Combining Loncastuximab Tesirine and Rituximab for treating relapsed Follicular Lymphoma
Official title: Phase 2, Single-arm, Open-label, Study of Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
Run by University of Miami · NCT04998669 · Data updated 2026-11-12
This study is testing if combining two treatments, Loncastuximab Tesirine and Rituximab, can help people with relapsed Follicular Lymphoma feel better compared to current options.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | prednisone, Loncastuximab, Rituximab |
| Locations | 5 sites (Fort Myers, Florida and 4 other locations) |
| Status | Recruiting |
| Started | February 11, 2022 |
| Main results expected | August 1, 2027 |
| Study ends | August 1, 2030 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT04998669 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with relapsed or refractory Follicular Lymphoma who have undergone at least one prior systemic therapy.
✕Probably not a fit
Patients who have not been diagnosed with Follicular Lymphoma or those who have not experienced relapse or refractory disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of Loncastuximab Tesirine in combination with Rituximab for patients suffering from relapsed or refractory Follicular Lymphoma. The study aims to determine if this combination therapy can achieve a higher complete response rate compared to existing treatments. Eligible participants must have confirmed Follicular Lymphoma and meet specific criteria related to their disease progression and previous treatments. The trial will assess the safety and efficacy of the treatment regimen through various clinical evaluations.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with difficult-to-treat Follicular Lymphoma.
How similar studies have gone: Other studies have shown promise with similar combination therapies in treating Follicular Lymphoma, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
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).
* 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).
Exclusion Criteria:
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.
9. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody will need a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.) Hepatitis C antibody positive patients are eligible if PCR is negative. Hepatitis B core antibody (+) patients without evidence of HBsAg or Hep B PCR (+) are eligible with appropriate Hepatitis B reactivation prophylaxis.
10. History of Human immunodeficiency virus (HIV) infection. Note: HIV screening test is optional
11. Patients with impaired decision-making capacity.
Where it's running
-
University of Miami
Miami, Florida, United States Recruiting -
University of Michigan
Ann Arbor, Michigan, United States Recruiting -
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States Recruiting -
Florida Cancer Specialists and Research Institute
Fort Myers, Florida, United States Not yet recruiting -
Allegheny Health Network
Pittsburgh, Pennsylvania, United States Not yet recruiting
Study contacts
- Principal investigator: Juan P Alderuccio, MD — University of Miami
- Study coordinator: Juan P Alderuccio, MD
- Email: jalderuccio@med.miami.edu
- Phone: 305-243-5995
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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MK-1045 and Rituximab in Follicular Lymphoma
This study tests whether adding MK-1045 to rituximab can help people with follicular lymphoma after standard therapy.
-
First-line therapy with Loncastuximab Tesirine and Rituximab for PTLD after transplant
This trial tests if loncastuximab tesirine plus rituximab can help adults with post-transplant lymphoproliferative disorder after a transplant.
-
Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL
This trial tests whether giving allogeneic NK cells with Rituximab, Tafasitamab, and IL-2 can help people with relapsed or refractory B-cell non-Hodgkin lymphoma who have tried at least two prior therapies.
-
Combining Loncastuximab and Roflumilast with R-CHOP for High-Risk Diffuse Large B-cell Lymphoma
This study is testing a new treatment plan that combines loncastuximab and roflumilast with standard chemotherapy to see if it helps people with high-risk diffuse large B-cell lymphoma do better.
-
Golcadomide plus rituximab versus investigator's choice for relapsed or refractory follicular lymphoma
This trial tests whether combining golcadomide with rituximab works better than standard investigator‑selected treatments for adults with relapsed or refractory follicular lymphoma who have had at least one prior systemic therapy.
-
Tafasitamab with lenalidomide and rituximab for newly diagnosed follicular and marginal zone lymphoma
This trial will test whether adding tafasitamab to rituximab and lenalidomide is safe and helps people newly diagnosed with follicular lymphoma or marginal zone lymphoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.