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Loncastuximab Tesirine and Rituximab for Follicular Lymphoma

This study is looking at a combination of two drugs, Loncastuximab Tesirine and Rituximab, for people with follicular lymphoma that has come back or not responded to previous treatments. The main goal is to see if this combination can lead to a complete response (meaning the cancer is no longer detectable). You might be able to join if you are at least 18 years old and have follicular lymphoma. If you've had certain prior treatments, a biopsy showing CD19 expression is needed. The study aims to enroll 100 participants to understand how effective this treatment combination is.

Study design
This is an interventional study with a planned enrollment of 100 participants. The phase of the study is not specified.
What's involved
Loncastuximab Tesirine will be given intravenously (through a vein) on Day 1 of a 3-week cycle during Cycles 1 and 2 at 150 μg/Kg, then at 75 μg/Kg. Rituximab will be given intravenously or subcutaneously (under the skin) during Cycles 1 and 2.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures complete response at 12 weeks.

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NCT04998669

Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Juan P. Alderuccio, MD
~100 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:Loncastuximab tesirineRituximab

At a glance

Recruiting sites
3 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants achieving Complete Response (CR)
Measured over 12 weeks

Conditions

Follicular Lymphoma

Explore related trials

Follicular Lymphoma

Where it's being run

5 sites across 4 states
Florida2
Michigan1
New Jersey1
Pennsylvania1

Study leadership

  • Juan P Alderuccio, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Juan P Alderuccio, MD
[email protected]
305-243-5995
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Involvement of ≥3 nodal sites, each with diameter of ≥3 cm
Any nodal or extranodal tumor mass with a diameter of ≥7 cm
B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss \> 10% within the prior 6 months).
Risk of local compressive symptoms that may result in organ compromise
Splenomegaly or splenic lesion without splenomegaly
Leukopenia (leukocytes \< 1000/mm3)
Leukemia (\> 5.000 lymphoma cells/mm3)
Bone lesions detected on FDG-PET/CT; or 6. Progression or relapse within 24 months of frontline treatment in patients previously treated with ≥1 line of systemic therapy; or 7. Second FL relapse/progression after ≥1 line of systemic therapy. These patients will be eligible independently of GELF criteria and POD24. 8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 9. Life expectancy of greater than 6 weeks. 10. Patients must have normal organ and marrow function as defined below,
Absolute neutrophil count ≥1000/mm3 (unless due to lymphoma involvement of the bone marrow or spleen).
Platelets ≥100,000/mm3 or ≥ 60,000/mm3 in case of bone marrow involvement by lymphoma.
Hemoglobin ≥ 10 g/dL or ≥8 g/dL in case of bone marrow involvement by lymphoma.
Total bilirubin \< 1.5 x within normal institutional limits (unless due to lymphoma involvement of liver or a known history of Gilbert's disease).
Gamma-Glutamyl Transpeptidase (GGT)/Aspartate Aminotransferase (AST)/(SGOT)/Alanine Aminotransferase (ALT)(SGPT) ≤ 2.5 × institutional upper limit of normal.
Creatinine within normal institutional limits, or creatinine clearance ≥30 ml/min/1.7m\^2 for patients with creatinine levels above institutional normal (unless due to lymphoma).

What this trial measures

  • Number of participants achieving Complete Response (CR)12 weeks

    Complete Response rate will be reported as the number of participants achieving complete response (CR) to study therapy. Response to therapy will be assessed using Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) (FDG-PET)/ Computerized Tomography (CT) following Lugano 2014 criteria by week 12 of treatment.