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Alkylating agents

Loncastuximab Tesirine + Rituximab for Diffuse Large B-Cell Lymphoma (LOTIS-9 Trial)

Phase 2
Waitlist Available
Research Sponsored by ADC Therapeutics S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologic diagnosis of DLBCL, as defined by the 2016 World Health Organization (WHO) classification (including participants with DLBCL transformed from indolent lymphoma), or HGBCL, or Grade 3b FL.
-- ADL score of 6
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5.5 years
Awards & highlights

LOTIS-9 Trial Summary

This trial is testing a new drug to see if it is effective and safe in patients with a specific type of cancer who are either unfit or frail.

Who is the study for?
This trial is for older adults who are unfit or frail with untreated Diffuse Large B-cell Lymphoma (DLBCL). They must have measurable disease, be in stages I-IV, and have adequate organ function. Participants should not have had previous DLBCL treatments, no severe allergies to the drugs being tested, and agree to contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial tests a combination of two drugs: Loncastuximab Tesirine and Rituximab (Lonca-R), assessing their effectiveness and safety in patients who haven't been treated before for DLBCL but are considered unfit or frail due to age or health conditions.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components, liver enzyme elevations, blood disorders like low platelet counts or neutrophils, fatigue, possible heart complications in those with pre-existing conditions.

LOTIS-9 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

LOTIS-9 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CR Rate
Cohort B: Percentage of Participants Completing 4 Cycles of Treatment
Secondary outcome measures
2-year Progression-free Survival (PFS)
3-year Overall Survival (OS)
Duration of Response (DoR)
+8 more

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038
4%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab

LOTIS-9 Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B : Loncastuximab Tesirine + Rituximab (Lonca-R)Experimental Treatment2 Interventions
Participants who are frail (per sGA) or participants with cardiac comorbidities will receive Lonca-R for 3 cycles. Participants who achieve a CR will receive Lonca-R for 1 additional cycle. Participants who achieve a PR will receive Lonca-R for 3 additional cycles for a total of up to 6 cycles. Only participants enrolled in Cohort B, who achieve stable disease (SD) and deriving clinical benefit per the treating physician, may also receive Lonca-R for an additional 3 cycles. Lonca-R will be administered as rituximab 375 mg/m^2 on Day 1 of Cycle 1 and loncastuximab tesirine 150 µg/kg on Day 2 of Cycle 1. During Cycle 2, Lonca-R will be administered as rituximab* 375 mg/m^2 and loncastuximab tesirine 150 µg/kg on Day 1. For cycles 3 and beyond, Lonca-R will be administered as rituximab 375 mg/m^2 and loncastuximab tesirine 75 µg/kg on Day 1. *subcutaneous rituximab 1400mg/dose may be used during Cycle 2 and beyond
Group II: Cohort A : Loncastuximab Tesirine + Rituximab (Lonca-R)Experimental Treatment2 Interventions
Participants who are unfit (per sGA) will receive Lonca-R for 3 cycles. Participants who achieve a complete response (CR) will receive Lonca-R for 1 additional cycle. Participants who achieve a partial response (PR) will receive Lonca-R for 3 additional cycles. Lonca-R will be administered as rituximab 375 mg/m^2 on Day 1 of Cycle 1 and loncastuximab tesirine 150 µg/kg on Day 2 of Cycle 1. During Cycle 2, Lonca-R will be administered as rituximab* 375 mg/m^2 and loncastuximab tesirine 150 µg/kg on Day 1. For cycles 3 and beyond, Lonca-R will be administered as rituximab 375 mg/m^2 and loncastuximab tesirine 75 µg/kg on Day 1. *subcutaneous rituximab 1400mg/dose may be used during Cycle 2 and beyond
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Loncastuximab Tesirine
2022
Completed Phase 2
~50
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

ADC Therapeutics S.A.Lead Sponsor
28 Previous Clinical Trials
2,192 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05144009 — Phase 2
Diffuse Large B-Cell Lymphoma Research Study Groups: Cohort B : Loncastuximab Tesirine + Rituximab (Lonca-R), Cohort A : Loncastuximab Tesirine + Rituximab (Lonca-R)
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05144009 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05144009 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any availability for patients to take part in the experiment?

"As per the records available on clinicaltrials.gov, this medical study is still open for patient enrolment. The original posting date of this trial was June 21st 2022 while its last update came in November 2nd 2022."

Answered by AI

What circumstances is Rituximab frequently employed to treat?

"Rituximab is frequently prescribed for the treatment of lung malignancies, including small cell lung cancer. Additionally, it has proved to be a viable remedy for thyroiditis and polyangium."

Answered by AI

What is the current capacity of participants in this experimentation?

"The sponsor, ADC Therapeutics S.A., is mandating the recruitment of 80 qualified patients to continue with the study. Participants will be sourced from Virginia Cancer Specialists in Gainesville and Texas Oncology - Medical City Dallas in Dallas respectively."

Answered by AI

How widespread is the implementation of this research study in Canada?

"For this medical trial, Virginia Cancer Specialists, PC in Gainesville, Texas Oncology - Medical City Dallas in Dallas and Williamette Valley Cancer Institute and Research in Eugene are only three of the nine total sites offering participation."

Answered by AI

Could you elucidate other experiments that have utilized Rituximab?

"Currently, there are 1,431 trials being conducted to evaluate the efficacy of rituximab. Of those investigations, 311 have advanced to Phase 3 clinicals in 51783 sites across the globe; however, most studies for Rituximab are concentrated in Bethesda Maryland."

Answered by AI

Has Rituximab achieved regulatory authorization from the FDA?

"The safety of Rituximab is estimated to be a 2 due to the limited evidence that has been amassed in Phase 2 trials. While there are some data points supporting its security, none have yet verified efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)
2022. "A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05144009.
~15 spots leftby Apr 2025
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