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Not yet recruitingNCT05186558Updated Mar 7, 2022

Penpulimab Plus R2-GemOx Regimen in Relapsed or Refractory DLBCL

A Phase 2 interventional study of penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin in Lymphoma, Large B-Cell, Diffuse and Neoplasms by Histologic Type, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting at 4 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-07.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Lymphoma, Large B-Cell, Diffuse
  • Neoplasms by Histologic Type
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 54 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    penpulimab, lenalidomide, rituximab, gemcitabine and oxaliplatin(Penpulimab-R2-GemOx))

    penpulimab: 200 mg q2w, iv, drip R2-GemOx: lenalidomide 10 mg,po; Rituximab 375mg/m2, iv, drip; Gemcitabine 1000mg, po; Oxaliplatin 100mg/m2, iv, drip;

    Drug: penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin

Interventions

  • Drugpenpulimab, 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.

    Also known as: lenalidomide, Rituximab, Gemcitabine, Oxaliplatin

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What researchers measure

Primary outcomes

  1. Complete response rate

    Complete response rate after treated by penpulimab and R2-GemOx

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

Secondary outcomes

  1. Overall Survival (OS)

    from date of inclusion to date of death from any cause

    Time frame: 2 years

  2. Progression-free survival(PFS)

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

    Time frame: 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

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

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Study locations

4 sites
  • The First affiliated Hospital of AnHui Medical Universtiy
    Hefei, Anhui, China
    • Qingshu Zeng, M.D., Ph.D. · Contact
    • Qingshu Zeng, M.D., Ph.D. · Principal investigator
  • ChangZhou First People's Hospital
    ChangZhou, Jiangsu 213003, China
    • Weiying Gu, M.D., Ph.D. · Contact
    • Weiying Gu, M.D., Ph.D. · Principal investigator
  • Hematological Department, People's Hospital of Jiangsu Province
    Nanjing, Jiangsu 210029, China
  • The First Affiliated Hospital Of Nantong University
    Nantong, Jiangsu 226000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05186558
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Jan 11, 2022
Start date
May 15, 2022 (estimated)
Primary completion
Jan 15, 2024 (estimated)
Completion
Feb 15, 2026 (estimated)
Last update
Mar 7, 2022

Study contacts

Li Wang, M.D., Ph.D
Contact
lilyw7878@163.com
86 25 68306034
Wei Xu, M.D., Ph.D
Contact
xuwei10000@hotmail.com
86 25 68306034
Wei Xu
principal investigator · The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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