Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592170
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-07
Brief Title:
Linperlisib Combination With Obinutuzumab Frontline Treatment of Marginal Zone Lymphoma Patients MZL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Arm Open Center Multicenter Clinical Study of Frontline Treatment of Marginal Zone Lymphoma Patients MZL With Linperlisib Combined With Obinutuzumab
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MZL-001
Brief Summary:
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
Detailed Description:
This study is a single arm open label multicenter Phase IbII 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 Iflt2 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 cyclesThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None