CO41942: Mosunetuzumab + Lenalidomide in Participants With Follicular Lymphoma

CO41942: Mosunetuzumab + Lenalidomide in Participants With Follicular Lymphoma

Es posible que algunos contenidos no estén disponibles en español.

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
For more information, contact the study team at terri.lucas@duke.edu.

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