This is a single-arm, multicenter, open label phase II clinical study to evaluate the efficacy and safety of OLR in the treatment of initially treated mantle cell lymphoma.
Patients initially treated with mantle cell lymphoma were screened for OLR regimen according to study admission criteria. The study will accept up to 24 cycles of treatment until disease progression or intolerable toxicity occurs and subjects voluntarily withdraw informed consent. Patients undergoing hematopoietic stem cell transplantation after complete remission may begin stem cell collection after induction therapy for at least 6 months. Twenty-nine patients are expected to be enrolled
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Induction treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: Cycle 1: 15mg QD D1-21, if no dose-limiting toxicity occurred in Cycle 1, cycle 2-6: 20mg QD D1-21; Cycle 1: 375 mg/m2 d1, 8,15,22; Cycle 3, 5: 375 mg/m2 D1 Maintenance treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: cycle 7-24: 15mg QD D1-21; Cycle 7, 9, 11, 13, 15, 17, 19, 21, 23: 375 mg/m2 D1. 28 days for a cycle.
Tianjin Medical University Cancer Insititute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGComplete Response Rate
The proportion of patients receiving the treatment with complete remission
Time frame: At the end of Cycle 6(each cycle is 28 days)
Objective Response Rate
The proportion of patients with response of PR and CR.
Time frame: Approximately 2 years
Time to Response
Measured from the date of initiation of treatment to the time of response
Time frame: Approximately 1 year
The Progression Free Survival Rate in 2 Years
The proportion of patients who didn't achieve disease progression or death in 2 years.
Time frame: 2 Years
The Overall Survival Rate in 2 Years
The proportion of patients who didn't achieve death in 2 years
Time frame: 2 Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.