Status:
COMPLETED
A Study of ICP-022 in Patients With R/R DLBCL
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 n...
Eligibility Criteria
Inclusion
- Key Inclusion criteria：
- Men and women between 18 and 75 years old,
- Histologically confirmed diffuse large B-cell lymphoma（DLBCL）with 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.
- Key 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.
Exclusion
Key Trial Info
Start Date :
May 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04438005
Start Date
May 7 2020
End Date
December 13 2021
Last Update
May 13 2024
Active Locations (7)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
2
Affiliated Tumor Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
3
Jiangsu Province Hospital
Nanjing, Jiangsu, China
4
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China