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Trial Title:
Penpulimab in Maintenance Therapy in Lymphoma
NCT ID:
NCT05680038
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Penpulimab
Description:
Penpulimab is a modified PD1 inhibitor, which innovated the use of IgG1 subtype. On the
basis of ensuring the stability of the antibody, it eliminated ADCC, ADCP, CDC and other
effects that were not conducive to the efficacy of T cells and reduced the effect of ADCR
by modifying the Fc segment
Summary:
Panpulimab is a modified PD1 inhibitor, which innovated the use of IgG1 subtype. On the
basis of ensuring the stability of the antibody, it eliminated ADCC, ADCP, CDC and other
effects that were not conducive to the efficacy of T cells and reduced the effect of ADCR
by modifying the Fc segment. There have been no studies on the safety and efficacy of
Panpulimab in maintenance therapy after transplantation or in patients with
transplant-intolerant lymphoma. The maintenance treatment of Panpulimab in our center has
been preliminarily explored in clinic, and the results show good efficacy and safety.
Therefore, based on the mechanism of PD1 monoclonal antibody maintenance therapy in
lymphoma and the results of related clinical studies, this study proposed a regimen of
peamprilizumab maintenance therapy for post-transplant or transplant intolerant lymphoma
patients in real world studies, with the main purpose of observing the efficacy and
safety of this regimen in lymphoma patients.
Detailed description:
After the completion of first-line induction and consolidation therapy, the lymphoma
patients who received transplantation or were intolerant to transplantation were treated
with Panpulimab monotherapy, 200 mg, once every three weeks, and were evaluated after six
months of maintenance therapy. The patients who were evaluated as CR were excluded from
the group, and the patients who did not reach CR were continued to take medication until
CR. Review every 3 months from the first year of maintenance treatment and every 6 months
from the second year to the fifth year.
Criteria for eligibility:
Study pop:
Patients with lymphoma after transplantation or intolerant to transplantation
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. 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;
2. Age ≥18 years old;
3. ECOG PS< 2 points;
4. Life expectancy is more than 3 months;
5. Patients were allowed to receive radiotherapy, but the last radiotherapy was given
more than 7 days before the initial study drug administration;
6. 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.
7. 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;
8. 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;
9. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 1, 2023
Completion date:
March 2025
Lead sponsor:
Agency:
WEI XU
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05680038