Loncastuximab Tesirine in Combination With Chemotherapy Prior to Stem Cell Transplant for the Tre… (NCT05228249) | Clinical Trial Compass
WithdrawnPhase 1
Loncastuximab Tesirine in Combination With Chemotherapy Prior to Stem Cell Transplant for the Treatment of Recurrent or Refractory Diffuse Large B-Cell Lymphoma
Stopped: PI left institution and funding sponsor closed study. Study did not open to accrual, and no participants were enrolled.
United States0Started 2023-04
Plain-language summary
This phase I trial studies the side effects and best dose of loncastuximab tesirine in combination with carmustine, etoposide, cytarabine, and melphalan (BEAM) chemotherapy regimen in treating patients with diffuse large B-cell lymphoma that has come back (recurrent) or has not responded to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as carmustine, etoposide, cytarabine, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with loncastuximab tesirine may kill more cancer cells.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PART 1: Subjects must have a histologically confirmed diagnosis of diffuse large B-cell lymphoma including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma (with MYC and BCL-2 and/or BCL-6 gene rearrangement), and DLBCL arising from follicular lymphoma
* PART 1: Subjects must be eligible for high-dose therapy (BEAM conditioning chemotherapy) and autologous stem cell transplant, as determined by transplant center
* PART 1: Subjects must have chemosensitive disease as defined radiographically (positron emission tomography \[PET\]/computed tomography \[CT\] and/or diagnostic CT) by at least a partial response (PR) to their last cycle of salvage therapy, within 60 days of enrollment
* PART 1: Subjects must be \>= 18 years of age
* PART 1: Eastern Cooperative Oncology Group (ECOG) score =\< 2 or Karnofsky score \>= 60%
* PART 1: Creatinine clearance (CrCl) \> 40 mL/min by Cockcroft-Gault formula or serum creatinine =\< 2.0 mg/dL
* PART 1: Total bilirubin =\< 1.5 x the upper limit of normal (ULN) unless isolated hyperbilirubinemia attributed to Gilbert's syndrome; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN
* PART 1: Adequate pulmonary function, defined as lung carbon monoxide diffusing capability test (DLCO) (corrected or uncorrected for hemoglobin per institutional standards), forced expiratory volume in 1 (FEV1), forced vital capacity (FV…
What they're measuring
1
Incidence of dose-limiting toxicity (Part 1)
Timeframe: Up to 30 days
2
Incidence of toxicity requiring dose delay or modification (Part 2)