaction
10%Headache
10%Erythema
9%Pleural effusion
8%Lymphopenia
8%Tachycardia
8%Hyperglycaemia
8%Hypocalcaemia
7%Weight increased
7%Hypotension
6%Neck pain
6%Hyponatraemia
6%Back pain
6%Pain in extremity
6%Dizziness
6%Hypertension
6%Rash maculo-papular
4%Hypercalcaemia
3%Febrile neutropenia
1%Pneumonia fungal
1%Mental status changes
1%Confusional state
1%Hydronephrosis
1%Ureterolithiasis
1%Thrombosis
1%Pericardial effusion
1%Pain
1%Pericarditis
1%Urinary tract infection bacterial
1%Pneumonia
1%Rhinovirus infection
1%Pleuritic pain
1%Escherichia sepsis
1%Ascites
1%Fall
1%Non-cardiac chest pain
1%Influenza
1%Small intestinal perforation
1%Small intestinal obstruction
1%Metapneumovirus infection
1%Disease progression
1%Klebsiella infection
1%Dysphagia
1%Intestinal obstruction
1%Syncope
1%Face oedema
1%Lung infection
1%Sepsis
1%Psychomotor skills impaired
1%Acute kidney injury
1%Pneumonitis
1%Deep vein thrombosis
1%Embolism
1%Septic shock
1%Soft tissue infection
1%Dehydration
1%Diffuse large B-cell lymphoma
1%Facial nerve disorder
1%Haemoptysis
1%Haematoma
1%Intentional self-injury
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03589469) in the Loncastuximab Tesirine ARM group. Side effects include: Gamma-glutamyltransferase increased with 41%, Neutropenia with 39%, Thrombocytopenia with 33%, Fatigue with 27%, Anaemia with 26%.

Trial Design

1 Treatment Group

Loncastuximab tesirine + Rituximab
1 of 1

Experimental Treatment

39 Total Participants · 1 Treatment Group

Primary Treatment: Loncastuximab tesirine · No Placebo Group · Phase 2

Loncastuximab tesirine + RituximabExperimental Group · 2 Interventions: Rituximab, Loncastuximab tesirine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Loncastuximab tesirine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

Juan P. Alderuccio, MDLead Sponsor
ADC Therapeutics S.A.Industry Sponsor
25 Previous Clinical Trials
1,909 Total Patients Enrolled
Juan P Alderuccio, MDPrincipal InvestigatorUniversity of Miami

Eligibility Criteria

Age 18+ · All Participants · 24 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have follicular lymphoma that has come back or not responded to at least one previous treatment and your condition meets certain criteria for needing further treatment.
You have an enlarged spleen or a lesion in your spleen.
You have had a relapse or progression of your second FL (Follicular Lymphoma) after trying at least one systemic treatment.
You have unexplained fever, night sweats, or have lost more than 10% of your body weight in the past 6 months.
You have a high risk of experiencing symptoms that could compress your organs and affect their function.
Your doctor thinks you will live for at least 6 more weeks.

Frequently Asked Questions

What therapeutic applications is Loncastuximab tesirine typically employed for?

"Loncastuximab tesirine is the recommended treatment for diffuse large b-cell lymphoma (DLBCL). However, it has been found efficacious in combatting relapsed large B cell lymphomas, other B-cell neoplasms and polyangiitis." - Anonymous Online Contributor

Unverified Answer

Are new participants being enrolled in this research endeavor?

"If the information on clinicaltrials.gov is accurate, then this medical trial is presently recruiting patients. It was first announced on February 11th 2022 and its details were last amended on July 11th of the same year." - Anonymous Online Contributor

Unverified Answer

What is the current participant recruitment rate of this clinical trial?

"Affirmative, the information provided on clinicaltrials.gov confirms that this medical experiment is actively enrolling participants. This research was first posted on 2/11/2022 and has been recently modified on 7/11/2022; 39 patients need to be recruited from 1 hospital setting." - Anonymous Online Contributor

Unverified Answer

How securely does Loncastuximab tesirine protect patients from harm?

"While Loncastuximab tesirine has not demonstrated efficacy in clinical trials, there is some safety data to suggest that it should receive a score of 2." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.