Purpose of this Study
We are doing this study to find out if an experimental drug called mosunetuzumab (the study drug) is a safe and effective option for patients with follicular lymphoma.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with follicular lymphoma
- Have disease that is CD20-positive
- Have previously received at least one line of systemic lymphoma therapy, which includes prior immunotherapy or chemoimmunotherapy
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will take part in 2 stages: a non-randomized stage and a randomized stage.
The non-randomized stage of this study is to test the safety of the study drug (in combination with lenalidomide). Non-randomized means that everyone will have the same regimen and not get a random assignment to different intervention groups. You will be enrolled in either the dose-escalation phase or the expansion phase. Whichever study phase you are enrolled in, you may receive mosunetuzumab plus lenalidomide for approximately 12 months. The study drug can be given either intravenously (through a needle in your vein) or subcutaneously (injection under the skin) on Day 1, Day 8, and Day 15 of C1 and Day 1 of every cycle thereafter. A "cycle" is a 21-day period of use of the study drug. Lenalidomide is taken daily, by mouth, at home for 21 days from cycle 2 onwards.
The randomized stage of this study is to test the safety of the study drug given through the vein (IV) compared to the study drug as an injection under the skin (SC injection), each in combination with lenalidomide. If you are enrolled in the randomized stage, you will be assigned by chance to either Group A or Group B:
- Group A will receive IV (through the vein) mosunetuzumab in combination with lenalidomide. Lenalidomide is taken daily, by mouth, at home.
- Group B will receive SC (under the skin) mosunetuzumab in combination with lenalidomide.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase Ib/Ii, Open-Label, Multicenter Study With A Non-Randomized Stage Evaluating The Safety, Pharmacokinetics, And Efficacy Of Mosunetuzumab Plus Lenalidomide (+ Len), And A Randomized Stage Evaluating The Safety, Tolerability, And Pharmacokinetics Of Sc Versus Iv Mosunetuzumab + Len In Patients With Follicular Lymphoma
Principal Investigator
Matthew
McKinney
Protocol Number
PRO00117522
NCT ID
NCT04246086
Phase
I/II
Enrollment Status
Pending Open to Enrollment