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Monoclonal Antibodies
Loncastuximab Tesirine + Rituximab for Follicular Lymphoma
Phase 2
Recruiting
Led By Juan P Alderuccio, MD
Research Sponsored by Juan P. Alderuccio, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Patients must have histologic confirmation of Follicular Lymphoma (FL) (grade 1, 2 and 3A). Participants who have received previous CD19-directed therapy must have a biopsy showing CD19 expression after completion of the therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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.
Who is the study for?
Adults diagnosed with Follicular Lymphoma who have relapsed or not responded to treatment, and show certain disease characteristics on scans. They must be in relatively good health otherwise, with major organs functioning well and no severe illnesses that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing whether combining Loncastuximab Tesirine with Rituximab increases the complete response rate in treating Follicular Lymphoma compared to previous treatments patients may have received.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, lowered blood cell counts which can increase infection risk, liver enzyme changes suggesting liver stress, and possibly other organ-related inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have a confirmed diagnosis of Follicular Lymphoma and if treated before, my cancer still shows CD19.
Select...
My blood test shows more than 5,000 lymphoma cells per mm3.
Select...
I have at least 3 lymph nodes, each larger than 3 cm.
Select...
My organ and bone marrow functions are normal.
Select...
I meet at least one criterion for starting treatment based on my lymphoma condition.
Select...
I have a tumor that is 7 cm or larger.
Select...
My scans show cancer that can be measured.
Select...
I have had unexplained fever, night sweats, or significant weight loss recently.
Select...
I have an enlarged spleen or a spleen lesion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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 achieving Complete Response (CR)
Secondary outcome measures
Incidence of Treatment-Related Adverse Events
Number of participants achieving CR or PR
Overall Survival (OS)
+1 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%
Haematoma
1%
Haemoptysis
1%
Syncope
1%
Confusional state
1%
Embolism
1%
Mental status changes
1%
Intentional self-injury
1%
Deep vein thrombosis
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 + RituximabExperimental Treatment2 Interventions
During the 12-week Induction Phase (Cycles 1 to 4), participants will receive loncastuximab tesirine on days 1 of each 3-week cycle for Cycles 1 through 4; and rituximab on days 1, 8, 15 of Cycle 1 and day 1 of Cycle 2.
Maintenance Phase 1 (Cycle 5) is 8 weeks: Participants achieving complete response (CR) or partial response (PR) during the Induction Phase will receive loncastuximab tesirine once every 3-weeks; and rituximab once during week 7 or 8. Participants achieving a response of Stable Disease (SD) or Progressive Disease (PD) will be taken off treatment.
Maintenance Phase 2 (Cycles 6 and 7) is 16 weeks:
Participants achieving CR during Maintenance Phase 1 receive rituximab once during week 7 or 8 of Cycles 6 and 7.
Participants achieving PR during Maintenance Phase 1 receive loncastuximab tesirine once every 3-weeks over each 8 week cycle; and rituximab once during week 7 or 8 of Cycles 6 and 7.
Participants achieving SD or PD will be taken off treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Loncastuximab tesirine
2018
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
Juan P. Alderuccio, MDLead Sponsor
ADC Therapeutics S.A.Industry Sponsor
28 Previous Clinical Trials
2,194 Total Patients Enrolled
Juan P Alderuccio, MDPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.I have a confirmed diagnosis of Follicular Lymphoma and if treated before, my cancer still shows CD19.My blood test shows more than 5,000 lymphoma cells per mm3.I have at least 3 lymph nodes, each larger than 3 cm.My cancer returned or worsened within 24 months after starting treatment.My organ and bone marrow functions are normal.I have a history of HIV.I have hepatitis but my PCR test for it is negative.I meet at least one criterion for starting treatment based on my lymphoma condition.My follicular lymphoma has returned or didn't respond to treatment, and I've had at least one treatment before.I do not have severe heart, liver, autoimmune issues, or a recent stroke.My condition is either Follicular Lymphoma grade 3B or transformed Follicular Lymphoma.I have a tumor that is 7 cm or larger.My follicular lymphoma has worsened after at least one treatment.I have fluid buildup needing drainage or causing breathing problems.My scans show cancer that can be measured.I am unable to make medical decisions for myself.My lymphoma has spread to my brain or spinal cord.I have had unexplained fever, night sweats, or significant weight loss recently.My tumor might press on nearby organs.I have an enlarged spleen or a spleen lesion.I am 18 years old or older.I have undergone 6 or more treatments for follicular lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Loncastuximab tesirine + Rituximab
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 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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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