Diffuse Large B Cell Lymphoma
Conditions
Keywords
Relapsed/Refractory
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.
Interventions
DRUGICP-022
ICP-022 is a white, round, uncoated tablet, 50 mg. It is administered orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate（ORR） | Up to 3 years | The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse events and serious adverse events | Up to 3 years | The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 5.0 grading criteria |
| Progression free survival（PFS） | Up to 3 years | The efficacy measured by progression free survival（PFS） |
| Duration of response（DOR） | Up to 3 years | — |
Countries
China
Outcome results
None listed