AzTrials
AzTrials

Diffuse Large B Cell LymphomaPhase 2NCT05940051

Prospective Clinical Study of ZPR Regimen in Relapsed/Refractory Diffuse Large B-cell Lymphoma

A Phase 2 study testing Zanubrutinib, Polatuzumab vedotin and Rituximab in people with Diffuse Large B Cell Lymphoma, run by Peng Liu at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR（Zanubrutinib, Polatuzumab vedotin and Rituximab）regimen in the treatment of patients with relapsed and refractory diffuse large B-cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Zanubrutinib, Polatuzumab vedotin and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
20 Jul 2023to 30 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following inclusion criteria to be enrolled in this study:
  • Patients with histopathologically confirmed DLBCL;
  • Relapsed or refractory disease, defined as
  • Disease relapse occurred after reaching disease remission (including complete response [CR] and partial response [PR]) at the end of the last treatment
  • Maintain stable disease (SD) or progressive disease (PD) at the end of the last treatment
  • The age of patients ≥ 18 years old and ≤ 80 years old;
Show all 15Show fewer
  • The ECOG score was 0-2;
  • Good organ function;
  • Measurable lesions detected by radiological imaging were defined as the longest diameter of at least 1 lymph node lesion > 1.5 cm, or the longest diameter of at least 1 extranodal lesion > 1.0 cm, and at least 2 vertical diameters that could be accurately measured;
  • Previously received ≥ 1 systemic therapy for lymphoma;
  • Participants who relapse after autologous stem cell transplantation may be included, provided that the transplantation treatment has been more than 6 months from the screening;
  • Fresh tumor biopsies or recent tumor tissue samples must be provided (within 2 years after study entry [signed informed consent]);
  • Fertile women must agree to use efficient contraceptive measures throughout the study and at least 90 days after the last dose of study drug. The effective forms of birth control are defined as abstinence, hysterectomy, bilateral oophorectomy without menstrual bleeding for up to 6 months, intrauterine contraception, hormonal methods such as contraceptive injection, oral contraceptives; Fertile men must undergo sterilization vasectomy or use condoms, while their female partners use the above efficient contraceptive measures;
  • Life expectancy ≥ 6 months;
  • Sign written informed consent.

Who cannot join

  • Patients with any of the following conditions cannot be enrolled in this study:
  • Patients with primary central nervous system lymphoma;
  • Patients with previous exposure to BTK inhibitors;
  • Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc;
  • Currently clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, congestive heart failure, any grade 3 or 4 heart disease defined by the New York Heart Association functional classification, or history of myocardial infarction within 6 months after screening. The left ventricular ejection fraction measured by echocardiography was < 50%;
  • Abnormal laboratory indicators at screening (unless caused by lymphoma):
Show all 20Show fewer
  • ANC<1.5×10^9/l, PLT<80×10^9/l
  • Coagulation function: INR greater than 1.5 times the upper limit of normal value; Pt and APTT were greater than 1.5 times the upper limit of normal
  • Liver function: ALT or ast was 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal
  • Renal function: creatinine was 1.5 times higher than the upper limit of normal, creatinine clearance rate was < 60 ml/min (estimated according to Cockcroft Gault formula)
  • HIV-infected persons;
  • HCV active infection;
  • HBsAg positive patients need to be HBV DNA negative before enrollment; In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA testing is still required. If the result is positive, antiviral treatment is required, and HBV DNA is required to be negative before enrollment;
  • Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study, including psychiatric patients or other patients who are known or suspected to be unable to fully comply with the study protocol;
  • Known allergy to test drug;
  • Inability to swallow capsules or suffering from diseases that seriously affect gastrointestinal function, such as malabsorption syndrome, gastrectomy or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction;
  • Pregnant or lactating women;
  • Corticosteroids (dose equivalent to prednisone > 20 mg/ day) were previously given for antitumor purposes within 7 days, and chemotherapy, targeted therapy, or radiotherapy were previously received within 3 weeks, or antibody-based therapy was received within 3 weeks, or traditional Chinese medicine anticancer therapy was performed within 4 weeks;
  • Major surgery was performed within 4 weeks after screening;
  • Sustained treatment with potent and moderate CYP3A inhibitors or CYP3A inducers is needed. Patients could not be enrolled if they had taken potent and moderate CYP3A inhibitors or CYP3A inducers within 7 days before the first administration of study drugs (or had taken these drugs for no more than 5 half-lives).

Trial locations and contacts

1 site in 1 country.

Peng Liu, Ph.D contact

+862164041990 ext. 2025

liu.peng@zs-hospital.sh.cn

Yian Zhang, Ph.D contact

+862164041990 ext. 613010

zhang.yi_an@zs-hospital.sh.cn

China1 site, 1 recruiting

  • Zhongshan Hospital，Fudan University

    Shanghai, Shanghai Municipality, 200032

    Peng Liu, Ph.D, +862164041990 ext. 2025, liu.peng@zs-hospital.sh.cn

    Yian Zhang, Ph.D, +862164041990 ext. 613010, zhang.yi_an@zs-hospital.sh.cn

    Recruiting

Other trials in China

About this study

Official title: Prospective Single-arm, Single-center Clinical Study of Zanubrutinib, Polatuzumab Vedotin and Rituximab (ZPR) Regimen in Relapsed/Refractory Patients With Diffuse Large B-cell Lymphoma

This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR（Zanubrutinib, Polatuzumab vedotin and Rituximab）regimen in the treatment of patients with relapsed and refractory diffuse large B-cell lymphoma.

Read the detailed description

This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR（Zanubrutinib, Polatuzumab vedotin and Rituximab）regimen in the treatment of patients with relapsed and refractory diffuse large B-cell lymphoma.

  • Primary objective: use ORR to evaluate the effectiveness of ZPR in treating R/R DLBCL patients
  • Secondary objective: Evaluate the safety of ZPR treatment for R/R DLBCL patients
  • The subjects received 6 cycles of ZPR regimen, one cycle every 21 days. Then Zanubrutinib alone will continue to be used until Zanubrutinib has been used for 1 year or the disease progresses or the adverse effects, death, withdrawal of informed consent or study termination.

Zanubrutinib（Z）160 mg bid po Day 1-21; Polatuzumab vedotin（P）1.8 mg/kg ivgtt D1; Rituximab（R）375 mg/m2 ivgtt D1.

Being tested
Zanubrutinib, Polatuzumab vedotin and Rituximab
Keywords
Diffuse large B-cell lymphoma, Relapsed, Refractory, Polatuzumab, Zanubrutinib, Rituximab, Efficacy, Safty
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Recurrence

What participants receive

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

  • Zanubrutinib, Polatuzumab vedotin and RituximabDrug

    Zanubrutinib（Z）160 mg bid po Day 1-21; Polatuzumab vedotin（P）1.8 mg/kg ivgtt D1; Rituximab（R）375 mg/m2 ivgtt D1

Study groups in NCT05940051
Study groupRoleWhat they receive
R/R Diffuse Large B-cell LymphomaExperimentalNot described
Receives: Drug: Zanubrutinib, Polatuzumab vedotin and Rituximab

What is being measured

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

  1. ORR at the end of the 6th treatment cycle

    the proportion of participants who have achieved complete or partial remission determined by the researcher.

    Measured: about six months from the start of ZPR

Secondary outcomes (3)

  1. CRR at the end of the 6th treatment cycle

    the proportion of subjects evaluated by researchers to obtain CR.

    Measured: about six months from the start of ZPR

  2. Proportion of patients who have achieved 2-year PFS

    Defined as the proportion of participants with a time of ≥ 2 years from the start of treatment to the first recording of disease progression or death, based on the investigator's assessment of the first occurrence

    Measured: 2 years, from the start of treatment to the first recording of disease progression or death, based on the investigator's assessment of the first occurrence

  3. Safety evaluation

    incidence and severity of adverse events (AE) and Serious adverse event (SAE) during the study

    Measured: between the first administration of the study drug and 30 days after discontinuation, or during the progression of the disease or the initiation of new anticancer treatment, whichever came first

Timeline

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

  1. First posted11 Jul 2023
  2. Study start20 Jul 2023 (estimated)
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion30 Dec 2025 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05940051
Sponsor's protocol ID
SHZS-DLBCL002
Status last verified
Jul 2023
First submitted
19 Jun 2023
Last updated
11 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data of all patients will be stored in the self-owned EDC system of Zhongshan Hospital Affiliated to Fudan University, and the research results will be published in the form of research papers.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zanubrutinib, Polatuzumab vedotin and Rituximab in people with Diffuse Large B Cell Lymphoma, run by Peng Liu 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 15 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. 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?

Results are not available in the source record.

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

Contact Peng Liu, Ph.D (+862164041990 ext. 2025, liu.peng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR at the end of the 6th treatment cycle (time frame: about six months from the start of ZPR). 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 NCT05940051.

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 11 Jul 2023.

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