Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
Purpose
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
Condition
- Lymphoma, B-Cell
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- must be age ≥18 years - must have a diagnosis of relapsed or refractory mature B cell lymphoma - must have measurable disease per response evaluation criteria in lymphoma (Lugano classification) - must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 - must have a predicted life expectancy of ≥3 months - must agree to use adequate birth control throughout their participation and for 90 days following the last dose of BTM-3566
Exclusion Criteria
- has primary CNS lymphoma - has ongoing toxicities from prior anti-cancer treatment > Grade 1 - has symptomatic or uncontrolled neurologic disease (brain metastases, leptomeningeal disease, or spinal cord compression) not definitively treated with surgery or radiation - has received any anti-cancer therapy (including radiation of curative intent) <28 days prior to administration of BTM-3566 - has current second malignancy at other sites (exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation). - is pregnant or breastfeeding
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BTM-3566 Treatment |
BTM-3566 Oral Solution |
|
Recruiting Locations
Charlotte, North Carolina 28204
Houston, Texas 77030
Luhua M Wang, MD
713-792-2121
More Details
- Status
- Recruiting
- Sponsor
- Bantam Pharmaceuticals
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.