Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT06792734
Brief Summary:
The goal of this clinical trial is to learn if BMT-3566 can safety be given to adult patients with relapsed or refractory mature b cell lymphomas. It will also learn how well BTM-3566 works to treat relapsed or refractory mature b cell lymphomas. The main questions it aims to answer are:
What are the side effects of BTM-3566 at different doses? What are the levels of BTM-3566 in the blood at different timepoints around dosing? What is the clinical benefit of BTM-3566 in treating cancer (i.e. how well does it slow or stop disease progression)?
Participants will:
Take BTM-3566 in 14-day periods with 7 days of dosing followed by 7 days of no dosing Visit the clinic regularly for checkups and tests Keep a diary of their dosing and weight
Detailed Description:
This is an open label, phase 1 dose escalation trial of BTM-3566 in relapsed/refractory mature b cell lymphomas. Dose escalation will utilize traditional 3+3 methodology to determine the maximum tolerated dose of BTM-3566. Treatment will be given as two-week cycles, with BTM-3566 taken daily during the first week of the cycle, and the second week 'off therapy'. DLT window will be the first two cycles of therapy (days 1 to 28). All enrolled patients will undergo a baseline FDG-PET/CT scan within 3 weeks prior to starting therapy. FDG-PET/CT will be repeated at the start of Cycles 3 and 5 or more frequently as clinically indicated. Beginning at Cycle 5, imaging will be repeated every 3 months (or as clinically indicated) for up to 12 months, and every 6 months thereafter, until disease progression or start of subsequent anti-cancer therapy.
Study:
NCT06792734
Study Brief:
Protocol Section:
NCT06792734