A Phase 2, Single-Arm, Open-Label Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy by Immune Effector Cell Therapy

  • STATUS
    Recruiting
Updated on 23 November 2020
cancer
hematologic cancer

Summary

The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib once daily for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning to receive tisagenlecleucel or axicabtagene ciloleucel immune effector cell (IEC) therapy for any approved hematologic indication.

Description

For more information, please contact Incyte Corporation at 1.855.463.3463

Details
Condition Hematologic Cancer
Clinical Study IdentifierTX246587
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Eligible to receive either tisagenlecleucel or axicabtagene ciloleucel for approved hematologic indications
Eastern Cooperative Oncology Group performance status 0 to 1
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Healthy Volunteers
Evidence of active uncontrolled/untreated infection (viral, bacterial, fungal, opportunistic) of any origin
Evidence of active hepatitis B virus or hepatitis C virus infection
Known human immunodeficiency virus
Active acute or chronic graft-versus-host disease requiring systemic therapy
Concurrent use of chronic systemic steroids or immunosuppressant medications
Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy
Known history or prior diagnosis of immunologic or inflammatory/ autoimmune disease affecting the central nervous system (CNS) and unrelated to their disease under study or previous treatment
Clinically significant or uncontrolled cardiac disease
Acute lymphoblastic leukemia participants with protocol-defined CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia
Diffuse large B-cell lymphoma participants must have no signs or symptoms of CNS disease or detectable evidence of CNS disease; participants who have been previously treated for CNS disease but have no evidence of disease at screening are eligible
Laboratory values at screening outside the protocol-defined ranges
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note