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

Who is this study for? Patients with Follicular Lymphoma
What treatments are being studied? Loncastuximab Tesirine+Rituximab
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 completion of the CD19-directed therapy.

• 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.

• 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).

Locations
United States
Florida
Florida Cancer Specialists and Research Institute
NOT_YET_RECRUITING
Fort Myers
University of Miami
RECRUITING
Miami
Michigan
University of Michigan
NOT_YET_RECRUITING
Ann Arbor
New Jersey
Rutgers Cancer Institute of New Jersey
NOT_YET_RECRUITING
New Brunswick
Pennsylvania
Allegheny Health Network
NOT_YET_RECRUITING
Pittsburgh
Contact Information
Primary
Juan P Alderuccio, MD
jalderuccio@med.miami.edu
305-243-5995
Time Frame
Start Date: 2022-02-11
Estimated Completion Date: 2030-08-01
Participants
Target number of participants: 100
Treatments
Experimental: Loncastuximab tesirine + Rituximab
During the 12-week Induction Phase (Cycles 1 to 4), participants will receive loncastuximab tesirine on days 1 of each 3-week cycle for Cycles 1 through 4; and rituximab on days 1, 8, 15 of Cycle 1 and day 1 of Cycle 2.~Maintenance Phase 1 (Cycle 5) is 8 weeks: Participants achieving complete response (CR) or partial response (PR) during the Induction Phase will receive loncastuximab tesirine once every 3-weeks; and rituximab once during week 7 or 8. Participants achieving a response of Stable Disease (SD) or Progressive Disease (PD) will be taken off treatment.~Maintenance Phase 2 (Cycles 6 and 7) is 16 weeks:~* Participants achieving CR during Maintenance Phase 1 receive rituximab once during week 7 or 8 of Cycles 6 and 7.~* Participants achieving PR during Maintenance Phase 1 receive loncastuximab tesirine once every 3-weeks over each 8 week cycle; and rituximab once during week 7 or 8 of Cycles 6 and 7.~* Participants achieving SD or PD will be taken off treatment.
Sponsors
Leads: Juan P. Alderuccio, MD
Collaborators: ADC Therapeutics S.A.

This content was sourced from clinicaltrials.gov