This is a single arm, open label, national multicenter clinical study included patients with marginal zone lymphoma patients (MZL) , aim is to evaluate the efficacy and safety of first-line treatment with Linperlisib combined with obinutuzumab in patients with marginal zone lymphoma (MZL).
This study is a single arm, open label, multicenter Phase Ib/II study aimed at evaluating the safety and efficacy of first-line treatment of patients with marginal zone lymphoma with combination therapy of Linperlisib and obinutuzumab. The study is divided into Phase Ib safety introduction stage, and Phase II is recommended; As well as the Phase II expansion phase, the research design is shown in the following figure. Phase Ib is the safety introduction period, with the main purpose of determining the recommended Phase II effective dose (RP2D) based on dose limiting toxicity (DLT). Six subjects are planned to be enrolled to observe the safety of one cycle of combination therapy with Linperlisib (80 mg, once daily). If\<2 cases of DLT occur, the RP2D of Linperlisib will be 80 mg, once daily; If there are ≥ 2 cases of DLT, RP2D is 60 mg once daily. Phase II is the expansion phase, which involves induction therapy with two cycles of Linperlisib RP2D combined with obinutuzumab. All patients who achieve complete remission (CR) or partial remission (PR) after induction therapy receive induction therapy with a dose of Linperlisib, which is maintained every 28 days for one cycle until disease progression or other reasons lead to discontinuation. During the maintenance phase, the use of Linperlisib should not exceed 24 months. If the disease is stable (SD) or (PD), the patient will be removed from the group. If a patient fails to achieve CP or PR after two cycles of induction therapy, the researcher will determine whether to continue induction therapy. Induction therapy can last up to six cycles.The aim is to evaluate the efficacy and safety of first-line treatment with Linperlisib combined with obinutuzumab in patients with marginal zone lymphoma (MZL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Safe import period: Linperlisib: 80 mg, oral (pre - and post meal), QD; obinutuzumab: 1000 mg, intravenous infusion, administered on the first day (1st cycle on days 1, 8, and 15); Every 28 days, there is one cycle in total. Extended treatment period: Combination induction: Linperlisib: RP2D, oral (pre - and post meal), QD; obinutuzumab: 1000 mg/time, intravenous infusion, administered on the first day (1st cycle on days 1, 8, and 15); Every 28 days, there are 2 cycles in total. Afterwards, single drug maintenance: Linperlisib: RP2D, oral (before and after meals), QD; every 28 days per cycle.
The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGComplete response(CR) according to the RECIST 1.1
The CR rate of patients with Linperlisib in combination with Obinutuzumab for marginal zone lymphoma
Time frame: 6 months from the start of linperlisib treatment
Objective Response Rate (ORR) according to the RECIST 1.1
The ORR rate of patients with Linperlisib in combination with Obinutuzumab for marginal zone lymphoma
Time frame: 6 months from the start of linperlisib treatment
Duration of Overall Response (DOR)
The time from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD).
Time frame: Within 2 year from the start of Linperlisib treatment,the time from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD)
Adverse event
Refers to adverse medical events that occur in the clinical trial process of the subject
Time frame: Within 2 year from the start of Linperlisib treatment
Disease control rate(DCR)
Proportion of patients with remission (PR+CR) and stable disease (SD) within 2 years after Linperlisib treatment.
Time frame: Within 2 year from the start of Linperlisib treatment
Progression-free survival(PFS)
The time from the start of clinical trials to the occurrence (in any aspect) of tumor progression or death due to any reason
Time frame: Within 2 years of initiation of Linperlisib treatment
Ou Bai Ou Bai, MD/PHD, The First Hospital of Jilin University, MD/PHD
CONTACT
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