Experimental lymphoma combo trial halted early – only 5 patients enrolled
NCT ID NCT05498220
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new combination of drugs (polatuzumab vedotin plus standard chemotherapy) for patients with diffuse large B-cell lymphoma that came back or didn't improve after initial treatment. The trial aimed to see if this mix could shrink tumors better than standard therapy. However, the study was stopped early after enrolling only 5 people, so we have very little information about how well it works or its safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Polatuzumab vedotin combined with rituximab, gemcitabine, dexamethasone, and cisplatin (PV-RGDP chemotherapy)
- What this could lead to
- If successful, this combination could improve response rates for patients whose lymphoma returned after initial treatment, potentially leading to better outcomes before or instead of a stem cell transplant.
- What could go wrong
- The trial was terminated early with only 5 participants, so results are very limited. The combination may not be more effective than standard therapy and could have significant side effects from the chemotherapy drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
5 people
The number who actually took part.
- Started
-
Feb 2023
- Finished
-
Oct 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
In order to participate in this study, a subject must meet all of the eligibility criteria outlined below. Inclusion Criteria: 1. Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. 4. Radiologic evidence of active disease within 28 days of starting trial therapy. 5. Only one prior line of therapy. 6. 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. 7. Subjects may be eligible or ineligible for autologous stem cell transplant Exclusion Criteria: 1. 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. 2. 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. 3. Women who are pregnant or breastfeeding or who intend to become pregnant within a year of the last dose of study treatment. 4. 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. 5. Previous exposure to polatuzumab vedotin. 6. History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine. 7. Contraindication to gemcitabine or cisplatin, or dexamethasone or similar corticosteroid. 8. Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction \< 40%, symptomatic coronary artery disease or symptomatic arrhythmias. 9. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation \> 91% on room air.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514, United States
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