A Study of BEBT-908 in Combination With Chemotherapy in Patients With Previously Untreated Periph… (NCT07676175) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of BEBT-908 in Combination With Chemotherapy in Patients With Previously Untreated Peripheral T-Cell Lymphoma (PTCL)
China120 participantsStarted 2026-07-01
Plain-language summary
The goal of this clinical study is to find the best way to combine the study drug BEBT-908 (ifupinostat hydrochloride for injection) with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for treating previously untreated peripheral T-cell lymphoma, and to find out whether this best combination is better than standard CHOP treatment alone.
The main questions this study will try to answer are:
What percentage of participants will respond well to treatment with BEBT-908 plus CHOP? Is BEBT-908 plus CHOP better than standard CHOP treatment? What medical problems will participants have while receiving this combination treatment?
This study includes an Exploration Phase and an Expansion Phase. The Exploration Phase has 3 cohorts. All participants receive both BEBT-908 and CHOP, but the dosing arrangements differ across cohorts: the dose of BEBT-908 differs, the sequencing of administration differs, and whether participants continue with CHOP or transition to BEBT-908 depends on their tolerability to CHOP. Eligible participants will receive the combination treatment for their assigned cohort. After that, based on the results from all 3 cohorts in the Exploration Phase, one optimal cohort will be selected to proceed into the Expansion Phase. In the Expansion Phase, eligible participants will be randomly assigned (like flipping a coin) in a 1:1 ratio to either the treatment group, receiving the optimal combination regimen identified in the Exploration Phase, or the control group, receiving 6 cycles of CHOP. This study design will help investigators find the best way to combine BEBT-908 and CHOP for treating previously untreated peripheral T-cell lymphoma, and check whether this optimal combination regimen is better than standard CHOP treatment.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants must fully understand the study and voluntarily sign an informed consent form (ICF).
. Age 18 to 75 years (inclusive), either sex.
. Histologically confirmed peripheral T-cell lymphoma (PTCL), including not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) deemed by the investigator to be ineligible for or unable to receive anti-CD30 monoclonal antibody therapy (e.g., brentuximab vedotin) due to economic burden or intolerable toxicity (if ALK-positive, International Prognostic Index \[IPI\] score must be ≥2), subcutaneous panniculitis-like T-cell lymphoma (SPTCL), enteropathy-associated T-cell lymphoma (EATL), hepatosplenic T-cell lymphoma (HSTL), and other T-cell lymphomas deemed appropriate for enrollment by the investigator.
. No prior systemic anti-PTCL therapy.
. Life expectancy \>6 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
. At least one measurable and evaluable tumor lesion (per Lugano 2014 criteria: nodal lesions must have a longest diameter \>1.5 cm; extranodal lesions must have a longest diameter \>1.0 cm).
. At screening, laboratory parameters must meet the following standards, unless the investigator determines the abnormality is due to lymphoma (with no corrective or supportive treatment for the following parameters within 2 weeks prior to assessment):
Exclusion criteria
. History or current diagnosis of immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia, or other primary or secondary hematologic disorders that may affect bone marrow function, other than the primary malignancy.
. Receipt of transfusion, recombinant human thrombopoietin (rhTPO), erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), or similar treatments within 2 weeks prior to the first dose of study drug.
. Active bleeding within 2 months prior to the first dose, or current use of anticoagulant medications (e.g., warfarin, phenprocoumon), or evidence of a clear bleeding tendency as determined by the investigator (e.g., esophageal varices at risk of bleeding, active localized ulcerative lesions, fecal occult blood \>2+), except for bleeding attributed by the investigator to lymphoma itself (e.g., gastrointestinal bleeding caused by gastrointestinal lymphoma).
. Participation in another interventional clinical trial within 3 months prior to the first dose.
. PTCL with involvement of special sites such as testis, breast, or ovary; extranodal natural killer/T-cell lymphoma (ENKTL); cutaneous T-cell lymphoma (except subcutaneous panniculitis-like T-cell lymphoma \[SPTCL\]); or concurrent hemophagocytic lymphohistiocytosis (HLH).
. Receipt of the following treatments within 7 days prior to study entry: drugs known to be strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers, or drugs known to significantly prolong the QT interval.
. Major surgery requiring general anesthesia within 4 weeks prior to enrollment, or surgery requiring local/epidural anesthesia within 2 weeks prior to enrollment with incomplete recovery (excluding bone marrow biopsy or local lymphoid tissue biopsy).
. Active infection requiring systemic treatment (oral or intravenous) within 2 weeks prior to the first dose, or imaging findings suggestive of interstitial lung disease (ILD), pulmonary fibrosis, or pneumonia (infectious or non-infectious) requiring treatment: participants receiving prophylactic antibiotic therapy (e.g., for interstitial pneumonia) are eligible for enrollment; participants with patchy changes from old or previously treated lesions, determined by the investigator to not affect lung function and not require treatment, are eligible for enrollment.