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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Adverse events evaluated by NCI CTCAE V5.0
Condition
Small Lymphocytic Lymphoma
Intervention
YY-20394
Study Arms / Comparison Groups
YY-20394
Description: treatment with YY-20394 will be continued until tumor progression or development of unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
80
Start Date
April 2020
Completion Date
December 2021
Primary Completion Date
September 2021
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 86 21-51370693, [email protected]
Administrative Informations
NCT ID
NCT04279405
Organization ID
YY-20394-007
Responsible Party
Sponsor
Study Sponsor
Shanghai YingLi Pharmaceutical Co. Ltd.
Study Sponsor
, ,
Verification Date
October 2019