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Diffuse Large B-Cell LymphomaPhase 2NCT07001540

Evaluation of the Efficacy and Safety of Polatuzumab Vedotin Combined With Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as Salvage Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients Ineligible for Autologous Transplantation

A Phase 2 study testing Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R- GemOx) in people with Diffuse Large B-Cell Lymphoma, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, multicenter, single-arm clinical study designed to evaluate the efficacy and safety of Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as salvage therapy for relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) patients ineligible for autologous… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R- GemOx)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteChina
Study dates
8 May 2025to 15 Nov 2027
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

  • -
  • Participants must meet all of the following criteria to participate in the study:
  • Age ≥18 years old;
  • ineligible for autologous transplantation;
  • Sign the Informed Consent Form (ICF);
  • CD79b-positive DLBCL confirmed by pathology (including transformed DLBCL, PMBL, HGBCL);
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  • Patients must have received adequate first-line treatment and only first-line treatment, with
  • Anti-CD20 monoclonal antibodies (unless the investigator determines that the tumor is CD20-negative)
  • Chemotherapy regimens containing anthracyclines
  • Recurrent or refractory diseases after first-line immunochemotherapy:
  • Refractory disease is defined as not having a complete response to first-line therapy (except for patients who are intolerant to first-line therapy)
  • Recurrent disease is defined as disease recurrence after complete response to first-line treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, with an expected survival of more than 12 weeks.
  • Have at least one measurable two-dimensional lesion identified by clinical examination, CT scan or MRI: ① lymph node >1.5cm; ② Other non-lymph node lesions ≥1.0cm;
  • The main tissues and organs function well:
  • Hematological function: absolute granulocyte count ≥ 1,000/mm3, platelet count ≥ 75,000/mm3; Liver function: ALT/AST < 3 times upper limit of normal (ULN) and total bilirubin ≤1.5× upper limit of normal (ULN) (< 5 times ULN in patients with Gilbert syndrome, cholestasis due to hilar compression adenopathy, biliary obstruction due to liver involvement or lymphoma); Renal function: creatinine clearance > 30 mL/min, creatinine ≤1.5× upper limit of normal (ULN) Lung function: indoor oxygen saturation ≥95%; Cardiac function: no obvious cardiac insufficiency or cardiovascular disease; 10. Fertile patients must be willing to use highly effective contraception during the study period and for 120 days after the last dose of treatment.

Who cannot join

  • -
  • Subjects who meet any of the following criteria are not eligible to participate in this study:
  • Subjects with any factor that may affect their ability to comply with the protocol, as determined by the investigator, including uncontrollable medical, psychological, family, social, or geographical conditions, or those unwilling or unable to follow the procedures required by the study protocol.
  • Known human immunodeficiency virus (HIV) infection or immunoassay positive；
  • Viral infections that cannot be controlled by antiviral drugs, such as active herpes virus infection, acute or chronic active hepatitis B, acute or chronic active hepatitis C, etc. (Note: chronic HBV carriers or inactive HBsAg positive subjects with HBV-DNA lower than the lower limit of detection can be enrolled, requiring clinical evaluation and preventive antiviral therapy if appropriate; HCV antibody negative can be enrolled, HCV antibody positive patients need to test HCV-RNA, if negative can be enrolled)
  • Patients with uncontrolled lymphomas with CNS infiltration (CNS disease diagnosed at initial diagnosis is allowed, provided complete remission of CNS disease is achieved and maintained and no CNS disease is present at recurrence);
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  • Patients who have previously received oxaliplatin or gemcitabine treatment;
  • Pregnant or lactating patients;
  • Other concurrent serious illness or medical condition that would prevent 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.

Wenhao Zhang, M.D contact

021-64175590

ZWHL98@foxmail.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200231

    Wenhao Zhang, M.D, 021-64175590, ZWHL98@foxmail.com

    Recruiting

Other trials in China

About this study

Official title: Evaluation of the Efficacy and Safety of Polatuzumab Vedotin Combined With Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as Salvage Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients Ineligible for Autologous Transplantation: A Prospective, Multicenter, Single-Arm Clinical Study

This is a prospective, multicenter, single-arm clinical study designed to evaluate the efficacy and safety of Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as salvage therapy for relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) patients ineligible for autologous transplantation.

Read the detailed description

This prospective, multicenter, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of Pola-R-GemOx in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are unsuitable for autologous transplantation. The study aims to enroll 130 patients, all of whom will initially receive three cycles of Pola-R-GemOx. Subsequent treatment decisions will be based on therapeutic efficacy and transplant assessment. ① Patients achieving complete response (CR) or partial response (PR) after three cycles will proceed with an additional three cycles. Those achieving CR following six cycles will conclude treatment, while all other patients will transition to subsequent-line therapy. ② Patients who do not achieve CR or PR after three cycles will discontinue the regimen and proceed directly to subsequent-line therapy. The primary endpoint of the trial is the investigator-assessed objective response rate (ORR). Secondary endpoints include other efficacy measures, such as complete response rate (CR), event-free survival (EFS), 24-month progression-free survival (PFS) rate, overall survival (OS), and safety outcomes. Additionally, exploratory analyses will be conducted to identify potential predictors of clinical efficacy and safety.

Being tested
Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R- GemOx)
Keywords
Polatuzumab vedotin combined with rituximab, gemcitabine and oxaliplatin (Pola-R-GemOx), Recurrent/refractory diffuse large B-cell lymphoma that is not suitable for autologous migration, Prospective, multicenter, single-armed
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.

  • Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R- GemOx)Drug

    Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx)

Study groups in NCT07001540
Study groupRoleWhat they receive
Treatment groupExperimentalSecond-line salvage therapy for relapsed/refractory DLBCL patients ineligible for autologous transplantation.
Receives: Drug: Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R- GemOx)

What is being measured

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

  1. Invetigator-assessed Objective Response Rate (ORR)

    Defined as the proportion of all analyzable subjects achieving complete response (CR) and partial response (PR) after study initiation.

    Measured: Assessed up to 3 years

Secondary outcomes (5)

  1. The CR rate assessed by the investigator

    Defined as the proportion of all analyzable subjects achieving complete response (CR) after study initiation.

    Measured: Assessed up to 3 years

  2. Event-free survival (EFS)

    Defined as the time from the start of treatment to disease progression/recurrence, death from any cause, or the start of next line lymphoma therapy (NALT); Patients who had not experienced an event at the time of analysis were excluded from the most recent disease assessment date.

    Measured: Assessed up to 3 years

  3. 24-month progression-free survival (PFS) rate

    PFS is defined as the time between the start of treatment and first recording to disease progression or death; Patients who had not experienced an event at the time of analysis were excluded from the most recent disease assessment date.

    Measured: Assessed up to 24 months

  4. Overall survival time (OS)

    Defined as the time from the start of treatment until death from any cause; Patients who had not experienced an event at the time of analysis were deleted on the date the patient was last known to be alive.

    Measured: Assessed up to 15 years

  5. Security

    The incidence of adverse events (AES), defined as all adverse events that occurred after a patient received the investigatory treatment regimen; The incidence of treatment-related AES was defined as the incidence of AEs associated with salvage therapy, transplantation, and consolidation therapy considered by the investigator after a patient received the investigational treatment.

    Measured: Assessed up to 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 posted3 Jun 2025
  2. Study start8 May 2025
  3. Primary completion15 Nov 2027 (estimated)
  4. Study completion15 Nov 2027 (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
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07001540
Sponsor's protocol ID
Pola-R-Gemox
Status last verified
Jun 2025
First submitted
25 May 2025
Last updated
19 Jun 2025
Results posted
No
Data monitoring committee
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 2 study testing Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R- GemOx) in people with Diffuse Large B-Cell Lymphoma, run by Fudan University 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 16 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 19 Jun 2025. 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?

Contact Wenhao Zhang, M.D (021-64175590, ZWHL98@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invetigator-assessed Objective Response Rate (ORR) (time frame: Assessed up to 3 years). 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 NCT07001540.

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 19 Jun 2025.

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