Pola-R-CHP Plus Sonrotoclax in Untreated BCL2-High/Double-Hit LBCL (NCT07638787) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Pola-R-CHP Plus Sonrotoclax in Untreated BCL2-High/Double-Hit LBCL
China40 participantsStarted 2026-06-15
Plain-language summary
This is a Phase I/II study. The Phase I part will evaluate the safety and tolerability of sonrotoclax in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP), using a standard 3+3 dose-escalation design, to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). The Phase II part will assess the efficacy of the combination regimen in patients with previously untreated LBCL with high BCL2 expression or MYC/BCL2 rearrangements.
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:
* Patients with newly diagnosed large B-cell lymphoma confirmed by histopathology, CD20-positive, excluding central nervous system lymphoma;
* Patients aged 18 to 75 years;
* International Prognostic Index score of 2 to 5;
* Patients with high BCL-2 expression or double-hit lymphoma characteristics;
* No prior anti-tumor treatment of any type;
* Estimated survival time ≥ 6 months;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
* Measurable lesions confirmed by radiological examination, defined as: at least one lymph node lesion with the longest diameter \> 1.5 cm, or at least one extranodal lesion with the longest diameter \> 1.0 cm, and at least two accurately measurable perpendicular diameters;
* Patients or their legal representatives must provide written informed consent before conducting any study-specific examinations or procedures;
* No prior treatment for lymphoma (except glucocorticoids).
Exclusion Criteria:
* Prior solid organ transplantation or stem cell transplantation;
* Complicated with uncontrolled coagulation disorders, connective tissue diseases, severe infectious diseases, etc.;
* Suspected active or latent tuberculosis (confirmed by a positive interferon-gamma release assay);
* Any of the following abnormal laboratory test values (unless these abnormalities are all caused by the underlying lymphoma):
* Neutrophils \< 1.0×10⁹/L;
* Platelets \< 75×10⁹/L;
* Serum AST and ALT ≥ 2.5× upper limit of normal (ULN);
…
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.
What they're measuring
1
Maximum tolerated dose (MTD) of sonrotoclax in combination with Pola-R-CHP
Timeframe: From first dose through 21 consecutive calendar days after reaching the target dose (up to 26 days)
2
Recommended Phase II Dose (RP2D)
Timeframe: At completion of the DLT evaluation period, up to 26 days
3
Complete response rate
Timeframe: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]