A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To learn if loncastuximab tesirine (called lonca in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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‣ Eligible subjects will be considered for inclusion in this study if they meet the following criteria:

• Relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphomas and high-grade B-cell lymphoma

• Receive standard of care treatment with an FDA-approved anti-CD19 autologous CAR T-cell product, outside of a clinical trial

• ≥ 18 years of age

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

• Achievement of PR according to Lugano 2014 response criteria 30 days after CAR T-cell therapy

• At least 30 days must have elapsed since CAR T-cell therapy infusion

• No evidence of CD19 expression after CAR T-cell therapy infusion is required for enrolment

• No additional anti-tumoral therapy, with the exclusion of palliative radiotherapy, must have been received after CAR T-cell therapy

• Absolute neutrophil count (ANC) of ≥ 1.0×109/L without growth factor support for 3 days prior to screening assessment.

⁃ Platelet count of ≥ 50×109/L without transfusion for 3 days prior to screening assessment.

⁃ Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min

⁃ Serum alanine transaminase (ALT) or aspartate transaminase (AST) ≤ 2.5 upper limit of normal (ULN)

⁃ Total bilirubin ≤2 mg/dL, except in subjects with Gilbert's syndrome.

⁃ Cardiac ejection fraction ≥ 45% with no evidence of clinically significant pericardial effusion

⁃ Baseline oxygen saturation \> 92% on room air

⁃ No evidence or suspicion of lymphoma actively involving the central nervous system (CNS)

⁃ Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)

⁃ Resolution of any previous CRS and/or ICANS to grade 0.

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Paolo Strati, MD
pstrati@mdanderson.org
(713) 745-1776
Time Frame
Start Date: 2022-09-23
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 30
Treatments
Experimental: Loncastuximab Tesirine
Participants will receive Loncastuximab Tesirine (lonca) by vein.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov