- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05680038
Penpulimab in Maintenance Therapy in Lymphoma
A Real-world Study of Efficacy and Safety of Penpulimab in Maintenance Therapy in Patients With Post-transplant or Transplant-intolerant Lymphoma
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Lymphoma patients who received transplantation or were intolerant to transplantation achieved remission after previous induction and consolidation therapy. Patients who were intolerant to transplantation here referred to lymphoma patients ≥60 years old or < 60 years old and recommended for transplantation by the guidelines;
- Age ≥18 years old;
- ECOG PS< 2 points;
- Life expectancy is more than 3 months;
- Patients were allowed to receive radiotherapy, but the last radiotherapy was given more than 7 days before the initial study drug administration;
- Normal liver and kidney function, specific for direct bilirubin in serum, serum indirect bilirubin and/or cereal third transaminase, aspertate aminotransferase, serum creatinine 2 or less normal limit, creatinine clearance or ≥60 mL/min.
- Normal bone marrow function, specific defined as absolute neutrophil count (ANC) acuity ≥1.0*10^9 / L, platelet ≥50 *10^9/L and ≥70 g/L or higher hemoglobin;
- Women of childbearing age who used contraception or had a negative pregnancy test before enrollment, and who used contraception during the test period and within 8 weeks of the last drug administration; For men who were methodically contracepted or surgically sterilized during the trial period and 8 weeks after the last dose;
- The subjects voluntarily joined the study and signed the informed consent with good compliance and follow-up.
Exclusion Criteria:
1. Pregnant or lactating women;
2. Patients with a history of autoimmune diseases or syndromes requiring systemic use of steroid immunosuppressants, such as pituitaritis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.;
3. The patient had received systemic glucocorticoids (prednisone > 20mg/ day) therapy (excluding nasal spray, inhaled or other topical corticosteroids) or any other form of immunosuppressive therapy;
4. Uncontrolled heart disease, including unstable angina, acute myocardial infarction 6 months before randomization, congestive heart failure (NYHA) with a grade III or IV heart function; Or left ventricular ejection fraction < 50%;
5. Known allergy to test drug ingredients;
6. Patients receiving organ transplants;
7. Has been diagnosed with or is undergoing treatment for a malignancy other than lymphoma, except for:
had received treatment for the purpose of cure, and had no malignancies with known active disease for ≥5 years prior to enrollment;
Well-treated basal cell carcinoma of the skin with no signs of disease (except melanoma);
Well-treated carcinoma in situ of the cervix with no signs of disease.
8. Patients with grade 3 or above neurotoxic reactions in the two weeks prior to treatment;
9. Severely infected persons;
10. Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or the evaluation of the study results;
11. Those who were considered unsuitable for inclusion by the researchers.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the rates of PFS in 2-years
Time Frame: 24 months
|
the rates of PFS in 2-years
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the rates of OS in 2-years
Time Frame: 24 months
|
the rates of OS in 2-years
|
24 months
|
CR
Time Frame: 24 months
|
CR
|
24 months
|
the rate of CR converted from PR
Time Frame: 24 months
|
the rate of CR converted from PR
|
24 months
|
Number of participants with treatment-related Adverse Events and Serious Adverse Events as assessed by NCI-CTC 5.0
Time Frame: 24 months
|
AE and serious adverse events (SAEs) were observed and graded according to NCI-CTC version 5.0
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Penp-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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