Loncastuximab Tesirine and Venetoclax for Relapsed/ Refractory Non-Hodgkin Lymphoma

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Paolo Caimi, MD
Study ID
NCT05053659
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Refractory Non-Hodgkin Lymphoma
  • Relapsed Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Loncastuximab tesirine — DRUG
    Loncastuximab tesirine 50 - 150 μg/kg will be administered as a 30 minutes IV infusion on Day 1 of each cycle for 6 cycles. On doses over 100 μg/kg, subsequent dosing (i.e. beyond 100 μg/kg) will be done at 50% of the dose that is administered on the first 2 cycles.
  • Venetoclax — DRUG
    Participants will receive venetoclax at target doses of 400 - 800mg orally on days 1 - 5 of each (21 day) cycle. On cycle 1, venetoclax dose will be escalated to reach the target dose over the course of 5 days for target dose 400mg, 6 days for target dose 600mg and 7 days for target dose 800mg Venetoclax should preferably be given after a meal and on cycle 1 should be preceded by prophylaxis for tumor lysis syndrome (TLS).

Study Details

The purpose of this study is to determine the correct dose and safety of combining two new cancer drugs, loncastuximab tesirine and venetoclax, as a treatment for relapsed or refractory B cell lymphoma.These drugs are used to treat some lymphomas, but have not yet been tested in combination for the treatment of lymphoma. The main goal of this study is to determine the safety of the combination.

Key Dates

Start date
Jun 20, 2022
Status verified
Jun 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Loncastuximab tesirine & venetoclax
    Participants will receive a baseline disease assessment via PET/CT in FDG avid lymphomas; CT scan (chest, abdomen, pelvis; inclusion of neck in selected cases). Bome marrow biopsy in selected cases. Premedication includes: * Allopurinol (to reduce uric acid) 300mg orally daily starting day -1 and continuing at least until day 7 of each cycle. * Dexamethasone (steroid pre-medication) 4mg orally twice daily on day -1, day 1 and day 2 of each cycle. * Adequate oral hydration starting on day -1 or -2, defined as 1 - 2 liters of oral intake of liquids in 24 hours Study treatment to be given every 21 days. * Loncastuximab tesirine (50 - 150 μg/kg) intravenously (IV) on day 1 of each 21-day cycle * Venetoclax (400 - 800 mg) orally, every day on days 1 - 5 of each 21-day cycle. Dose ramp-up on cycle 1 (over days 1 - 5 for target dose 400mg, 1 - 6 for target dose 600mg and 1 - 7 for target dose 800mg

Primary Outcome Measure

Dose limiting toxicities (DLTs) during cycle 1 of loncastuximab tesirine and venetoclax [ Time Frame: Up to Day 21 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44195-

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By research site
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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