Loncastuximab Tesirine for Diffuse Large B Cell Lymphoma (DLBCL)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Istituto Europeo di Oncologia, Milano, ItalyDiffuse Large B Cell Lymphoma (DLBCL)+1 MoreLoncastuximab Tesirine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare a new immunotherapy drug to the current standard of care for treating a certain type of blood cancer.

Eligible Conditions
  • Diffuse Large B Cell Lymphoma (DLBCL)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Loncastuximab Tesirine
1
Tiragolumab
1
Rituximab

Study Objectives

1 Primary · 18 Secondary · Reporting Duration: Up to 4 years

Year 4
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Week 25
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by GP5 Item of the Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym)
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Core 30 (EORTC QLQ-C30)
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by the Lymphoma Subscale of Functional Assessment of Cancer Therapy- Lymphoma (LymS of FACT-Lym)
Week 3
Average Concentration of Loncastuximab Tesirine at the End of Infusion
Week 3
Average Concentration of Loncastuximab Tesirine Before Infusion
Week 25
Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE)
Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results
Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECG) Results
Number of Participants Who Experience a Clinically Significant Change From Baseline in Physical Examinations
Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements
Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine
Up to 4 years
Complete Response Rate (CRR)
Duration of Response (DOR)
Number of Participants Who Experience At Least One Serious Adverse Event (SAE)
Overall Response Rate (ORR)
Overall Survival (OS)
Progression-free Survival (PFS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Loncastuximab Tesirine
1
Tiragolumab
2
Rituximab

Trial Design

3 Treatment Groups

Part 2: Standard Immunochemotherapy (R-GemOx)
1 of 3
Part 1: Loncastuximab Tesirine + Rituximab (Lonca-R)
1 of 3
Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R)
1 of 3

Active Control

Experimental Treatment

350 Total Participants · 3 Treatment Groups

Primary Treatment: Loncastuximab Tesirine · No Placebo Group · Phase 3

Part 1: Loncastuximab Tesirine + Rituximab (Lonca-R)Experimental Group · 2 Interventions: Loncastuximab Tesirine, Rituximab · Intervention Types: Drug, Drug
Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R)Experimental Group · 2 Interventions: Loncastuximab Tesirine, Rituximab · Intervention Types: Drug, Drug
Part 2: Standard Immunochemotherapy (R-GemOx)ActiveComparator Group · 3 Interventions: Oxaliplatin, Rituximab, Gemcitabine · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years

Who is running the clinical trial?

ADC Therapeutics S.A.Lead Sponsor
25 Previous Clinical Trials
1,598 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your cancer has come back or not responded to previous treatments with more than one medication.
References

Frequently Asked Questions

What is the status of Loncastuximab Tesirine's FDA approval?

"This clinical trial is a Phase 3, meaning that while there is data supporting efficacy, there is also multiple rounds of data supporting safety. Therefore, our team has given Loncastuximab Tesirine a safety score of 3." - Anonymous Online Contributor

Unverified Answer

What indications is Loncastuximab Tesirine commonly used to treat?

"Loncastuximab Tesirine is most commonly used to treat diffuse large b-cell lymphoma (dlbcl), but can also be used as part of the treatment plan for small cell lung cancer (sclc), head and neck carcinoma, and cervical cancers." - Anonymous Online Contributor

Unverified Answer

Are there still positions open for participants in this trial?

"This research study is currently recruiting patients, as indicated by the listing on clinicaltrials.gov. This trial was first announced on September 16th, 2020 with the last update on October 26th, 2020." - Anonymous Online Contributor

Unverified Answer

At how many locations is this experiment being conducted?

"To minimise the burden of travel on participants, the 17 clinical trial sites are located in La Jolla, Redlands, and Montréal as well as 14 other cities." - Anonymous Online Contributor

Unverified Answer

What is the background of Loncastuximab Tesirine in medical research?

"At present, there are 1164 concurrent clinical trials for Loncastuximab Tesirine globally, with the majority of these (336) being in Phase 3. The vast majority of these clinical trials are located in Guangzhou, Guangdong; however, there are 51462 total locations running studies for Loncastuximab Tesirine." - 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.

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