Diffuse Large B-cell LymphomaPhase 2NCT05498220
Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma
A Phase 2 study testing Polatuzumab vedotin (PV), Rituximab and Hyaluronidase in people with Diffuse Large B-cell Lymphoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study aimed to evaluate the efficacy of a novel regimen consisting of polatuzumab vedotin in combination with rituximab, gemcitabine, dexamethasone, and cisplatin (PV-RGDP) for the treatment of diffuse large B-cell lymphoma that either came back or did not improve after the treatments (rrDLBCL). 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 (PV), Rituximab and Hyaluronidase
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2023to 3 Oct 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Biopsy proven diffuse large B-cell lymphoma (DLBCL) in the first relapse (biopsy can be from initial diagnosis). The study will allow high-grade B cell lymphoma, but not including Burkitt's lymphoma.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Radiologic evidence of active disease within 28 days of starting trial therapy.
- Only one prior line of therapy.
- Prior cancer treatment must be completed at least 14 days prior to the start of treatment and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or start of treatment.
- Subjects may be eligible or ineligible for autologous stem cell transplant
Who cannot join
- Known severe, active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at study enrollment that may put the subject at undue risk as determined by the investigator.
- Subjective hearing loss interfering with daily activities or evidence of greater than mild hearing loss compared to age appropriate normal on screening audiometry are excluded.
- Women who are pregnant or breastfeeding or who intend to become pregnant within a year of the last dose of study treatment.
- Subjects with a history of prior or concurrent second primary malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study drugs are eligible for enrollment in the trial.
- Previous exposure to polatuzumab vedotin.
- History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine.
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- Contraindication to gemcitabine or cisplatin, or dexamethasone or similar corticosteroid.
- Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction < 40%, symptomatic coronary artery disease or symptomatic arrhythmias.
- Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation > 91% on room air.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
About this study
Official title: A Phase II Trial Evaluating the Efficacy of Polatuzumab Vedotin With Rituximab, Gemcitabine, Dexamethasone, and Cisplatin (PV-RGDP) Chemotherapy for Relapsed or Refractory Diffuse Large B-cell Lymphoma
This study aimed to evaluate the efficacy of a novel regimen consisting of polatuzumab vedotin in combination with rituximab, gemcitabine, dexamethasone, and cisplatin (PV-RGDP) for the treatment of diffuse large B-cell lymphoma that either came back or did not improve after the treatments (rrDLBCL).
This combination has not been approved by the Food and Drug Administration (FDA) for the treatment of rrDLBCL. Salvage therapy (treatment after standard treatment failed) needs to be improved. Rituximab, gemcitabine, dexamethasone, and cisplatin combination is a standard therapy for rrDLBCL and polatuzumab vedotin (PV) is a novel antibody-drug conjugate targeting CD79b. PV has shown efficacy in the setting of rrDLBCL and can improve the response rates of standard salvage therapy.
This study will focus on subjects in the first relapse (one prior regimen) and will include both subjects who are transplant eligible and those who are transplant ineligible.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Polatuzumab vedotin (PV), Rituximab, Hyaluronidase, Gemcitabine, Cisplatin
- Keywords
- Relapsed, refractory, polatuzumab vedotin, rituximab, gemcitabine, cisplatin
- 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 (PV)Drug
1.8 mg/kg, intravenous, at day 1, in every 21 days
RituximabDrug
375 mg/m2 intravenous, at day 1 or day 2, in every 21 days
HyaluronidaseDrug
1,400 mg/23,400 units sub-cutaneous, starts at cycle 2, in every 21 days
GemcitabineDrug
1,000 mg/m2 intravenous at day 1 and 8, in every 21 days
CisplatinDrug
75 mg/m2, intravenous, at day 1, in every 21 days
DexamethasoneDrug
40 mg intravenous at day 1, Per oral days at days 2-4
GCSFDrug
granulocyte-colony stimulating factor (GCSF )
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | The subjects with diffuse large B-cell lymphoma were relapsed or refractory after the first treatment and receiving the study protocol treatment. Receives: Drug: Polatuzumab vedotin (PV); Drug: Rituximab; Drug: Hyaluronidase; Drug: Gemcitabine; Drug: Cisplatin; Drug: Dexamethasone; Drug: GCSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR is defined as the number of subjects who received the study treatment, and achieved complete response (CR) or partial response (PR) by Lugano classification.
Complete Response: Complete metabolic response on Positron emission tomography (PET) image or Target nodes/nodal masses must regress to ≤ 1.5 cm in the largest transverse diameter (LDi) or no extra lymphatic sites of disease on Computerized Tomography (CT).
Partial Response: Score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size on PET and ≥50% decrease in the sum of the products of diameters (SPD) of up to 6 target measurable nodes and extranodal sites on CT.
Measured: Up to 4 months (End of Treatment)
Secondary outcomes (5)
Complete Response Rate (CR)
CR is defined as the number of subjects who received the study treatment, achieved complete response (CR) by the Lugano classification.
Measured: Up to 4 months (End of Treatment)
Progression Free Survival (PFS)
PFS is defined as the time from the start of study treatment until death, during which participants show no disease progression per Lugano criteria Progressive Disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new fluorodeoxyglucose (FDG) -avid foci consistent with lymphoma at the interim or end-of-treatment assessment on PET, or an individual node/lesion must be abnormal with LDi > 1.5 cm, increase by ≥ 50% from the cross product of the shortest axis perpendicular to LDi (SDi) nadir and an increase in LDi or SDi from nadir: 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions > 2 cm.
Measured: Up to 2 years
Overall Survival (OS)
OS is the time from treatment start until death from any cause; participants still alive are censored.
Measured: Up to 2 years
Number of Participants With Adverse Events
The number of participants with adverse events will be listed and tabulated by grade to determine the safety and toxicity.
Adverse Events will be graded according to The National Cancer Institute (NCI) of Common Terminology Criteria for Adverse Events (CTCAE) version 5. The scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Measured: Up to 2 years
Number of Participants With Serious Adverse Events
The number of participants with adverse events (AEs) will be tabulated per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. AEs are reported with specific terms where possible (e.g., bacteremia, kidney infection, sepsis) under each Organ System Class to avoid repetition. Each AE term is graded as follows: Grade 1 (Mild; asymptomatic or mild symptoms, no intervention), Grade 2 (Moderate; minimal intervention, limits instrumental Activities of Daily Living), Grade 3 (Severe; hospitalization or disabling, limits self-care Activities of Daily Living), and Grade 4 (Life-threatening)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start17 Feb 2023
- Primary completion7 Mar 2025
- Study completion3 Oct 2025
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- 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
- Model description
- The study will use a Simon two-stage design. In the first stage 27 evaluable subjects will be recruited. If there are at least 13 (≥ 13) subjects with a partial or complete response after 4 cycles, another 17 subjects will be enrolled and treated in the second stage of the trial, for a total of 44 evaluable subjects.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Christopher Dittus, DO, MPH, Principal investigator, Division of Hematology | Lymphoma Program Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498220
- Sponsor's protocol ID
- LCCC2033
- Status last verified
- Mar 2026
- First submitted
- 9 Aug 2022
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Evaluating the Efficacy of Polatuzumab Vedotin With Rituximab, Gemcitabine, Dexamethasone, and Cisplatin (PV-RGDP) Chemotherapy for Relapsed or Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05498220
- Acronym / sponsor ID
- LCCC2033
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Relapsed, refractory, polatuzumab vedotin, rituximab, gemcitabine, cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Posted 16 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the efficacy of a novel regimen consisting of polatuzumab vedotin in combination with rituximab, gemcitabine, dexamethasone, and cisplatin (PV-RGDP) for the treatment of diffuse large B-cell lymphoma that either came back or did not improve after the treatments (rrDLBCL).
This combination has not been approved by the Food and Drug Administration (FDA) for the treatment of rrDLBCL. Salvage therapy (treatment after standard treatment failed) needs to be improved. Rituximab, gemcitabine, dexamethasone, and cisplatin combination is a standard therapy for rrDLBCL and polatuzumab vedotin (PV) is a novel antibody-drug conjugate targeting CD79b. PV has shown efficacy in the setting of rrDLBCL and can improve the response rates of standard salvage therapy.
This study will focus on subjects in the first relapse (one prior regimen) and will include both subjects who are transplant eligible and those who are transplant ineligible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will use a Simon two-stage design. In the first stage 27 evaluable subjects will be recruited. If there are at least 13 (≥ 13) subjects with a partial or complete response after 4 cycles, another 17 subjects will be enrolled and treated in the second stage of the trial, for a total of 44 evaluable subjects.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Polatuzumab vedotin (PV), Drug: Rituximab, Drug: Hyaluronidase, Drug: Gemcitabine, Drug: Cisplatin, Drug: Dexamethasone, Drug: GCSFThe subjects with diffuse large B-cell lymphoma were relapsed or refractory after the first treatment and receiving the study protocol treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Biopsy proven diffuse large B-cell lymphoma (DLBCL) in the first relapse (biopsy can be from initial diagnosis). The study will allow high-grade B cell lymphoma, but not including Burkitt's lymphoma.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Radiologic evidence of active disease within 28 days of starting trial therapy.
- Only one prior line of therapy.
Key exclusion criteria (9 listed)
- Known severe, active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at study enrollment that may put the subject at undue risk as determined by the investigator.
- Subjective hearing loss interfering with daily activities or evidence of greater than mild hearing loss compared to age appropriate normal on screening audiometry are excluded.
- Women who are pregnant or breastfeeding or who intend to become pregnant within a year of the last dose of study treatment.
- Subjects with a history of prior or concurrent second primary malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study drugs are eligible for enrollment in the trial.
- Previous exposure to polatuzumab vedotin.
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 vedotin (PV)1.8 mg/kg, intravenous, at day 1, in every 21 days | Drug | Single Arm |
| Rituximab375 mg/m2 intravenous, at day 1 or day 2, in every 21 days | Drug | Single Arm |
| Hyaluronidase1,400 mg/23,400 units sub-cutaneous, starts at cycle 2, in every 21 days | Drug | Single Arm |
| Gemcitabine1,000 mg/m2 intravenous at day 1 and 8, in every 21 days | Drug | Single Arm |
| Cisplatin75 mg/m2, intravenous, at day 1, in every 21 days | Drug | Single Arm |
| Dexamethasone40 mg intravenous at day 1, Per oral days at days 2-4 | Drug | Single Arm |
| GCSFgranulocyte-colony stimulating factor (GCSF ) | Drug | Single Arm |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 4 months (End of Treatment)
ORR is defined as the number of subjects who received the study treatment, and achieved complete response (CR) or partial response (PR) by Lugano classification. Complete Response: Complete metabolic response on Positron emission tomography (PET) image or Target nodes/nodal masses must regress to ≤ 1.5 cm in the largest transverse diameter (LDi) or no extra lymphatic sites of disease on Computerized Tomography (CT). Partial Response: Score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size on PET and ≥50% decrease in the sum of the products of diameters (SPD) of up to 6 target measurable nodes and extranodal sites on CT.
5 secondary outcomes
Complete Response Rate (CR)
Time frame: Up to 4 months (End of Treatment)
Progression Free Survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Number of Participants With Adverse Events
Time frame: Up to 2 years
Number of Participants With Serious Adverse Events
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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. This study is not recruiting at the moment.
Christopher Dittus, DO, MPH principal investigator
Division of Hematology | Lymphoma Program Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polatuzumab vedotin (PV), Rituximab and Hyaluronidase in people with Diffuse Large B-cell Lymphoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 16 Apr 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (ORR) (time frame: Up to 4 months (End of Treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.