Clinical trial for Lymphoma, B-Cell
Official title Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
ClinicalTrials.gov ID: NCT06792734
What this study is testing
What is BTM-3566?
an investigational oral solution being studied as a potential treatment for relapsed or refractory mature B‑cell lymphomas
Also referred to as BTM-3566 Oral Solution.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will find out what side effects BTM-3566 causes at different doses and how much of the drug stays in the blood. It will also look at whether the drug can slow or stop the cancer from growing.
- Who it's for
- Adults who have mature B‑cell lymphoma that has come back or did not respond to previous treatment.
- What's involved
- Participants will take BTM-3566 for 7 days, then have a 7‑day break, repeating this 14‑day cycle. They will attend regular clinic visits for check‑ups and tests and keep a diary of their dosing and weight.
- Time commitment
- The trial lasts for several cycles of 14 days each, with clinic visits and testing at each cycle.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- is pregnant or breastfeeding
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Charlotte, North Carolina, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlotte, North Carolina, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.