Clinical trial NCT04438005: A Study of ICP-022 in Patients With R/R DLBCL
Official title: A Multicenter, Open-Label Study to Investigate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Keywords: Relapsed/Refractory
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Key Inclusion criteria：

1. Men and women between 18 and 75 years old,
2. 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,
3. ECOG performance status of 0-2,
4. Voluntary written informed consent prior to trail screening.

Key Exclusion criteria:

1. History of other active malignancies, unless cured without evidence of relapse or metastasis within 5 years of study entry
2. History of Richter's syndrome
3. Current or history of lymphoma involved central nervous system
4. 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.
5. The investigator considers other conditions unsuitable for this study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Overall response rate（ORR）
timeFrame: Up to 3 years
Secondary outcomes:
measure: Occurrence of adverse events and serious adverse events
timeFrame: Up to 3 years
measure: Progression free survival（PFS）
timeFrame: Up to 3 years
measure: Duration of response（DOR）
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Haerbin
country: China
facility: Affiliated Tumor Hospital of Harbin Medical University
state: Heilongjiang
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Hebei
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Shijiazhuang
city: Tianjin
country: China
facility: Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University Medical College
state: Zhejiang
Study officials:
References: