RECRUITING

Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 2, Single-arm, Open-label, Study of Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma

Quick Facts

Study Start:2022-02-11

Study Completion:2030-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04998669

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Study Contact

Juan P Alderuccio, MD

CONTACT

305-243-5995

jalderuccio@med.miami.edu

Principal Investigator

Juan P Alderuccio, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

Florida Cancer Specialists and Research Institute

Fort Myers, Florida, 33916

United States

University of Miami

Miami, Florida, 33136

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

United States

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212

United States

Collaborators and Investigators

Sponsor: Juan P. Alderuccio, MD

Juan P Alderuccio, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-11

Study Completion Date2030-08-01

Study Record Updates

Study Start Date2022-02-11

Study Completion Date2030-08-01

Terms related to this study

Additional Relevant MeSH Terms

Follicular Lymphoma