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New treatment option for Follicular Lymphoma
Official title Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
ClinicalTrials.gov ID: NCT04998669
What this study is testing
What is Loncastuximab tesirine?
Loncastuximab tesirine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for follicular lymphoma.
Also referred to as ADCT-402.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men and women ≥ 18 years of age.
- Patients must have histologic confirmation of Follicular Lymphoma (FL) (grade 1, 2 and 3A). Note: Participants who have received previous...
- Patients with relapsed or refractory FL previously treated with ≥1 line of systemic therapy having ≥ 1 Groupe d'Etude des Lymphomes (GELF) criteria...
- Baseline FDG-PET/CT scans must demonstrate positive lesions compatible with CT defined anatomical tumor sites. Patients should have at least one...
- Patient should have ≥ 1 Groupe d'Etude des Lymphomes (GELF) criteria for treatment initiation).
You likely can't join if
- FL grade 3B or transformed FL.
- [Removed]
- ≥ 6 lines of systemic immunochemotherapy for treatment of FL.
- Patients with clinically significant pleural effusions and/or ascites requiring drainage or associated with shortness of breath.
- Patients receiving any other investigational agents.
- Patients with known central nervous system involvement of lymphoma.
See the full eligibility criteria
- Men and women ≥ 18 years of age.
- 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...
- 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...
- 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.
- 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
- Progression or relapse within 24 months of frontline treatment in patients previously treated with ≥1 line of systemic therapy; or
- Second FL relapse/progression after ≥1 line of systemic therapy. These patients will be eligible independently of GELF criteria and POD24.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy of greater than 6 weeks.
- 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).
- FL grade 3B or transformed FL.
- [Removed]
- ≥ 6 lines of systemic immunochemotherapy for treatment of FL.
- Patients with clinically significant pleural effusions and/or ascites requiring drainage or associated with shortness of breath.
- Patients receiving any other investigational agents.
- Patients with known central nervous system involvement of lymphoma.
- 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...
- Breastfeeding or pregnant women.
- 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...
- History of Human immunodeficiency virus (HIV) infection. Note: HIV screening test is optional
- Patients with impaired decision-making capacity.
The study team makes the final eligibility decision.
Where it's taking place
- Fort Myers, Florida, United States
- Miami, Florida, United States
- Ann Arbor, Michigan, United States
- New Brunswick, New Jersey, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Myers, Florida, United States; Miami, Florida, United States; Ann Arbor, Michigan, United States; New Brunswick, New Jersey, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.