Trial Title:
The Efficacy and Safety of Pola-ZR2 Versus ZR2 in the Treatment of Old Patients With de Novo Diffuse Large B-cell Lymphoma
NCT ID:
NCT06522555
Condition:
Diffuse Large B-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Rituximab
Lenalidomide
Zanubrutinib
Polatuzumab vedotin
Conditions: Keywords:
diffuse large B-cell lymphoma
polatuzumab vedotin
zanubrutinib
lenalidomide
rituximab
old patients
unfit
frail
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
polatuzumab vedotin, zanubrutinib, rituximab and lenalidomide
Description:
Drug: Polatuzumab vedotin, Zanubrutinib, Lenalidomide and Rituximab (Pola-ZR2)
Induction therapy:
The Pola-ZR2 regimen will be given from day 1 of each cycle of treatment. Each cycle will
last for 21 days. Participants will receive a total of 6 cycles.
Dosage:
Polatuzumab vedotin 1.8 mg/kg, day 2 on the 1st cycle and day 1 on the 2nd to 6th cycle;
Zanubrutinib, 160 mg bid, po, day 1-21; Lenalidomide, 25 mg qd, po, day 2-11; Rituximab,
375 mg/m2, ivgtt, day 1.
Maintenance therapy:
Patients who receive complete response or partial response after induction therapy will
receive lenalidomide 25 mg qd po during 1-10 days in every 21 days for 2 years.
Arm group label:
Pola-ZR2
Intervention type:
Drug
Intervention name:
zanubrutinib, rituximab and lenalidomide
Description:
Drug: Zanubrutinib, Lenalidomide and Rituximab (ZR2)
Induction therapy:
The ZR2 regimen will be given from day 1 of each cycle of treatment. Each cycle will last
for 21 days. Participants will receive a total of 6 cycles.
Dosage:
Zanubrutinib, 160 mg bid, po, day 1-21; Lenalidomide, 25 mg qd, po, day 2-11; Rituximab,
375 mg/m2, ivgtt, day 1.
Maintenance therapy:
Patients who receive complete response or partial response after induction therapy will
receive lenalidomide 25 mg qd po during 1-10 days in every 21 days for 2 years.
Arm group label:
ZR2
Summary:
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the
efficacy and safety of Pola-ZR2 (polatuzumab vedotin, zanubrutinib, rituximab and
lenalidomide) versus ZR2 (zanubrutinib, rituximab and lenalidomide) in the treatment of
old patients with de novo diffuse large B-cell lymphoma
Detailed description:
This study will evaluate the efficacy and safety of Pola-ZR2 versus ZR2 in the treatment
of elderly de novo diffuse large B-cell lymphoma patients. Subjects will be randomly
assigned 1:1 to Pola-ZR2 or ZR2 regimen. The stratification will be performed according
to international prognostic index (2-3 / 4-5).
Patients in Pola-ZR2 group will receive 6 cycles of polatuzumab vedotin 1.8 mg/kg, day 2
on the 1st cycle and day 1 on the 2nd to 6th cycle, zanubrutinib 160mg bid, day 1-21,
orally, lenalidomide 25mg qd, day 2-11, orally, rituximab 375mg/m², day 1, intravenously,
every 21 days. Patients in ZR2 group will receive 6 cycles of zanubrutinib 160mg bid, day
1-21, orally, lenalidomide 25mg qd, day 2-11, orally, rituximab 375mg/m², day 1,
intravenously, every 21 days.
Patients who receive complete response or partial response after induction therapy will
receive lenalidomide 25 mg qd po during 1-10 days in every 21 days for 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients must satisfy all of the following criteria to be enrolled in the study:
- Histologically-confirmed diffuse large B-cell lymphoma (without central nervous
system involvement)
- Aged ≥ 80 years old or aged 70-79 with comprehensive geriatric assessment stratified
as unfit or frail
- International prognostic index score 2 to 5
- At least 1 measurable site of disease (defined as lymph nodes with the long
diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer
than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical
diameters)
- Able to swallow capsules
- Life expectancy of at least 3 months determined by researchers
- The patient or his or her legal representative must provide written informed consent
prior to any special examination or procedure for the research.
- Anti-lymphoma drugs have not been used before (except glucocorticoids)
Exclusion Criteria:
Presence of any of the following criteria will exclude a patient from enrollment:
- Uncontrolled blood clotting disorders, connective tissue diseases, serious
infectious diseases and other diseases
- Laboratory measures meet the following criteria at screening (unless caused by
lymphoma):
Neutrophils<1.5×10^9/L Platelets<80×10^9/L ALT or AST is 2 times higher than the upper
limits of normal (ULN), serum bilirubin are 1.5 times higher than the ULN.
Creatinine is 1.5 times higher than the ULN or eGFR is lower than 40ml/min/1.73m^2
(according to Cockcroft-Gault Equation or MDRD Equation).
- uncontrollable or significant cardiovascular diseases, including but not limited to:
Left ventricular ejection fraction<50% Cardiomyopathy, such as dilated
cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy QTc
prolongation with clinical significance, QTc interval>470ms (females) or 480ms
(males), type 2 second-degree atrioventricular block or third-degree
atrioventricular block
- Patients with HbsAg positive are required to have HBV DNA<1.0×10^3 IU/ml before
entering the group. In addition, if the patient is HBsAg negative but HBcAb positive
(regardless of HBsAb status), HBV DNA test is also required, and HBV DNA<1.0×10^3
IU/ml is required before entering the group
- Patients with psychiatric disorders or patients who are known or suspected to be
unable to fully comply with the study protocol
- HIV-infected patients
- History of stroke or intracranial hemorrhage within 6 months prior to start of
therapy
- Other medical conditions determined by the researchers that may affect the study
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Institute of Hematology, Rui-Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Weili Zhao
Phone:
+862164370045
Phone ext:
610707
Email:
zwl_trial@163.com
Contact backup:
Last name:
Pengpeng Xu
Phone:
+862164370045
Phone ext:
610707
Email:
pengpeng_xu@126.com
Start date:
July 29, 2024
Completion date:
August 10, 2029
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06522555
