AzTrials
AzTrials

Large B-cell LymphomaPhase 1/2NCT07638787

Pola-R-CHP Plus Sonrotoclax in Untreated BCL2-High/Double-Hit LBCL

A Phase 1/2 study testing Polatuzumab Vedotin, Rituximab and Cyclophosphamide in people with Large B-cell Lymphoma, run by Ruijin Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Large B-cell Lymphoma
What is being tested?
Polatuzumab Vedotin, Rituximab and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
15 Jun 2026to 30 Apr 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 10Show fewer
  • 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).

Who cannot join

  • 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;
Show all 28Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Peng-Peng Xu contact

+862164370045 ext. 610707

pengpeng_xu@126.com

China1 site

  • Ruijin Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Weili Zhao, 008602164370045, zwl_trial@163.com

Other trials in China

About this study

Official title: A Single-Arm, Prospective Study of Pola-R-CHP Plus Sonrotoclax in Patients With Previously Untreated Large B-Cell Lymphoma (LBCL) With High BCL2 Expression / Double-Hit Lymphoma

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.

Being tested
Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone
Keywords
LBCL, BCL2, DHL, Sonrotoclax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polatuzumab VedotinDrug

    Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm

  • RituximabDrug

    Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

  • CyclophosphamideDrug

    Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

  • DoxorubicinDrug

    Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

  • PrednisoneDrug

    Prednisone PO will be administered as per the schedule specified in the respective arm.

  • SonrotoclaxDrug

    Sonrotoclax PO will be administered as per the schedule specified in the respective arm.

Study groups in NCT07638787
Study groupRoleWhat they receive
Sonrotoclax + Pola-R-CHPExperimentalEligible participants will receive sonrotoclax plus Pola-R-CHP. In Phase I, three dose levels of sonrotoclax will be evaluated with a ramp-up schedule in Cycle 1 (Days 4-10), followed by Days 1-10 dosing at the assigned dose in subsequent cycles: 320 mg, 480 mg, and 640 mg QD. Dose escalation uses a standard 3+3 design to determine the MTD of sonrotoclax. The RP2D will be used with Pola-R-CHP in Phase II.
Receives: Drug: Polatuzumab Vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Sonrotoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of sonrotoclax in combination with Pola-R-CHP

    The MTD is defined as the highest dose at which the incidence of dose-limiting toxicity (DLT) is less than 1/3 of patients.

    Measured: From first dose through 21 consecutive calendar days after reaching the target dose (up to 26 days)

  2. Recommended Phase II Dose (RP2D)

    The determined Maximum Tolerated Dose (MTD) and its dosing regimen will serve as the recommended Phase II dose (RP2D) for the combination regimen, unless safety data support the use of a lower dose.

    Measured: At completion of the DLT evaluation period, up to 26 days

  3. Complete response rate

    CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC (separately)

    Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

Secondary outcomes (5)

  1. Objective response rate

    ORR at treatment completion or discontinuation defined as the proportion of participants with CR or partial response (PR) at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC(separately)

    Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

  2. Progression-free survival

    PFS, defined as the time from diagnosis to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator

    Measured: From enrollment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months)

  3. Overall survival

    OS defined as the time from diagnosis to death from any cause

    Measured: up to approximately 3 years

  4. Duration of Response

    The time from the first documentation of a complete response (CR) or partial response (PR) to the first documentation of disease progression (PD), death from any cause, or the last follow-up, whichever occurs first.

    Measured: From enrollment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months)

  5. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v6.0

    Measured: From enrollment to study completion, a maximum of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07638787
Sponsor's protocol ID
SONATA
Status last verified
Jun 2026
First submitted
28 May 2026
Last updated
30 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Polatuzumab Vedotin, Rituximab and Cyclophosphamide in people with Large B-cell Lymphoma, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peng-Peng Xu (+862164370045 ext. 610707, pengpeng_xu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of sonrotoclax in combination with Pola-R-CHP (time frame: From first dose through 21 consecutive calendar days after reaching the target dose (up to 26 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07638787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in