Effects of ChemotherapyPhase 2NCT06468943

Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

A Phase 2 study testing Polatuzumab Vedotin, Zanubrutinib and Rituximab in people with Effects of Chemotherapy and Safety Issues, run by The First Affiliated Hospital of Soochow University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Aim of this study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Effects of Chemotherapy, Safety Issues
What is being tested?: Polatuzumab Vedotin, Zanubrutinib and Rituximab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: 1 Jul 2023to 1 May 2028
Phase: Phase 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed Non-GCB DLBCL with extrinsic involvement；
Measurable disease of at least 15mm(node)/10mm（extranodal）；
ECOG performance status 0-2；
Adequate organ function:Cardiac ejection fraction (EF) ≥ 50%;Creatinine clearance rate (≥30 mL/min) of serum creatinine; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN；
Adequate bone marrow function:Platelet count (≥ 50×10^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10^9/L)
Estimated survival time ≥3 months
Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study.

Who cannot join

Accepted major surgery within 4 weeks before treatment;
Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma;
Previous history of indolent lymphoma;
Prior malignancy (other than DLBCL), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer 、malignant tonsilloma or carcinoma in situ;
History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists;
Requires treatment with a strong/medium CYP3A inducer;

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The previous use of anthracycline-based drugs > 150 mg/m2;
Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease;
HIV infection and/or active hepatitis B or active hepatitis C;
Uncontrolled systemic infection;
Pregnant or breasting-feeding women;
According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions.

Trial locations and contacts

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

China1 site

The First Affiliated Hospital of Soochow University
Suzhou, Nanjing, 215000

Other trials in China

About this study

Official title: Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients in Treatment of Newly Diagnosed Untreated Non-GCB DLBCL With Extranodal Involvement.

Read the detailed description

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. The POLARIX study also observed an benefit in the efficacy of Polatuzumab Vedotin in first-line treatment of DLBCL patients. This study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.

Conditions: Effects of Chemotherapy, Safety Issues
Being tested: Polatuzumab Vedotin, Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin

What participants receive

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

Polatuzumab VedotinDrug
1.8mg/kg/21d（d0） Intravenous infusion
ZanubrutinibDrug
160mg bid PO（d0-d20）
RituximabDrug
375mg/㎡/21d（d0） Intravenous infusion
CyclophosphamideDrug
750mg/㎡/21d（d1） Intravenous infusion
DoxorubicinDrug
50mg/㎡/21d（d1） Intravenous infusion
PrednisoneDrug
100mg PO （d1-d5）/21d

Study groups in NCT06468943
Study group	Role	What they receive
Patients receiving Pola+ZR-CHP treatment	Experimental	Not described Receives: Drug: Polatuzumab Vedotin; Drug: Zanubrutinib; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone

What is being measured

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

Progression-free Survival（PFS）
The time between enrollment and tumor occurrence (in any aspect) progression or (for any reason) death
Measured: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.

Secondary outcomes (5)

Objective Response rate（ORR）
The proportion of patients who achieved complete or partial response in efficacy evaluation at the end of treatment
Measured: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Complete Response（CR）
The proportion of patients who achieved complete response in efficacy evaluation at the end of treatment
Measured: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Duration of Response（DOR）
It refers to the time from the first assessment of a tumor as CR or PR to the second assessment as PD (Progressive Disease) or death from any cause.
Measured: All time in the study
Overall Survival
The time between enrollment to death(for any reason) .
Measured: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Adverse Events(AEs)
All treatment-related adverse events that occur during patient treatment and follow-up.
Measured: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.

Timeline

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

1 Jul 20231 May 2028

First posted21 Jun 2024
Study start1 Jul 2023
Primary completion1 May 2026 (estimated)
Study completion1 May 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Effects of ChemotherapyStudies of the same condition, open and under way.
More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06468943
Sponsor's protocol ID: Pola-ZR-CHP
Status last verified: Apr 2024
First submitted: 27 Apr 2024
Last updated: 21 Jun 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients in Treatment of Newly Diagnosed Untreated Non-GCB DLBCL With Extranodal Involvement.
ClinicalTrials.gov ID: NCT06468943
Acronym / sponsor ID: Pola-ZR-CHP
Conditions: Effects of Chemotherapy, Safety Issues
Phase: Phase 2
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 20 participants (estimated)
Lead sponsor: The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
Study start: 1 Jul 2023 (actual)
Primary completion: 1 May 2026 (estimated)
Study completion: 1 May 2028 (estimated)
First posted: 21 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients receiving Pola+ZR-CHP treatment	Experimental	Drug: Polatuzumab Vedotin, Drug: Zanubrutinib, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Prednisone

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Histologically confirmed Non-GCB DLBCL with extrinsic involvement；
Measurable disease of at least 15mm(node)/10mm（extranodal）；
ECOG performance status 0-2；
Adequate organ function:Cardiac ejection fraction (EF) ≥ 50%;Creatinine clearance rate (≥30 mL/min) of serum creatinine; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN；
Adequate bone marrow function:Platelet count (≥ 50×10^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10^9/L)

Key exclusion criteria (12 listed)

Accepted major surgery within 4 weeks before treatment;
Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma;
Previous history of indolent lymphoma;
Prior malignancy (other than DLBCL), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer 、malignant tonsilloma or carcinoma in situ;
History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Polatuzumab Vedotin1.8mg/kg/21d（d0） Intravenous infusion	Drug	Patients receiving Pola+ZR-CHP treatment
Zanubrutinib160mg bid PO（d0-d20）	Drug	Patients receiving Pola+ZR-CHP treatment
Rituximab375mg/㎡/21d（d0） Intravenous infusion	Drug	Patients receiving Pola+ZR-CHP treatment
Cyclophosphamide750mg/㎡/21d（d1） Intravenous infusion	Drug	Patients receiving Pola+ZR-CHP treatment
Doxorubicin50mg/㎡/21d（d1） Intravenous infusion	Drug	Patients receiving Pola+ZR-CHP treatment
Prednisone100mg PO （d1-d5）/21d	Drug	Patients receiving Pola+ZR-CHP treatment

Primary outcome

Progression-free Survival（PFS）
Time frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
The time between enrollment and tumor occurrence (in any aspect) progression or (for any reason) death

5 secondary outcomes

Objective Response rate（ORR）
Time frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Complete Response（CR）
Time frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Duration of Response（DOR）
Time frame: All time in the study
Overall Survival
Time frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Adverse Events(AEs)
Time frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 21 Jun 2024. 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 phase mean?

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival（PFS） (time frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.). 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 NCT06468943.

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 21 Jun 2024.