Combining Loncastuximab Tesirine and Rituximab for treating relapsed Follicular Lymphoma
Phase 2, Single-arm, Open-label, Study of Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
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 |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | prednisone, Loncastuximab, Rituximab |
| Locations | 5 sites (Fort Myers, Florida and 4 other locations) |
| Trial ID | NCT04998669 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise with similar combination therapies in treating Follicular Lymphoma, indicating potential for success.
Eligibility criteria
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 this trial is running
Fort Myers, Florida and 4 other locations
- Florida Cancer Specialists and Research Institute — Fort Myers, Florida, United States (Not_yet_recruiting)
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.