AzTrials
AzTrials

Lymphoma, Large B-Cell, DiffusePhase 2NCT05186558

Penpulimab Plus R2-GemOx Regimen in Relapsed or Refractory DLBCL

A Phase 2 study testing penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin in people with Lymphoma, Large B-Cell, Diffuse and Neoplasms by Histologic Type, run by The First Affiliated Hospital with Nanjing Medical University at 4 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 study evaluates the efficacy and safety of penpulimab plus lenalidomide, rituximab, gemcitabine and oxaliplatin (R2-GemOx) in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL). All patients will receive six cycles of penpulimab plus R2-GemOx. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
4 sitesChina
Study dates
15 May 2022to 15 Feb 2026
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

  • Pathologically confirmed CD20+ diffuse large B-cell lymphoma
  • Age range from 18 to 80 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • Expectation survival time over 3 months;
  • According to Lugano 2014, at least one measurable nodular lesion with a length of greater than 15 mm, or extranodal lesion greater than 10 mm, lesion on FDG-PET scan demonstrates uptake);
  • Diffuse large B-cell lymphoma patients failed to first-line rituximab based chemotherapy including anthracycline or anthracycline
Show all 9Show fewer
  • Patients are allowed to receive palliative radiotherapy, but the last time radiotherapy cannot be within 7 days before the first study drug administration;
  • Adequate organ function
  • Willingness to provide written informed consent.

Who cannot join

  • Pregnant or lactating women;
  • Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months;
  • Patients with autoimmune diseases requiring treatment or with a history of syndrome requiring systemic use of steroid immunosuppressive agents, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc;
  • Patients received systemic glucocorticoid therapy (excluding nasal spray, inhaled or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first administration;
  • Uncontrolled heart disease, including unstable angina pectoris, acute myocardial infarction 6 months before randomization, congestive heart failure (NYHA) heart function grade III or IV; or left ventricular ejection fraction of the heart <50% ；
  • Patients are allergic to penpulimab, lenalidomide, CD20 monoclonal antibody and GemOx regimen
Show all 12Show fewer
  • Patients who have had previous organ transplants (except autologous hematopoietic stem cell transplants);
  • History of other malignancy within the past 5 years (except for 1. basal cell carcinoma of the skin and 2. carcinoma in situ of the cervix and 3. patients who had received treatment for the purpose of cure and had not developed a malignant tumor with a known active disease in the previous 5 years);
  • Those who have had neurotoxicity of grade 3 or above within two weeks before treatment;
  • Severe or uncontrolled infections;
  • Patients with drug abuse, medical, psychological or social conditions that may interfere with the study results or the assessment of the study results;
  • Patients are unsuitable for the enrollment according to investigator's judgement.

Trial locations and contacts

4 sites in 1 country.

Li Wang, M.D., Ph.D contact

86 25 68306034

lilyw7878@163.com

Wei Xu, M.D., Ph.D contact

86 25 68306034

xuwei10000@hotmail.com

China4 sites

  • ChangZhou First People's Hospital

    Changzhou, Jiangsu, 213003

    Weiying Gu, M.D., Ph.D.

    Weiying Gu, M.D., Ph.D.

  • The First affiliated Hospital of AnHui Medical Universtiy

    Hefei, Anhui

    Qingshu Zeng, M.D., Ph.D.

    Qingshu Zeng, M.D., Ph.D.

  • Hematological Department, People's Hospital of Jiangsu Province

    Nanjing, Jiangsu, 210029

  • The First Affiliated Hospital Of Nantong University

    Nantong, Jiangsu, 226000

Other trials in China

About this study

Official title: A Multi-center, Single-arm, Open Label Study to Assess the Efficacy and Safety of Anti-PD-1 Antibody (Penpulimab) Plus Lenalidomide, Rituximab, Gemcitabine and Oxaliplatin (R2-GemOx) in Patients With Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLBCL)

This study evaluates the efficacy and safety of penpulimab plus lenalidomide, rituximab, gemcitabine and oxaliplatin (R2-GemOx) in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL). All patients will receive six cycles of penpulimab plus R2-GemOx. Afterwards, 1) patients who achieve complete response (CR)/unconfirmed (CRu)/partial response (PR) assessed by positron emission tomography/computedtomography (PET-CT) and are eligible for autologous stem cell transplantation (ASCT) will undergo ASCT. 2) Patients who achieve CR/CRu/PR assessed by PET-CT and are not eligible for ASCT will directly receive penpulimab and lenalidomide as maintenance treatment, penpulimab for a maximum of 6 months, lenalidomide monotherapy for 18 months. 3) Patients achieved stable disease (SD) or progression disease (PD) assessed by PET-CT will withdraw from this study and receive proper treatment based on investigator's decision.

Being tested
penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Neoplasms by Histologic Type

What participants receive

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

  • penpulimab, lenalidomide, Rituximab, Gemcitabine, OxaliplatinDrug

    Also called lenalidomide, Rituximab, Gemcitabine, Oxaliplatin

    Patients receive penpulimab+R2-GemOx two weeks for a cycle, detailed as follows:

    Combination therapy Anti-PD-1 antibody (penpulimab): Fixed dose of 200 mg every 2 weeks, d0, intravenous drip (without pretreatment), for 6 cycles.

    R2-GemOx: lenalidomide 10 mg，d1-7; Rituximab 375mg/m2, d0; Gemcitabine 1000mg, d1; Oxaliplatin 100mg/m2, d1; every 2 weeks for a cycle, 6 cycles as protocol specified.

    Maintenance treatment:

    Combination of two drugs:

    • Anti-PD-1 antibody (penpulimab): Fixed dose of 200 mg every 2 weeks, d0, intravenous drip (without pretreatment), , for 6 months
    • lenalidomide: 10 mg, po, for 18 months.
Study groups in NCT05186558
Study groupRoleWhat they receive
penpulimab, lenalidomide, rituximab, gemcitabine and oxaliplatin（Penpulimab-R2-GemOx)）Experimentalpenpulimab: 200 mg q2w, iv, drip R2-GemOx: lenalidomide 10 mg，po; Rituximab 375mg/m2, iv, drip; Gemcitabine 1000mg, po; Oxaliplatin 100mg/m2, iv, drip;
Receives: Drug: penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin

What is being measured

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

  1. Complete response rate

    Complete response rate after treated by penpulimab and R2-GemOx

    Measured: 6 weeks after the last dose of the combination therapy (each cycle is 14 days)

Secondary outcomes (3)

  1. Overall Survival (OS)

    from date of inclusion to date of death from any cause

    Measured: 2 years

  2. Progression-free survival（PFS）

    from date of inclusion to date of progression, relapse, or death from any cause

    Measured: 2 years

  3. Rate of grade 3 or 4 treatment related adverse effect

    All the adverse events of the patients related will be assessed and graded by NCI CTCAE v 5.0

    Measured: Up to 30 days after the last cycle of per-protocol treatment and 90 days after last dose of anti-PD-1 antibody

Timeline

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

  1. First posted11 Jan 2022
  2. Study start15 May 2022 (estimated)
  3. Primary completion15 Jan 2024 (estimated)
  4. Study completion15 Feb 2026 (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
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05186558
Sponsor's protocol ID
2021-SR-545
Status last verified
Mar 2022
First submitted
23 Dec 2021
Last updated
7 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liang JH, Xing TY, Gu WY, Yin H, Zeng QS, Du KX, Sibusiso L, Wu JZ, Li Y, Wang F, Gao R, Li JY, Shen HR, Wang L, Xu W. Penpulimab in combination with lenalidomide and R-GemOx regimen (R2-GemOx-PD1i) in relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm, phase 2 trial. BMC Med. 2026 Feb 9;24(1):156. doi: 10.1186/s12916-026-04679-1.

    PubMed 41656201

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin in people with Lymphoma, Large B-Cell, Diffuse and Neoplasms by Histologic Type, run by The First Affiliated Hospital with Nanjing Medical University at 4 sites 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 9 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: status not confirmed, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 Li Wang, M.D., Ph.D (86 25 68306034, lilyw7878@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (time frame: 6 weeks after the last dose of the combination therapy (each cycle is 14 days)). 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 NCT05186558, which also lists 1 linked publication.

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 7 Mar 2022.

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