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Penpulimab Plus R2-GemOx Regimen in Relapsed or Refractory DLBCL

Primary Purpose

Lymphoma, Large B-Cell, Diffuse, Neoplasms by Histologic Type

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First affiliated Hospital of AnHui Medical Universtiy
  • ChangZhou First People's Hospital
  • Hematological Department, People's Hospital of Jiangsu Province
  • The First Affiliated Hospital Of Nantong University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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;

Outcomes

Primary Outcome Measures

Complete response rate
Complete response rate after treated by penpulimab and R2-GemOx

Secondary Outcome Measures

Overall Survival (OS)
from date of inclusion to date of death from any cause
Progression-free survival（PFS）
from date of inclusion to date of progression, relapse, or death from any cause
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

Full Information

First Posted
December 23, 2021
Last Updated
March 3, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05186558
Brief Title
Penpulimab Plus R2-GemOx Regimen in Relapsed or Refractory DLBCL
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2022 (Anticipated)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
February 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse, Neoplasms by Histologic Type

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
penpulimab, lenalidomide, rituximab, gemcitabine and oxaliplatin（Penpulimab-R2-GemOx)）
Arm Type
Experimental
Arm Description
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;
Intervention Type
Drug
Intervention Name(s)
penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin
Other Intervention Name(s)
lenalidomide, Rituximab, Gemcitabine, Oxaliplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete response rate
Description
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 Outcome Measure Information:
Title
Overall Survival (OS)
Description
from date of inclusion to date of death from any cause
Time Frame
2 years
Title
Progression-free survival（PFS）
Description
from date of inclusion to date of progression, relapse, or death from any cause
Time Frame
2 years
Title
Rate of grade 3 or 4 treatment related adverse effect
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Wang, M.D., Ph.D
Phone
86 25 68306034
Email
lilyw7878@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Xu, M.D., Ph.D
Phone
86 25 68306034
Email
xuwei10000@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Xu
Organizational Affiliation
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First affiliated Hospital of AnHui Medical Universtiy
City
Hefei
State/Province
Anhui
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingshu Zeng, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Qingshu Zeng, M.D., Ph.D.
Facility Name
ChangZhou First People's Hospital
City
ChangZhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiying Gu, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Weiying Gu, M.D., Ph.D.
Facility Name
Hematological Department, People's Hospital of Jiangsu Province
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The First Affiliated Hospital Of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Penpulimab Plus R2-GemOx Regimen in Relapsed or Refractory DLBCL

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