A Study of ICP-022 in Patients With R/R DLBCL

  • STATUS
    Recruiting
  • participants needed
    85
  • sponsor
    Beijing InnoCare Pharma Tech Co., Ltd.
Updated on 19 February 2024
lymphoma
b-cell lymphoma
diffuse large b-cell lymphoma
large b-cell lymphoma
btk inhibitor

Summary

It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R DLBCL. There will be no control group in this study. Each subject will receive treatment orally every day in 28-day cycles. Each cycle starts immediately after the previously completed cycle without a break between cycles.

Details
Condition Diffuse Large B-Cell Lymphoma
Age 18-75 years
Treatment ICP-022
Clinical Study IdentifierNCT04438005
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women between 18 and 75 years old
Histologically confirmed diffuse large B-cell lymphomaDLBCLwith MyD88 L265P and CD79B positive, at least one measurable tumor of greater than 1.5 centimeter in long axis by contrast-enhanced CT/MRI
ECOG performance status of 0-2
Voluntary written informed consent prior to trail screening

Exclusion Criteria

History of other active malignancies, unless cured without evidence of relapse or metastasis within 5 years of study entry
History of Richter's syndrome
Current or history of lymphoma involved central nervous system
Prior corticosteroids (at dosages equivalent to prednisone > 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation therapy, or antibody based therapies or anti-cancer TCM within 4 weeks of the start of study drug
The investigator considers other conditions unsuitable for this study
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Clear my responses

How to participate?

Step 1 Connect with a study center
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

Primary Contact

site

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