This phase 1b/2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).
The Aim of this phase 1b/2 trial (MIL62 Plus Lenalidomide) is to find the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
1000mg /dose for 12 cycles(28 days) and a total of 11 doses :the first Cycle(Day1,Day15), the 2nd-8th Cycles(Day 1 every cycle);the 9th-12nd Cycles (One dose every two cycles).
Dose on days 2-22 every 28 days x 12 cycles: the starting dose is 10-mg ; Adjusted dose according to the tumor response or toxicity reaction
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
RECRUITINGPercentage of Participants With an Objective Response of Complete Response
Percentage of Participants With an Objective Response of Complete Response
Time frame: Baseline to 1 month after the last dose of last patient
Kaplan-Meier Estimate of Duration of Response
Kaplan-Meier Estimate of Duration of Response
Time frame: Baseline to 1 month after the last dose of last patient
Percentage of Participants With Disease Control
Percentage of Participants With Disease Control
Time frame: Baseline to 1 month after the last dose of last patient
Participants With 1 Year Progression Free Survival
Participants With 1 Year Progression Free Survival
Time frame: Baseline to 1 month after the last dose of last patient
Number of Participants With Treatment Emergent Adverse Events
Number of Participants With Treatment Emergent Adverse Events
Time frame: up to the 1 month the last dose of last subject
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