All studies
Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

This study is looking at a new treatment called JCAR017 for adults whose non-Hodgkin lymphoma and specifically follicular lymphoma (FL) or marginal zone lymphoma (MZL) has come back or hasn't responded to previous treatments. It's a type of cell therapy. Researchers want to find out how effective JCAR017 is at treating the lymphoma and to understand any side effects it might have. This is a Phase 2 study, which means it's one of the earlier stages of testing new treatments in a group of people. The study will carefully follow participants for up to five years to see the long-term effects of the treatment. It's happening in various locations and follows strict international guidelines to ensure patient safety.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Celgene
Enrolment target
276
Start
14 Jul 2020
Estimated completion
30 Sep 2031

What is this study about?

This study is about exploring a new treatment called JCAR017 for a specific type of cancer called non-Hodgkin lymphoma. More precisely, it focuses on adults with follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has either returned after previous treatments or has not responded to those treatments. This new treatment, JCAR017, is a type of cell therapy. In cell therapy, your own immune cells are collected, modified in a lab to better fight cancer, and then given back to you.

The main goals of the study are to see how well JCAR017 works in shrinking or getting rid of the lymphoma, and to identify any potential side effects or safety concerns. By understanding both the good and bad effects, doctors can learn if this treatment could be a valuable option for people in the future. This is a 'Phase 2' study, which means it's an important step in testing new treatments on a group of people, after earlier safety tests. The study is being conducted worldwide and follows very strict rules to make sure patient safety comes first and the results are reliable.

The findings from this study will help healthcare professionals understand if JCAR017 can offer a new and effective way to treat patients with these specific types of lymphoma when other treatments haven't worked or when the cancer has returned. It's an important step in advancing our understanding and battling these conditions.

Key takeaways

  • This study is testing a new cell therapy (JCAR017) for specific types of non-Hodgkin lymphoma.
  • It's for adults whose lymphoma has not responded to or has returned after previous treatments.
  • The study aims to see how well the treatment works and if it's safe.
  • Participation involves cell collection, a short course of chemotherapy, and then the JCAR017 treatment.
  • You will be closely monitored for one month after treatment, followed by check-ups for five years.
  • All known risks and benefits will be fully explained, and you can withdraw at any time.

Who may be eligible?

To join this study, you would generally need to be an adult with follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has either returned or not responded to past treatments. Specifically, your lymphoma diagnosis needs to be recent, and you should have already received at least one prior treatment that included certain medications like anti-CD20 and an alkylating agent. If you have follicular lymphoma, you might qualify after one previous treatment if your disease has certain high-risk features, or after two or more treatments if one included the specific medications mentioned. If you have marginal zone lymphoma, you'd typically need two or more prior treatments with those specific medications, or if your lymphoma came back after a stem cell transplant. You also need to be generally fit and healthy enough, meaning your body's main organs are working well, and you have good overall daily function.

There are also some reasons why you might not be able to join. For example, if your lymphoma has spread to certain parts of your central nervous system, or if you have another type of lymphoma called Diffuse Large B-cell Lymphoma (DLBCL) combined with follicular lymphoma. You also wouldn't be able to participate if you've had a type of cell therapy like CAR T-cell therapy before, or if you have certain active infections like HIV, Hepatitis B or C, or uncontrolled other infections. Other reasons include specific heart conditions, active autoimmune diseases needing strong medication, or if you have certain other serious health issues that could make the treatment unsafe for you.

Quick self-check
  • Are you an adult with follicular lymphoma (FL) or marginal zone lymphoma (MZL)?
  • Has your lymphoma returned or not responded to other treatments?
  • Have you had at least one prior treatment that included anti-CD20 and an alkylating agent?
  • Are your body's major organs, like your heart, liver, and kidneys, working well?
  • Have you ever had CAR T-cell therapy or a similar genetically-modified cell therapy before? (If yes, you likely can't join)
  • Do you have any serious active infections like HIV, Hepatitis B or C, or an uncontrolled infection?

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

What does participation involve?

If you decide to take part in this study, your journey will be split into three main parts. First, there's the 'Pretreatment' period. This involves several checks and tests to confirm you're suitable for the study. A key part of this is a procedure called 'leukapheresis,' where some of your white blood cells are collected. These cells are then sent away to be specially prepared for the JCAR017 treatment.

Next is the 'Treatment' period. Before you receive JCAR017, you'll have a short course of chemotherapy medications (Fludarabine and Cyclophosphamide). This is done to prepare your body for the cell therapy. A few days later, you'll receive the JCAR017 cells as a one-time infusion (like a drip). You'll then be closely monitored for about a month to check how you're responding and for any immediate side effects.

Finally, there's a long 'Posttreatment' period, which lasts for five years. During this time, you'll have regular check-ups with the study team. These visits will involve various tests and assessments to see how your lymphoma is doing, whether the treatment continues to work, and to monitor your long-term health and any late side effects. You'll be supported throughout the entire study.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as access to a new treatment (JCAR017) that is not yet widely available and might help your lymphoma when other treatments haven't worked. You would also be contributing to medical research, which could help future patients. However, there are also potential risks. New treatments can have side effects that are not fully known, and some side effects can be serious. The chemotherapy you receive before JCAR017 also has known side effects, and the cell collection process (leukapheresis) has its own minor risks. The research team will carefully explain all known and potential risks to you. Remember, joining a study is always your choice, and you are free to withdraw at any time without affecting your future medical care.

Locations (49)

  • Local Institution - 111
    Santa Monica, United States
  • Local Institution - 107
    Aurora, United States
  • Local Institution - 105
    New Haven, United States
  • Local Institution - 103
    Chicago, United States
  • Local Institution - 109
    Niles, United States
  • Local Institution - 122
    Iowa City, United States
  • Local Institution - 124
    Wichita, United States
  • Local Institution - 102
    Baltimore, United States
  • Local Institution - 100
    Boston, United States
  • Local Institution - 101
    Boston, United States
  • Local Institution - 127
    Detroit, United States
  • Local Institution - 123
    Morristown, United States

+37 more sites — see the official record for the full list.

Common questions

What is non-Hodgkin lymphoma?

Non-Hodgkin lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of your body's immune system.

What is JCAR017?

JCAR017 is a new experimental treatment called a 'CAR T-cell therapy'. It involves taking your own immune cells, adapting them in the lab to fight your cancer, and then giving them back to you.

What does 'relapsed or refractory' mean?

This means your lymphoma has either come back after treatment (relapsed) or it hasn't responded to previous treatments (refractory).

Will I have to pay to be in the study?

No, you will not have to pay for the study treatment or related procedures. Any specific questions about costs or travel should be discussed with the study team.

How long will the treatment process last?

The active treatment and initial close monitoring period happens over about a month. However, you'll be followed by the study team with regular check-ups for up to five years after receiving the treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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