Actively Recruiting
Use of Loncastuximab Tesirine in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma or High-Grade B-Cell Lymphoma After CAR T-cell Treatment
Led by Istituto Clinico Humanitas · Updated on 2025-04-09
50
Participants Needed
7
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug Loncastuximab Tesirine for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) who have not responded to or have relapsed after CAR-T therapy. This Phase II single-arm clinical trial aims to determine if Loncastuximab Tesirine can improve the overall response rate and to assess its safety in this group with limited treatment options. The trial also explores biomarkers related to treatment response and disease progression. Participants receive Loncastuximab Tesirine through intravenous infusions every three weeks for up to eight cycles. The dosing starts at 150 bcg/kg for the first two cycles, followed by 75 bcg/kg for the remaining cycles, with each infusion lasting about 30 minutes. Patients are monitored closely during treatment for side effects, and their tumor response is evaluated using PET-CT or CT scans at several points during and after treatment. After completing therapy, participants are followed for up to two years to track long-term outcomes and safety. During the study, participants undergo regular assessments including blood tests, imaging scans, and biopsies for biomarker analysis before treatment begins. Researchers track response rates, progression-free survival, overall survival, and duration of response. Safety is monitored continuously by evaluating vital signs, physical exams, and lab tests. The trial includes close observation for adverse events, with grading according to standard criteria. The total study period includes screening, treatment, and a two-year follow-up to provide detailed information on the drug's effects and safety.
CONDITIONS
Brief Title
Study of Loncastuximab Tesirine in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) Following CAR-T Therapy Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Ability to provide written informed consent
- ECOG performance status between 0 and 2
- Histologically confirmed diagnosis of DLBCL, non-Hodgkin lymphoma, or HGBCL including double/triple-hit lymphomas
- Relapsed or refractory disease after CAR-T therapy with progressive disease or partial/stable response at 3 months
- Measurable disease confirmed by PET-CT, CT, or MRI
- Previous treatment with Loncastuximab Tesirine allowed if in complete or partial response at discontinuation
- Negative pregnancy test for women of childbearing potential within 7 days before first dose
- Use of effective contraception by females from consent until 9 months after last dose
- Use of effective contraception by males with partners of childbearing potential until 6 months after last dose
- Adequate kidney, liver, lung, and heart function
- Adequate hematologic function including neutrophil count, hemoglobin, and platelets
You will not qualify if you...
- Known allergy to Loncastuximab Tesirine or its components
- Pregnant or breastfeeding women
- Active second primary cancers except certain low-risk types
- Active central nervous system involvement including leptomeningeal disease
- Tumor mass larger than 10 cm in diameter
- Positive for HIV, hepatitis B, or hepatitis C requiring treatment
- Significant fluid accumulation causing respiratory distress
- Serious comorbid conditions such as uncontrolled hypertension, unstable angina, severe heart failure, recent heart attack, uncontrolled arrhythmia, poorly controlled diabetes, or severe lung disease
- Active autoimmune diseases affecting the nervous system
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- Recent chemotherapy, radiotherapy, or anticancer treatments within 14 days unless approved
- Planned live vaccine administration after first dose
- Use of experimental drugs within 14 days before first dose
- Unresolved prior treatment toxicities above Grade 1
- Any other condition that may make participation unsafe or unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for assessments including medical history, laboratory tests, imaging studies, and tumor biopsy
Duration - Up to 24 weeks (8 cycles, 3 weeks each)
Participants receive Loncastuximab Tesirine intravenously every 3 weeks for up to 8 cycles, with initial higher doses for the first two cycles followed by lower doses. Each infusion is monitored for safety and tolerability.
8 infusion visits every 3 weeks with close monitoring during and after each infusion; additional visits for clinical evaluations and blood tests
Duration - Up to 2 years
After completing treatment, participants are followed for 2 years with regular imaging and laboratory tests to monitor disease progression and long-term side effects.
Follow-up visits every 3 months for 2 years
Trial Site Locations
Total: 7 locations
1
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, ALESSANDRIA, Italy, 15121
Actively Recruiting
2
Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, BO, Italy, 40138
Actively Recruiting
3
Azienda Sanitaria Ospedaliera Santa Croce e Carle di Cuneo
Cuneo, Cuneo, Italy, 12100
Actively Recruiting
4
Ospedale San Raffaele
Milan, MILANO, Italy, 20132
Actively Recruiting
5
Istituto Nazionale dei Tumori
Milan, MILANO, Italy, 20133
Actively Recruiting
6
Irccs Istituto Clinico Humanitas
Rozzano, MILANO, Italy, 20089
Actively Recruiting
7
AOU Policlinico Umberto I
Roma, RO, Italy, 00161
Actively Recruiting
Research Team
C
Carmelo Carlo-Stella
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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