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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    85
  • sponsor
    Beijing InnoCare Pharma Tech Co., Ltd.
Updated on 24 January 2021
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, diffuse large cell lymphoma, diffuse large b cell lymphoma
Treatment ICP-022
Clinical Study IdentifierNCT04438005
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Diffuse Large B-Cell Lymphoma?
Do you have any of these conditions: Diffuse Large B-Cell Lymphoma or diffuse large b cell lymphoma or diffuse large cell lymphoma?
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
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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.

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

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