This is A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma to Evaluate the Efficacy and Safety in Mantle Cell Lymphoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Orelabrutinib will be administered as 3 tablets once per day
Orelabrutinib will be administered as 1 tablet once per day
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Objective response rate(ORR)
Proportion of subjects with tumor response of Complete Response(CR) or Partial Response(PR) after treatment in total subjects.
Time frame: Through study completion, an average of 2 year
Complete Response Rate (CRR)
The proportion of subjects with tumor response of Complete Response(CR) after treatment in total subjects.
Time frame: Through study completion, an average of 2 year
Progression-Free Survival (PFS)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Time frame: Through study completion, an average of 2 year
Duration of Response (DoR)
The time from documentation of objective response to the first occurrence of tumor progression or death due to any cause, whichever occurs first.
Time frame: Through study completion, an average of 2 year
Maximum concentration (Cmax,ss)
Time frame: Predose up to 24 hours postdose
Time to maximum concentration (Tmax)
Time frame: Predose up to 24 hours postdose
Area under the plasma concentration-time curve (AUC)
Time frame: Predose up to 24 hours postdose
Half-life (T1/2)
Time frame: Predose up to 24 hours postdose
Apparent clearance (CL/F)
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou, China
Nanyang Second General Hospital
Nanyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
...and 10 more locations
Time frame: Predose up to 24 hours postdose
Adverse events(AEs)
Time frame: Through study completion, an average of 2 year
Serious adverse events (SAEs)
Time frame: Through study completion, an average of 2 year