Rituximab for Diffuse Large B-cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diffuse Large B-cell LymphomaRituximab - Drug
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Diffuse Large B-cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 12 Secondary · Reporting Duration: Up to 5.5 years

Week 22
Number of Participants with a Change from Baseline in Patient-reported Outcomes
Number of Participants with a Clinically Significant Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Up to 12 weeks
Cohort B, Part 1: Percentage of Participants Completing 4 Cycles of Treatment
Cohort B: Percentage of Participants Completing 4 Cycles of Treatment
Up to 2 years
2-year Progression-free Survival (PFS)
Cohort A, Part 1: 2-years PFS
Cohorts A and B, Part 2: 2-year Progression Free Survival (PFS)
Number of Participants with Confirmed Positive Anti-Drug Antibody (ADA) Responses
Serum Concentration of Loncastuximab Tesirine Pyrrolobenzodiazepine (PBD)-conjugated Antibody
Serum Concentration of SG3199 Unconjugated Warhead
Serum Concentration of Total Antibody
Up to 22 weeks
Overall Response Rate (ORR)
Up to 3 years
3-year Overall Survival (OS)
Up to 5.5 years
CR Rate
Duration of Response (DoR)
Number of Participants who Experience a Treatment-emergent Adverse Event

Trial Safety

Safety Progress

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

Side Effects for

Rituximab
8%Mild/moderate allergic reactions
3%Severe allergic reaction
This histogram enumerates side effects from a completed 2016 Phase 2 & 3 trial (NCT03002038) in the Rituximab ARM group. Side effects include: Mild/moderate allergic reactions with 8%, Severe allergic reaction with 3%.

Trial Design

6 Treatment Groups

Cohort A, Part 2: R-mini-CHOP
1 of 6
Cohort B : Loncastuximab Tesirine + Rituximab (Lonca-R)
1 of 6
Cohort B, Part 1 and Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R)
1 of 6
Cohort A, Part 1: Loncastuximab Tesirine + Rituximab (Lonca-R)
1 of 6
Cohort A, Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R)
1 of 6
Cohort A : Loncastuximab Tesirine + Rituximab (Lonca-R)
1 of 6

Active Control

Experimental Treatment

80 Total Participants · 6 Treatment Groups

Primary Treatment: Rituximab · No Placebo Group · Phase 2

Cohort B : Loncastuximab Tesirine + Rituximab (Lonca-R)Experimental Group · 2 Interventions: Loncastuximab Tesirine, Rituximab · Intervention Types: Drug, Drug
Cohort B, Part 1 and Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R)Experimental Group · 2 Interventions: Loncastuximab Tesirine, Rituximab · Intervention Types: Drug, Drug
Cohort A, Part 1: Loncastuximab Tesirine + Rituximab (Lonca-R)Experimental Group · 2 Interventions: Loncastuximab Tesirine, Rituximab · Intervention Types: Drug, Drug
Cohort A, Part 2: Loncastuximab Tesirine + Rituximab (Lonca-R)Experimental Group · 2 Interventions: Loncastuximab Tesirine, Rituximab · Intervention Types: Drug, Drug
Cohort A : Loncastuximab Tesirine + Rituximab (Lonca-R)Experimental Group · 2 Interventions: Loncastuximab Tesirine, Rituximab · Intervention Types: Drug, Drug
Cohort A, Part 2: R-mini-CHOPActiveComparator Group · 5 Interventions: Cyclophosphamide, Prednisone, Vincristine, Doxorubicin, Rituximab · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Loncastuximab tesirine
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5.5 years

Who is running the clinical trial?

ADC Therapeutics S.A.Lead Sponsor
25 Previous Clinical Trials
1,868 Total Patients Enrolled

Eligibility Criteria

Age 65+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a pathologic diagnosis of DLBCL, as defined by the 2016 WHO classification (including participants with DLBCL transformed from indolent lymphoma), or HGBCL, or Grade 3b FL.
You have a disease or condition that is measurable by the 2014 Lugano Classification.
ANC > 1.0 x 10^3/µL (off growth factors at least 72 hours).
Platelet count ≥75 x 10^3/µL without transfusion in the past 7 days.
You have a total bilirubin level of ≤1.5 x ULN.
Creatinine clearance >30 mL/min.