Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
- Conditions
- Follicular Lymphoma
- Registration Number
- NCT04998669
- Lead Sponsor
- Juan P. Alderuccio, MD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria:<br><br> 1. Men and women = 18 years of age.<br><br> 2. Patients must have histologic confirmation of Follicular Lymphoma (FL) (grade 1, 2<br> and 3A). Note: Participants who have received previous CD19-directed therapy must<br> have a biopsy which shows CD19 expression after completion of the CD19-directed<br> therapy.<br><br> 3. Patients with relapsed or refractory FL previously treated with =1 line of systemic<br> therapy having = 1 Groupe d'Etude des Lymphomes (GELF) criteria for therapy, or<br> Progression of Diseases within 24 months (POD24), or second relapse.<br><br> 4. Baseline FDG-PET/CT scans must demonstrate positive lesions compatible with CT<br> defined anatomical tumor sites. Patients should have at least one measurable site of<br> disease per Lugano classification.<br><br> 5. Patient should have = 1 Groupe d'Etude des Lymphomes (GELF) criteria for treatment<br> initiation).<br><br> - Involvement of =3 nodal sites, each with diameter of =3 cm<br><br> - Any nodal or extranodal tumor mass with a diameter of =7 cm<br><br> - B symptoms (fever = 38 degrees Celsius of unclear etiology, night sweats,<br> weight loss > 10% within the prior 6 months).<br><br> - Risk of local compressive symptoms that may result in organ compromise<br><br> - Splenomegaly or splenic lesion without splenomegaly<br><br> - Leukopenia (leukocytes < 1000/mm3)<br><br> - Leukemia (> 5.000 lymphoma cells/mm3)<br><br> - Bone lesions detected on FDG-PET/CT; or<br><br> 6. Progression or relapse within 24 months of frontline treatment in patients<br> previously treated with =1 line of systemic therapy; or<br><br> 7. Second FL relapse/progression after =1 line of systemic therapy. These patients will<br> be eligible independently of GELF criteria and POD24.<br><br> 8. Eastern Cooperative Oncology Group (ECOG) performance status = 2.<br><br> 9. Life expectancy of greater than 6 weeks.<br><br> 10. Patients must have normal organ and marrow function as defined below,<br><br> - Absolute neutrophil count =1000/mm3 (unless due to lymphoma involvement of the<br> bone marrow or spleen).<br><br> - Platelets =100,000/mm3 or = 60,000/mm3 in case of bone marrow involvement by<br> lymphoma.<br><br> - Hemoglobin = 10 g/dL or =8 g/dL in case of bone marrow involvement by lymphoma.<br><br> - Total bilirubin < 1.5 x within normal institutional limits (unless due to<br> lymphoma involvement of liver or a known history of Gilbert's disease).<br><br> - Gamma-Glutamyl Transpeptidase (GGT)/Aspartate Aminotransferase<br> (AST)/(SGOT)/Alanine Aminotransferase (ALT)(SGPT) = 2.5 × institutional upper<br> limit of normal.<br><br> - Creatinine within normal institutional limits, or creatinine clearance =30<br> ml/min/1.7m^2 for patients with creatinine levels above institutional normal<br> (unless due to lymphoma).<br><br>Exclusion Criteria:<br><br> 1. FL grade 3B or transformed FL.<br><br> 2. [Removed]<br><br> 3. = 6 lines of systemic immunochemotherapy for treatment of FL.<br><br> 4. Patients with clinically significant pleural effusions and/or ascites requiring<br> drainage or associated with shortness of breath.<br><br> 5. Patients receiving any other investigational agents.<br><br> 6. Patients with known central nervous system involvement of lymphoma.<br><br> 7. Uncontrolled intercurrent illness such as: history of Myocardial Infarction (MI) in<br> the last 6 months, congestive heart failure New York Heart Association (NYHA) Class<br> III-IV, uncontrolled or symptomatic arrhythmia, stroke in last 6 months, liver<br> cirrhosis, and autoimmune disorder requiring immunosuppression or long-term<br> corticosteroids (>10 mg daily prednisone equivalent).<br><br> 8. Breastfeeding or pregnant women.<br><br> 9. Serologic status reflecting active hepatitis B or C infection. Patients that are<br> positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or<br> hepatitis C antibody will need a negative polymerase chain reaction (PCR) prior to<br> enrollment. (PCR positive patients will be excluded.) Hepatitis C antibody positive<br> patients are eligible if PCR is negative. Hepatitis B core antibody (+) patients<br> without evidence of HBsAg or Hep B PCR (+) are eligible with appropriate Hepatitis B<br> reactivation prophylaxis.<br><br> 10. History of Human immunodeficiency virus (HIV) infection. Note: HIV screening test is<br> optional<br><br> 11. Patients with impaired decision-making capacity.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants achieving Complete Response (CR)
- Secondary Outcome Measures
Name Time Method Number of participants achieving CR or PR;Incidence of Treatment-Related Adverse Events;Progression-free Survival (PFS);Overall Survival (OS)