Active not recruitingPHASE3INTERVENTIONAL

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

This study is for people with follicular lymphoma or marginal zone lymphoma where their cancer has returned or didn't get better with previous treatments. It's investigating a new medicine called tafasitamab. Participants will receive tafasitamab along with two existing drugs, lenalidomide and rituximab, or they will receive a dummy drug (placebo) with lenalidomide and rituximab. Researchers want to find out if adding tafasitamab improves the treatment and makes patients feel better compared to the standard approach. This is a 'Phase 3' study, meaning it's a large trial to confirm if the new treatment is safe and effective before it can be widely used.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Incyte Corporation

Enrolment target

654

Start

15 Apr 2021

Estimated completion

09 Aug 2028

Follicular Lymphoma Marginal Zone Lymphoma

What is this study about?

This study is for adults in the UK who have been diagnosed with a type of slow-growing lymphoma called follicular lymphoma or marginal zone lymphoma. These conditions are types of cancer that affect certain white blood cells.

Sometimes, after initial treatment, these lymphomas can come back (this is called 'relapsed') or they might not respond well to treatment (this is called 'refractory'). If this has happened to you, this study might be an option to consider.

The main aim of this study is to see if adding a new drug called tafasitamab to two existing treatments, lenalidomide and rituximab, works better than using lenalidomide and rituximab alone. Researchers want to understand if this new combination can more effectively control the lymphoma and improve patients' health. Your doctor can help you understand if this study might be suitable for you.

Key takeaways

The study investigates a new drug, tafasitamab, for lymphoma that has returned or not responded to prior treatment.
It aims to see if adding tafasitamab improves treatment compared to standard care.
Participants will receive either the new drug or a dummy pill alongside existing treatments.
This is a large 'Phase 3' study to test safety and effectiveness.
You will have regular hospital visits for monitoring and tests.
You can stop participating at any time if you change your mind.

Who may be eligible?

To be able to join this study, your doctor will first check that you meet certain requirements. You must have been diagnosed with follicular lymphoma or marginal zone lymphoma that has either returned or hasn't responded well to at least one previous course of treatment, including a type of therapy called anti-CD20 (like rituximab) or chemo-immunotherapy.

You must be 18 years old or older, and your general health should be good enough to take part in the study, as assessed by your doctor. Both men and women can participate, but if you are a woman who is pregnant or breastfeeding, you would not be able to join. Men and women need to be willing to use effective birth control if there's any chance of pregnancy during the study.

There are also some conditions that would prevent someone from joining, such as having certain other serious health problems like specific heart conditions, untreated serious infections, or a history of some other cancers. You also can't have had lenalidomide and rituximab together before. Your doctor will carefully review all the requirements with you.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with follicular lymphoma or marginal zone lymphoma?
Has your lymphoma come back or not responded well after at least one previous treatment?
Are you able and willing to use effective birth control if there's any chance of pregnancy?
Are you generally well enough, as assessed by your doctor, to take part in a study?
Are you not pregnant or breastfeeding?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you would be randomly assigned to one of two groups. One group will receive tafasitamab along with lenalidomide and rituximab, and the other group will receive a dummy drug (placebo) along with lenalidomide and rituximab. Neither you nor your study doctor would know which group you are in, which helps make the study results as fair as possible.

Throughout the study, you would have regular visits to the hospital or clinic. These visits will involve various tests and checks, such as blood tests, scans, and physical examinations, to monitor your health and how the treatment is working. You will receive the study medication as prescribed by the study team. The duration of treatment and follow-up will be explained in detail by the study team, but these types of studies often involve several months or even a year or more of active treatment, followed by a period of observation.

Potential risks and benefits

Taking part in any clinical study has potential benefits and potential risks. You might benefit from a new treatment that could be more effective than current options, though there's no guarantee the treatment will work for you. On the other hand, there might be side effects from the study drugs, some of which could be serious. The study team will provide you with detailed information about all known and potential side effects. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (261)

John Muir Health Clinical Research Center
Concord, United States
Marin Cancer Care
Greenbrae, United States
The Oncology Institute of Hope and Innovation
Pasadena, United States
Sharp Memorial Hospital
San Diego, United States
Middlesex Hospital Cancer Center
Middletown, United States
Smilow Cancer Hospital
New Haven, United States
Cancer Specialists of North Florida
Jacksonville, United States
Brcr Medical Center, Inc
Plantation, United States
Asclepes Research Centers
Weeki Wachee, United States
Northwest Georgia Oncology Centers,P.C
Marietta, United States
Straub Medical Center
Honolulu, United States
Des Moines Oncology Research Association
Des Moines, United States

+249 more sites — see the official record for the full list.

Common questions

What is a 'Phase 3' study?

Phase 3 is a large study to confirm if a new treatment is safe and works better than existing options before it can be approved for wider use.

What is a 'placebo'?

A placebo is a dummy drug that looks like the real treatment but has no active ingredients. It helps researchers compare the new drug's effects.

Will I know if I'm getting the new drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until the study is complete, unless there's a medical need to find out sooner.

Can I still receive my normal care if I join?

Yes, any medical care you usually receive will continue, and you can withdraw from the study at any time without it affecting your regular treatment.

What are follicular lymphoma and marginal zone lymphoma?

These are types of slow-growing cancer that affect certain white blood cells in your body.