New cocktail aims to tackle tough lymphoma
NCT ID NCT07638787
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This early-stage trial tests whether adding sonrotoclax to standard Pola-R-CHP chemotherapy can improve outcomes for people with untreated large B-cell lymphoma that has high BCL2 expression or double-hit features. The study has two parts: first, finding a safe dose of sonrotoclax, then checking how well the combination works in 40 patients aged 18-75.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sonrotoclax combined with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP)
- What this could lead to
- If successful, this combination could offer a more effective first-line treatment for aggressive large B-cell lymphoma with high BCL2 expression or double-hit genetics.
- What could go wrong
- This is an early Phase 1/2 trial with only 40 participants, so safety and effectiveness are not yet proven. The added drug may increase side effects without improving outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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); * Total bilirubin ≥ 1.5×ULN; * Serum creatinine clearance \< 30 mL/min (calculated using the Cockcroft-Gault formula); * Uncontrolled or significant cardiovascular diseases, including but not limited to: * Left ventricular ejection fraction (LVEF) \< 50%; * Primary cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, etc.; * Clinically significant QTc prolongation, with QTc interval \> 470 ms (females) or 480 ms (males), second-degree type II atrioventricular block, or third-degree atrioventricular block; * Current or past history of central nervous system (CNS) diseases, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative diseases. However, participants with a history of stroke who have not had a stroke or transient ischemic attack in the past 2 years and have no residual neurological deficits as judged by the investigator are allowed to participate in the study; * Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol; * Patients infected with human immunodeficiency virus (HIV); * History of other malignant tumors that may affect protocol compliance or interpretation of results: * Participants with a history of cured basal or squamous cell carcinoma of the skin, melanoma, or carcinoma in situ of the cervix at any time before the study are eligible to participate; * Participants with a history of untreated low-grade early-stage prostate cancer (Gleason score ≤ 6, Stage 1 or 2) at any time before the study are eligible to participate; * Participants who received adjuvant endocrine therapy for non-metastatic, hormone receptor-positive breast cancer for ≥ 2 years before enrollment are eligible to participate; * Participants with any other malignant tumor cured by appropriate radical treatment and in remission without treatment for ≥ 2 years before enrollment are eligible to participate; * History of immune-related adverse events following prior immunotherapy drug-related treatment, as follows: known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding onychomycosis) at study enrollment, or major infections within 4 weeks before the start of Cycle 1; * Active hepatitis B virus (HBV) infection (positive result by PCR). For patients with positive HBsAg test results, HBV DNA test is required; if HBV DNA \< 10³ IU/ml, they can be enrolled. If HBsAg test result is negative but HBcAb test is positive (regardless of HBsAb status), HBV DNA test is also required; if HBV DNA \< 10³ IU/ml, they can be enrolled; * Positive hepatitis C test result (serological test for hepatitis C virus \[HCV\] antibody): * Eligibility to participate is only allowed if the PCR test result for HCV RNA is negative in patients with positive HCV antibody; * Participants with a history of progressive multifocal leukoencephalopathy (PML); * Currently pregnant or breastfeeding, or planning to become pregnant during the study or within 12 months after the last dose; * Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
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Other studies related to the condition(s) this trial covers.
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- New combo therapy aims to boost remission in Hard-to-Treat lymphoma
- Engineered immune cells get a boost: new combo therapy targets Hard-to-Treat blood cancers
- New combo aims to boost lymphoma control in older patients