RecruitingFollicular Lymphoma
Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
The purpose of this research is to see if Loncastuximab Tesirine in combination with Rituximab will result in higher complete response rate when given to treat follicular lymphoma.
Sponsor: Juan P. Alderuccio, MD
You may qualify if…
- ✓ 1. Men and women ≥ 18 years of age.
- ✓ 2. Patients must have histologic confirmation of Follicular Lymphoma (FL) (grade 1, 2 and 3A). Note: Participants who have received previous CD19-directed therapy must have a biopsy which shows CD19 expression after completion of the CD19-directed therapy.
- ✓ 3. Patients with relapsed or refractory FL previously treated with ≥1 line of systemic therapy having ≥ 1 Groupe d'Etude des Lymphomes (GELF) criteria for therapy, or Progression of Diseases within 24 months (POD24), or second relapse.
- ✓ 4. Baseline FDG-PET/CT scans must demonstrate positive lesions compatible with CT defined anatomical tumor sites. Patients should have at least one measurable site of disease per Lugano classification.
- ✓ 5. Patient should have ≥ 1 Groupe d'Etude des Lymphomes (GELF) criteria for treatment initiation).
- ✓ 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).
You may not qualify if…
- ✕ 1. FL grade 3B or transformed FL.
- ✕ 2. \[Removed\]
- ✕ 3. ≥ 6 lines of systemic immunochemotherapy for treatment of FL.
- ✕ 4. Patients with clinically significant pleural effusions and/or ascites requiring drainage or associated with shortness of breath.
- ✕ 5. Patients receiving any other investigational agents.
- ✕ 6. Patients with known central nervous system involvement of lymphoma.
- ✕ 7. Uncontrolled intercurrent illness such as: history of Myocardial Infarction (MI) in the last 6 months, congestive heart failure New York Heart Association (NYHA) Class III-IV, uncontrolled or symptomatic arrhythmia, stroke in last 6 months, liver cirrhosis, and autoimmune disorder requiring immunosuppression or long-term corticosteroids (\>10 mg daily prednisone equivalent).
- ✕ 8. Breastfeeding or pregnant women.
Where it's recruiting
Source: ClinicalTrials.gov · NCT04998669 · last updated 2026-03-23