Study of Ibrutinib and Rituximab in Treatment Na ve Follicular Lymphoma

  • STATUS
    Recruiting
  • End date
    Jan 22, 2025
  • participants needed
    440
  • sponsor
    Pharmacyclics LLC.
Updated on 22 November 2020
Investigator
Divya Chari
Primary Contact
The Townsville Hospital (0.0 mi away) Contact
+216 other location
rituximab
measurable disease
follicular lymphoma
ibrutinib

Summary

The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment nave subjects with follicular lymphoma.

Details
Treatment Rituximab, Ibrutinib, placebo to match ibrutinib
Clinical Study IdentifierNCT02947347
SponsorPharmacyclics LLC.
Last Modified on22 November 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 60 yrs?
Gender: Male or Female
Do you have any of these conditions: Treatment Naive Follicular Lymphoma or Non-Hodgkin's Lymphoma or Lymphoma or Follicular Lymphoma?
Do you have any of these conditions: Lymphoma or Treatment Naive Follicular Lymphoma or Follicular Lymphoma or Non-Hodgkin's Lymphoma?
Do you have any of these conditions: Lymphoma or Follicular Lymphoma or Non-Hodgkin's Lymphoma or Treatment Naive Follicular Lymphoma?
Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease
Measurable disease
Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities
Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria
Adequate hematologic function within protocol-defined parameters
Adequate hepatic and renal function within protocol-defined parameters
ECOG performance status score of 0-2

Exclusion Criteria

Transformed lymphoma
Prior treatment for follicular lymphoma
Central nervous system lymphoma or leptomeningeal disease
Currently active, clinically significant cardiovascular disease
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

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

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

Learn more
Step 3 Enroll in the clinical study

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
Step 4 Get your study results

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

Study

user name

Annotated 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 made yet