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Trial Title:
Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients With Treatment-naive Non-GCB DLBCL
NCT ID:
NCT06530511
Condition:
Diffuse Large B Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Rituximab
Polatuzumab vedotin
Conditions: Keywords:
elderly
frail
PRO
Non-GCB
DLBCL
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Polatuzumab vedotin
Description:
Polatuzumab: 1.8 mg/kg, IV Drip infusion, D1;
Arm group label:
PRO
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Rituximab: 375 mg/m2, IV Drip infusion, D1
Arm group label:
PRO
Intervention type:
Drug
Intervention name:
Orelabrutinib
Description:
Orelabrutinib: 150 mg/time, qd, po, D1-21
Arm group label:
PRO
Summary:
This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly
patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and
safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this
population. The primary endpoint is CR rate after induction therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with histopathologically confirmed DLBCL;
- The sGA evaluation result of octogenarians or 60-79 years old is unfit or f RA
il;
- Non-germinal center (Non-GCB) type;
- ECOG performance status score of 0-3 points; ⑤ No previous treatment
for Lymphoma (unless glucocorticoid); 6 Radiographic Investigation to
measurable disease, defined as the longest diameter with at least one
Lymph node disorder > 1.5 cm, or at least one extranodal lesion > 1.0
cm in the longest diameter; ⑦ Adequate organ function;
- Life expectancy ≥ 12 weeks; ⑨ Signed written informed consent.
Exclusion Criteria:
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases,
Coagulopathy diseases, autoimmune diseases and severe Immunization diseases, etc.;
- Laboratory abnormalities at screening (unless caused by Lymphoma) A) ANC < 1.5
x 109/L, PLT < 80 x 109/L b） Coagulation: INR greater than 1.5 x upper limit of
normal; PT and APTT greater than 1.5 x upper limit of normal c） Liver function:
ALT or AST 2 times higher than upper limit of normal, AKP and Bilirubin 1.5
times higher than upper limit of normal d） Renal function: Creatinine high 1.5
times the upper limit of normal, Creatinine clearance < 60 mL/min (estimated by
C OC kcroft-Gault formula); ③ HIV Infection;
- HbsAg positive patients should be HBV DNA negative before enrollment; in
addition, if the patients are HBsAg negative but HBcAb positive
(regardless of HBsAb status), HBV DNA detection is still required; if the
results are positive, antiviral therapy is required, and HBV DNA negative
before enrollment;
- Requires continuous treatment with strong and moderate CYP3A
inhibitors or CYP3A Induction agents. Patients who have taken strong
and moderate CYP3A inhibitors or CYP3A Induction agents (or have
taken these agents within 5 half-lives) within 7 days prior to the
first dose of study drug should not be enrolled; ⑥ Inability to
swallow capsules or suffering from diseases that seriously affect
gastrointestinal function, such as Syndrome malabsorption, gastric or
Small intestinal resection, symptomatic Inflammatory bowel disease or
partial or complete Intestinal obstruction; ⑦ Other concurrent and
uncontrolled medical conditions that, in the opinion of the
investigators, would affect the patients' participation in the study,
including patients with Psychosis or other patients known or
suspected to be unable to fully comply with the study protocol.
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Country:
China
Contact:
Last name:
Huayuan Zhu, PhD
Start date:
August 1, 2024
Completion date:
August 1, 2026
Lead sponsor:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Source:
Affiliated Hospital of Nantong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06530511
