NCT04998669 Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
| NCT ID | NCT04998669 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Juan P. Alderuccio, MD |
| Condition | Follicular Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-02-11 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2022-02-11 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Juan P Alderuccio, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT04998669 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Follicular Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04998669 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04998669 currently recruiting?
Yes, NCT04998669 is actively recruiting participants. Contact the research team at jalderuccio@med.miami.edu for enrollment information.
Where is the NCT04998669 trial being conducted?
This trial is being conducted at Fort Myers, United States, Miami, United States, Ann Arbor, United States, New Brunswick, United States and 1 additional location.
Who is sponsoring the NCT04998669 clinical trial?
NCT04998669 is sponsored by Juan P. Alderuccio, MD. The principal investigator is Juan P Alderuccio, MD at University of Miami. The trial plans to enroll 100 participants.