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

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    Beijing InnoCare Pharma Tech Co., Ltd.
Updated on 24 January 2021
b-cell lymphoma
btk inhibitor


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.

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


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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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