A Phase Ib Study of YY-20394 in Participants With B-cell Hematologic Malignancies
Primary Purpose
Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone Lymphoma
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
YY-20394
Sponsored by
About this trial
This is an interventional treatment trial for Small Lymphocytic Lymphoma
Eligibility Criteria
Inclusion Criteria:
- histologically or cytologically confirmed relapse and/or refractory B cell hematologic malignancies(Excluding follicular lymphoma)
- prior treatment with ≥1 prior standard anti-tumor regimens and 2 courses of treatments at least
- eastern cooperative oncology group performance status of 0 to 2
- life expectancy of at least 3 months
- presence of >1.5cm radiographically measurable lymphadenopathy or extranodal lymphoid malignancy, and legibility in two vertical directions
- acceptable organ functions
- discontinuation of all other antitumor therapies before the first drug dose administration
- for men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up six periods
- willingness and ability to provide written informed consent and to comply with the protocol requirements
Exclusion Criteria:
- prior therapy with PI3K-delta inhibitors(except the intolerable subjects)
- the dosage of steroid hormone(predisone equivalent) was greater than 20mg/d, and lasted for more than 14 days
- medical condition of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditional that may hamper compliance and/or absorption of the investigational product
- concurrent drugs which maybe prolong the QT during the study period
- subjects with central nervous system metastasis
- Prior or current medical condition of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc
- active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- known history of chronic active hepatitis B infection, chronic active hepatitis C
- known history of immunodeficiency, including HIV positive test, other acquired or congenital immunodeficiency disorders, organ transplantation or allogeneic bone marrow transplantation
- autologous hematopoietic stem cell transplantation was received within 90 days before the first dose administration
- prior or ongoing heart disease, including: angina pectoris, clinically significant arrhythmia, myocardial infarction, heart failure, and any other heart disease judged by the researchers not eligible to the study
- pregnancy or breastfeeding
- prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant or impair the assessment of study results
- receiving granulocyte colony-stimulating factor(GCSF) or blood transfusion within seven days before screening
- history of a non-lymphoma malignancy except for adequately treated local basal cell carcinoma of the skin and cervical carcinoma in situ
- subjects, in the opinion of the the Investigator, who are unsuitable to participate in the study for any other reason.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
YY-20394
Arm Description
treatment with YY-20394 will be continued until tumor progression or development of unacceptable toxicity.
Outcomes
Primary Outcome Measures
Adverse events evaluated by NCI CTCAE V5.0
incidence of adverse events and associated dose of YY-20394
Overall response rate
the percentage of participants achieving a complete response or partial response
disease control rate
the percentage of participants achieving a complete response or partial response or stable disease
Secondary Outcome Measures
Full Information
NCT ID
NCT04279405
First Posted
February 19, 2020
Last Updated
February 19, 2020
Sponsor
Shanghai YingLi Pharmaceutical Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04279405
Brief Title
A Phase Ib Study of YY-20394 in Participants With B-cell Hematologic Malignancies
Official Title
A Phase 1b Study to Assess the Safety and Efficacy of YY-20394 in Subjects With Recurrent and/or Refractory B-cell Hematologic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai YingLi Pharmaceutical Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Protocol YY-20394-007 is a phase1 open-label, single-arm, multi-centre study to assess the safety and efficacy of YY-20394 in participants with relapse and/or refractory B cell malignant hematological tumor. eligible participants will initiate oral therapy with YY-20394 at a starting dose of 80mg taken once per day. treatment with YY-20394 can continue in compliant participants as long as the study is still ongoing and the participants appear to benefiting from treatment with acceptable safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
YY-20394
Arm Type
Experimental
Arm Description
treatment with YY-20394 will be continued until tumor progression or development of unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
YY-20394
Intervention Description
YY-20394 80mg tablet administered orally once daily
Primary Outcome Measure Information:
Title
Adverse events evaluated by NCI CTCAE V5.0
Description
incidence of adverse events and associated dose of YY-20394
Time Frame
Throughout the study for approximately 2 years
Title
Overall response rate
Description
the percentage of participants achieving a complete response or partial response
Time Frame
Throughout the study for approximately 2 years
Title
disease control rate
Description
the percentage of participants achieving a complete response or partial response or stable disease
Time Frame
Throughout the study for approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically or cytologically confirmed relapse and/or refractory B cell hematologic malignancies(Excluding follicular lymphoma)
prior treatment with ≥1 prior standard anti-tumor regimens and 2 courses of treatments at least
eastern cooperative oncology group performance status of 0 to 2
life expectancy of at least 3 months
presence of >1.5cm radiographically measurable lymphadenopathy or extranodal lymphoid malignancy, and legibility in two vertical directions
acceptable organ functions
discontinuation of all other antitumor therapies before the first drug dose administration
for men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up six periods
willingness and ability to provide written informed consent and to comply with the protocol requirements
Exclusion Criteria:
prior therapy with PI3K-delta inhibitors(except the intolerable subjects)
the dosage of steroid hormone(predisone equivalent) was greater than 20mg/d, and lasted for more than 14 days
medical condition of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditional that may hamper compliance and/or absorption of the investigational product
concurrent drugs which maybe prolong the QT during the study period
subjects with central nervous system metastasis
Prior or current medical condition of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc
active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
known history of chronic active hepatitis B infection, chronic active hepatitis C
known history of immunodeficiency, including HIV positive test, other acquired or congenital immunodeficiency disorders, organ transplantation or allogeneic bone marrow transplantation
autologous hematopoietic stem cell transplantation was received within 90 days before the first dose administration
prior or ongoing heart disease, including: angina pectoris, clinically significant arrhythmia, myocardial infarction, heart failure, and any other heart disease judged by the researchers not eligible to the study
pregnancy or breastfeeding
prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant or impair the assessment of study results
receiving granulocyte colony-stimulating factor(GCSF) or blood transfusion within seven days before screening
history of a non-lymphoma malignancy except for adequately treated local basal cell carcinoma of the skin and cervical carcinoma in situ
subjects, in the opinion of the the Investigator, who are unsuitable to participate in the study for any other reason.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanying Bao, MD,PhD
Phone
86 21-51370693
Email
hybao@yl-pharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Shu, MMed
Phone
86 21-58328851
Ext
8117
Email
yshu@yl-pharma.com
12. IPD Sharing Statement
Learn more about this trial
A Phase Ib Study of YY-20394 in Participants With B-cell Hematologic Malignancies
We'll reach out to this number within 24 hrs