Penpulimab Plus R2-GemOx Regimen in Relapsed or Refractory DLBCL

March 3, 2022 updated by: The First Affiliated Hospital with Nanjing Medical University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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.
Other Names:
  • Rituximab
  • Gemcitabine
  • Oxaliplatin
  • lenalidomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: 6 weeks after the last dose of the combination therapy (each cycle is 14 days)
Complete response rate after treated by penpulimab and R2-GemOx
6 weeks after the last dose of the combination therapy (each cycle is 14 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 2 years
from date of inclusion to date of death from any cause
2 years
Progression-free survival（PFS）
Time Frame: 2 years
from date of inclusion to date of progression, relapse, or death from any cause
2 years
Rate of grade 3 or 4 treatment related adverse effect
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
All the adverse events of the patients related will be assessed and graded by NCI CTCAE v 5.0
Up to 30 days after the last cycle of per-protocol treatment and 90 days after last dose of anti-PD-1 antibody

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2022

Primary Completion (Anticipated)

January 15, 2024

Study Completion (Anticipated)

February 15, 2026

Study Registration Dates

First Submitted

December 23, 2021

First Submitted That Met QC Criteria

December 23, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 7, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-SR-545

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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